Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:27 PM
Study NCT ID:
NCT01031069
Status:
COMPLETED
Last Update Posted:
2020-07-21
First Post:
2009-12-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluation of Safety and Immunogenicity of a Human Papillomavirus (HPV) Vaccine in Human Immunodeficiency Virus (HIV) Infected Females
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D030361', 'term': 'Papillomavirus Infections'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C510352', 'term': 'human papillomavirus vaccine, L1 type 16, 18'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D000068857', 'term': 'Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18'}], 'ancestors': [{'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D017778', 'term': 'Vaccines, Combined'}, {'id': 'D053918', 'term': 'Papillomavirus Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).', 'eventGroups': [{'id': 'EG000', 'title': 'HIV+/Cervarix Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.', 'otherNumAtRisk': 129, 'deathsNumAtRisk': 129, 'otherNumAffected': 123, 'seriousNumAtRisk': 129, 'deathsNumAffected': 0, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'HIV+/Gardasil Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.', 'otherNumAtRisk': 128, 'deathsNumAtRisk': 128, 'otherNumAffected': 109, 'seriousNumAtRisk': 128, 'deathsNumAffected': 1, 'seriousNumAffected': 9}, {'id': 'EG002', 'title': 'HIV-/Cervarix Group', 'description': 'HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.', 'otherNumAtRisk': 144, 'deathsNumAtRisk': 144, 'otherNumAffected': 136, 'seriousNumAtRisk': 144, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'HIV-/Gardasil Group', 'description': 'HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.', 'otherNumAtRisk': 145, 'deathsNumAtRisk': 145, 'otherNumAffected': 127, 'seriousNumAtRisk': 145, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Abscess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Acarodermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Adenoma benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Administration site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Administration site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Anogenital warts', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 64, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 56, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 144, 'numEvents': 40, 'numAffected': 31}, {'groupId': 'EG003', 'numAtRisk': 145, 'numEvents': 47, 'numAffected': 34}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Bacterial vaginosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Bartholinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Blindness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Body tinea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Breast mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Burns second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cd4 lymphocytes decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cerumen impaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cervicitis gonococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dermatophytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 145, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 144, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 145, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, 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infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Vaginitis gardnerella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cervical dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 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'127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV+/Cervarix Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'OG001', 'title': 'HIV+/Gardasil Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}], 'classes': [{'title': 'Any Pain, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '115', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 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'25', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Swelling, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Pain, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Pain, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Any Redness, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Redness, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Swelling, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Pain, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Pain, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any Redness, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Redness, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Swelling, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Pain, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '120', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Pain, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Any Redness, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Redness, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Swelling, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after each vaccine dose and across doses', 'description': 'Assessed solicited local symptoms were pain, redness, swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling with a maximum diameter greater than 50 millimeters (mm).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had available symptom sheets completed.'}, {'type': 'PRIMARY', 'title': 'Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV+/Cervarix Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'OG001', 'title': 'HIV+/Gardasil Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}], 'classes': [{'title': 'Any Arthralgia, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Arthralgia, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related Arthralgia, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Any Fatigue, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fatigue, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Fatigue, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Any Gastrointestinal, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Gastrointestinal, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Gastrointestinal, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Any Headache, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 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{'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Any Urticaria, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Urticaria, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Urticaria, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after each vaccine dose and across doses', 'description': 'Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal \\[nausea, vomiting, diarrhoea and/or abdominal pain\\], headache, myalgia, rash, temperature \\[defined as axillary temperature higher than (\\>) 37.5 degrees Celsius (°C)\\] and urticaria. Any = occurrence of the symptom regardless of intensity grade and relationship. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature \\> 39.0 °C. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Related = symptom assessed by the investigator as related to the vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had available symptom sheets completed.'}, {'type': 'PRIMARY', 'title': 'Number of HIV+ Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV+/Cervarix Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'OG001', 'title': 'HIV+/Gardasil Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}], 'classes': [{'title': 'Any AE(s)', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 AE(s)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Related AE(s)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after any vaccination', 'description': 'An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 symptom = symptom that prevented normal activity. Related = symptom assessed by the investigator as related to the vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort for analysis of safety, which included all subjects with at least one vaccine administration documented.'}, {'type': 'PRIMARY', 'title': 'Number of HIV+ Subjects With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV+/Cervarix Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'OG001', 'title': 'HIV+/Gardasil Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)', 'description': 'SAEs assessed include any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or represented a congenital anomaly/birth defect in the offspring of a study subject.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort for analysis of safety, which included all subjects with at least one vaccine administration documented.'}, {'type': 'PRIMARY', 'title': 'Number of HIV+ Subjects With Medically Significant Conditions (MSCs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV+/Cervarix Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'OG001', 'title': 'HIV+/Gardasil Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)', 'description': 'Medically significant conditions (MSCs) are defined as AEs prompting emergency room or physician visits that were not related to common diseases, or not related to routine visits for physical examination or vaccination, SAEs that were not related to common diseases.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort for analysis of safety, which included all subjects with at least one vaccine administration documented.'}, {'type': 'PRIMARY', 'title': 'Number of HIV+ Subjects With Potential Immune-mediated Diseases (pIMDs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV+/Cervarix Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'OG001', 'title': 'HIV+/Gardasil Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)', 'description': 'Potential immune-mediated diseases are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort for analysis of safety, which included all subjects with at least one vaccine administration documented.'}, {'type': 'PRIMARY', 'title': 'Number of HIV+ Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV+/Cervarix Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'OG001', 'title': 'HIV+/Gardasil Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}], 'classes': [{'title': 'Live infant NO apparent congenital anomaly', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Live infant congenital anomaly', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Elective termin. NO apparent congenital anomaly', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Elective termin. congenital anomaly', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Ectopic pregnancy', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Spontaneous abortion NO apparent congen. anomaly', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Stillbirth NO apparent congenital anomaly', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Stillbirth congenital anomaly', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lost to follow-up', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pregnancy ongoing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)', 'description': 'Pregnancy related outcomes were: live infant no apparent congenital anomaly, live infant congenital anomaly, elective termination (termin.) no apparent congenital anomaly, elective termination (termin.) congenital anomaly, ectopic pregnancy, spontaneous abortion no apparent congenital (congen.) anomaly, stillbirth no apparent congenital anomaly, stillbirth congenital anomaly, lost to follow-up, pregnancy ongoing, missing.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who reported any pregnancies and outcomes of reported pregnancies.'}, {'type': 'PRIMARY', 'title': 'Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV+/Cervarix Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'OG001', 'title': 'HIV+/Gardasil Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}], 'classes': [{'title': 'ALAT, Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ALAT, Below', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'ALAT, Within', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}]}, {'title': 'ALAT, Above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'BSPH, Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'BSPH, Below', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'BSPH, Within', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '120', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}]}, {'title': 'BSPH, Above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'CRT, Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'CRT, Below', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'CRT, Within', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}]}, {'title': 'CRT, Above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ESPH, Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ESPH, Below', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'ESPH, Within', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}]}, {'title': 'ESPH, Above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'HTCR, Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HTCR, Below', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'HTCR, Within', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}]}, {'title': 'HTCR, Above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'HGB, Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HGB, Below', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'HGB, Within', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}]}, {'title': 'HGB, Above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'LYMP, Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'LYMP, Below', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'LYMP, Within', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}]}, {'title': 'LYMP, Above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'MONO, Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'MONO, Below', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'MONO, Within', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}]}, {'title': 'MONO, Above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'NTPH, Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'NTPH, Below', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'NTPH, Within', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}]}, {'title': 'NTPH, Above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'PLAT, Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'PLAT, Below', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'PLAT, Within', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}]}, {'title': 'PLAT, Above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'RBC, Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'RBC, Below', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'RBC, Within', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}]}, {'title': 'RBC, Above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'WBC, Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'WBC, Below', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'WBC, Within', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}]}, {'title': 'WBC, Above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 7 (30 days after the last vaccination dose at Month 6)', 'description': 'Among assessed haematological and biochemical parameters were: alanine aminotransferase \\[ALAT\\], basophilis \\[BSPH\\], creatinine \\[CRT\\], eosinophils \\[ESPH\\], haematocrit \\[HTCR\\], haemoglobin \\[HGB\\], lymphocytes \\[LYMP\\], monocytes \\[MONO\\], neutrophils \\[NTPH\\], platelets \\[PLAT\\], red blood cells \\[RBC\\] and white blood cells \\[WBC\\]. Unknown = value unknown for the specified visit and laboratory parameter; Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available at Month 7.'}, {'type': 'PRIMARY', 'title': 'Cluster of Differentiation 4 (CD4+) Cell Count in HIV+ Subjects at Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV+/Cervarix Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'OG001', 'title': 'HIV+/Gardasil Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '554.0', 'groupId': 'OG000', 'lowerLimit': '440.0', 'upperLimit': '799.0'}, {'value': '568.0', 'groupId': 'OG001', 'lowerLimit': '457.0', 'upperLimit': '773.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Month 7 (30 days after the last vaccination dose at Month 6)', 'description': 'CD4+ cell count, expressed in cells/cubic millimeter (mm3), was assessed for HIV+ subjects.', 'unitOfMeasure': 'cells/mm3', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available at Month 7.'}, {'type': 'PRIMARY', 'title': 'HIV Viral Load (VL) in HIV+ Subjects at Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV+/Cervarix Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'OG001', 'title': 'HIV+/Gardasil Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '3.8'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '3.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Month 7 (30 days after the last vaccination dose at Month 6)', 'description': 'HIV VL, expressed in HIV copies/milliliter (mL), was assessed for HIV+ subjects.', 'unitOfMeasure': 'HIV copies/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available at Month 7.'}, {'type': 'PRIMARY', 'title': 'Number of HIV+ Subjects by World Health Organization (WHO) HIV Clinical Staging', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV+/Cervarix Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'OG001', 'title': 'HIV+/Gardasil Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}], 'classes': [{'title': 'Clinical Stage 1', 'categories': [{'measurements': [{'value': '113', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}]}, {'title': 'Clinical Stage 2', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Clinical Stage 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Clinical Stage 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Month 7 (30 days after the last vaccination dose at Month 6)', 'description': 'HIV+ subjects were categorised into clinical stages 1 through 4, as per the WHO classification \\[WHO, 2009\\].', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available at Month 7.'}, {'type': 'PRIMARY', 'title': 'Pseudovirion-Based Neutralization Assay (PBNA) Titers of Anti-HPV-16/18 Antibodies in HIV+ Subjects, Based on Adapted According-to-protocol (ATP) Cohort for Immunogenicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV+/Cervarix Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'OG001', 'title': 'HIV+/Gardasil Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}], 'classes': [{'title': 'Anti-HPV-16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23436.1', 'groupId': 'OG000', 'lowerLimit': '18186.4', 'upperLimit': '30201.1'}, {'value': '7507.0', 'groupId': 'OG001', 'lowerLimit': '5378.1', 'upperLimit': '10478.6'}]}]}, {'title': 'Anti-HPV-18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12490.9', 'groupId': 'OG000', 'lowerLimit': '9681.7', 'upperLimit': '16115.2'}, {'value': '1459.6', 'groupId': 'OG001', 'lowerLimit': '965.4', 'upperLimit': '2206.7'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.95', 'ciLowerLimit': '1.92', 'ciUpperLimit': '4.52', 'groupDescription': 'Adjusted GMT ratios for anti-HPV-16 neutra antibody (ED50): To demonstrate that the immunogenicity of Cervarix vaccine (HIV+/Cervarix Group) was non-inferior to that of Gardasil vaccine (HIV+/Gardasil Group), in terms of geometric mean titers (GMTs) against HPV-16, measured by Pseudovirion-based neutralization assay (PBNA) one month after the administration of the third dose of vaccine in HIV+ subjects.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority was defined as the lower limit of the 95% confidence interval (CI) for the ratio of GMTs (Cervarix over Gardasil) being above (\\>) 0.5 for HPV-16 type.', 'otherAnalysisDescription': 'Primary objectives were to be assessed sequentially: firstly, non-inferiority for both HPV-16 and HPV-18, and then, superiority for HPV-18 followed by superiority for HPV-16.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.83', 'ciLowerLimit': '4.84', 'ciUpperLimit': '12.66', 'groupDescription': 'Adjusted GMT ratios for anti-HPV-18 neutra antibody (ED50): To demonstrate that the immunogenicity of Cervarix vaccine (HIV+/Cervarix Group) was non-inferior to that of Gardasil vaccine (HIV+/Gardasil Group), in terms of geometric mean titers (GMTs) against HPV-18, measured by Pseudovirion-based neutralization assay (PBNA) one month after the administration of the third dose of vaccine in HIV+ subjects.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority was defined as the lower limit of the 95% confidence interval (CI) for the ratio of GMTs (Cervarix over Gardasil) being above (\\>) 0.5 for HPV-18 type.', 'otherAnalysisDescription': 'Primary objectives were to be assessed sequentially: firstly, non-inferiority for both HPV-16 and HPV-18, and then, superiority for HPV-18 followed by superiority for HPV-16.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 7 (30 days after the last vaccination dose at Month 6)', 'description': 'Titers of anti-HPV-16/18 antibodies, expressed as Geometric Mean Titers (GMTs), with cut-offs greater than or equal to (≥) 40 estimated dose giving 50% signal reduction when compared to a control without serum (ED50), as assessed by the Pseudovirion-Based Neutralization Assay \\[PBNA\\], in HIV+ subjects.\n\nBetween-group comparisons to assess non-inferiority were performed on the ATP cohort for immunogenicity (by PBNA, regardless of HPV serostatus at baseline).', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom Month 7 data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity at Month 7 were available.'}, {'type': 'PRIMARY', 'title': 'Pseudovirion-Based Neutralization Assay (PBNA) Titers of Anti-HPV-16/18 Antibodies in HIV+ Subjects, Based on Total Vaccinated Cohort (TVC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV+/Cervarix Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'OG001', 'title': 'HIV+/Gardasil Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}], 'classes': [{'title': 'Anti-HPV-16', 'categories': [{'measurements': [{'value': '21106.6', 'groupId': 'OG000', 'lowerLimit': '15961.3', 'upperLimit': '27910.6'}, {'value': '7533.7', 'groupId': 'OG001', 'lowerLimit': '5616.7', 'upperLimit': '10105.0'}]}]}, {'title': 'Anti-HPV-18', 'categories': [{'measurements': [{'value': '11580.5', 'groupId': 'OG000', 'lowerLimit': '8851.5', 'upperLimit': '15150.9'}, {'value': '1451.9', 'groupId': 'OG001', 'lowerLimit': '1009.0', 'upperLimit': '2089.2'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.44', 'ciLowerLimit': '4.79', 'ciUpperLimit': '11.54', 'groupDescription': 'Adjusted GMT ratios for anti-HPV-18 neutra antibody (ED50): To demonstrate that the immunogenicity of Cervarix vaccine (HIV+/Cervarix Group) was superior to that of Gardasil vaccine (HIV+/Gardasil Group), in terms of geometric mean titers (GMTs) against HPV-18, measured by Pseudovirion-based neutralization assay (PBNA) in HIV+ subjects, assessed following a sequential approach.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANOVA model on the log10 transformation of the titers for HIV+ subjects and including the vaccine group as fixed effect.', 'nonInferiorityComment': 'Superiority was defined as the lower limit of the 95% CI for the ratio of GMTs (Cervarix over Gardasil) being above 1 for HPV-18 type, with a statistically significant p-value.', 'otherAnalysisDescription': 'Primary objectives were to be assessed sequentially: firstly, non-inferiority for both HPV-16 and HPV-18, and then, superiority for HPV-18 followed by superiority for HPV-16.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.74', 'ciLowerLimit': '1.83', 'ciUpperLimit': '4.11', 'groupDescription': 'Adjusted GMT ratios for anti-HPV-16 neutra antibody (ED50): To demonstrate that the immunogenicity of Cervarix vaccine (HIV+/Cervarix Group) was superior to that of Gardasil vaccine (HIV+/Gardasil Group), in terms of geometric mean titers (GMTs) against HPV-16, measured by Pseudovirion-based neutralization assay (PBNA) in HIV+ subjects, following a sequential approach.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANOVA model on the log10 transformation of the titers for HIV+ subjects and including the vaccine group as fixed effect.', 'nonInferiorityComment': 'Superiority was defined as the lower limit of the 95% CI for the ratio of GMTs (Cervarix over Gardasil) being above 1 for HPV-16 type, with a statistically significant p-value.', 'otherAnalysisDescription': 'Primary objectives were to be assessed sequentially: firstly, non-inferiority for both HPV-16 and HPV-18, and then, superiority for HPV-18 followed by superiority for HPV-16.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 7 (30 days after the last vaccination dose at Month 6)', 'description': 'Titers of anti-HPV-16/18 antibodies, expressed as Geometric Mean Titers (GMTs), with cut-offs greater than or equal to (≥) 40 estimated dose giving 50% signal reduction when compared to a control without serum (ED50), as assessed by the Pseudovirion-Based Neutralization Assay \\[PBNA\\], in HIV+ subjects.\n\nBetween-group comparisons to assess superiority were performed on the TVC (by PBNA, regardless of HPV serostatus at baseline).', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the TVC for analysis of immunogenicity, which included vaccinated subjects for whom data concerning immunogenicity endpoint measures were available at Month 7.'}, {'type': 'SECONDARY', 'title': 'Number of HIV- Subjects With Any and Grade 3 Solicited Local Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-/Cervarix Group', 'description': 'HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'OG001', 'title': 'HIV-/Gardasil Group', 'description': 'HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}], 'classes': [{'title': 'Any Pain, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '127', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Pain, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any Redness, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Redness, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Swelling, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Pain, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Pain, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any Redness, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Redness, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Swelling, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Pain, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Pain, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Any Redness, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Redness, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Swelling, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Pain, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '133', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Pain, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Any Redness, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Redness, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Swelling, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Swelling, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after each vaccine dose and across doses', 'description': 'Assessed solicited local symptoms were pain, redness, swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling with a maximum diameter greater than 50 millimeters (mm).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had available symptom sheets completed.'}, {'type': 'SECONDARY', 'title': 'Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-/Cervarix Group', 'description': 'HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'OG001', 'title': 'HIV-/Gardasil Group', 'description': 'HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}], 'classes': [{'title': 'Any Arthralgia, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Arthralgia, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Arthralgia, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Any Fatigue, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fatigue, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Related Fatigue, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Any Gastrointestinal, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Gastrointestinal, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related Gastrointestinal, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Any Headache, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Headache, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Related Headache, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Any Myalgia, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Myalgia, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Related Myalgia, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Any Rash, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Rash, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Rash, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any Temperature, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Temperature, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Temperature, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Any Urticaria, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Urticaria, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Urticaria, Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Any Arthralgia, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Arthralgia, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Arthralgia, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Any Fatigue, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fatigue, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Fatigue, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Any Gastrointestinal, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Gastrointestinal, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related Gastrointestinal, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Any Headache, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Headache, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Related Headache, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Any Myalgia, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Myalgia, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Myalgia, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Any Rash, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Rash, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Rash, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any Temperature, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Temperature, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Temperature, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Any Urticaria, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Urticaria, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Urticaria, Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any Arthralgia, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Arthralgia, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Related Arthralgia, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Any Fatigue, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fatigue, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Related Fatigue, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Any Gastrointestinal, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Gastrointestinal, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Gastrointestinal, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Any Headache, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Headache, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Related Headache, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Any Myalgia, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Myalgia, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Related Myalgia, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Any Rash, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Rash, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Rash, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any Temperature, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Temperature, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related Temperature, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Any Urticaria, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Urticaria, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Urticaria, Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Any Arthralgia, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Arthralgia, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Related Arthralgia, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Any Fatigue, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Fatigue, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Related Fatigue, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'Any Gastrointestinal, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Gastrointestinal, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related Gastrointestinal, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Any Headache, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Headache, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Related Headache, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'Any Myalgia, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Myalgia, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Related Myalgia, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'Any Rash, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Rash, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Rash, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Any Temperature, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Temperature, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Related Temperature, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Any Urticaria, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 Urticaria, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related Urticaria, Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after each vaccine dose and across doses', 'description': 'Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal \\[nausea, vomiting, diarrhoea and/or abdominal pain\\], headache, myalgia, rash, temperature \\[defined as axillary temperature higher than (\\>) 37.5 degrees Celsius (°C)\\] and urticaria. Any = occurrence of the symptom regardless of intensity grade and relationship. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature \\> 39.0 °C. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Related = symptom assessed by the investigator as related to the vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had available symptom sheets completed.'}, {'type': 'SECONDARY', 'title': 'Number of HIV- Subjects With Unsolicited Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-/Cervarix Group', 'description': 'HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'OG001', 'title': 'HIV-/Gardasil Group', 'description': 'HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}], 'classes': [{'title': 'Any AE(s)', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 AE(s)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Related AE(s)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after any vaccination', 'description': 'An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 symptom = symptom that prevented normal activity. Related = symptom assessed by the investigator as related to the vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort for analysis of safety, which included all subjects with at least one vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of HIV- Subjects With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-/Cervarix Group', 'description': 'HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'OG001', 'title': 'HIV-/Gardasil Group', 'description': 'HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)', 'description': 'SAEs assessed include any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or represented a congenital anomaly/birth defect in the offspring of a study subject.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort for analysis of safety, which included all subjects with at least one vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of HIV- Subjects With Medically Significant Conditions (MSCs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-/Cervarix Group', 'description': 'HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'OG001', 'title': 'HIV-/Gardasil Group', 'description': 'HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)', 'description': 'Medically significant conditions (MSCs) are defined as AEs prompting emergency room or physician visits that were not related to common diseases, or not related to routine visits for physical examination or vaccination, SAEs that were not related to common diseases.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort for analysis of safety, which included all subjects with at least one vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of HIV- Subjects With Potential Immune-mediated Disease (pIMDs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-/Cervarix Group', 'description': 'HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'OG001', 'title': 'HIV-/Gardasil Group', 'description': 'HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)', 'description': 'Potential immune-mediated diseases are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort for analysis of safety, which included all subjects with at least one vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV+/Cervarix Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'OG001', 'title': 'HIV+/Gardasil Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'OG002', 'title': 'HIV-/Cervarix Group', 'description': 'HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'OG003', 'title': 'HIV-/Gardasil Group', 'description': 'HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}], 'classes': [{'title': 'Live infant NO apparent congenital anomaly', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'Live infant congenital anomaly', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Elective termin. NO apparent congenital anomaly', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Elective termin. congenital anomaly', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Ectopic pregnancy', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Spontaneous abortion NO apparent congen. anomaly', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Stillbirth NO apparent congenital anomaly', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Stillbirth congenital anomaly', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Lost to follow-up', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Pregnancy ongoing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the entire study period (from Day 0 up to Month 24)', 'description': 'Pregnancy related outcomes were: live infant no apparent congenital anomaly, live infant congenital anomaly, elective termination (termin.) no apparent congenital anomaly, elective termination (termin.) congenital anomaly, ectopic pregnancy, spontaneous abortion no apparent congenital (congen.) anomaly, stillbirth no apparent congenital anomaly, stillbirth congenital anomaly, lost to follow-up, pregnancy ongoing, missing.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who reported any pregnancies and outcomes of reported pregnancies.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '145', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV+/Cervarix Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'OG001', 'title': 'HIV+/Gardasil Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'OG002', 'title': 'HIV-/Cervarix Group', 'description': 'HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'OG003', 'title': 'HIV-/Gardasil Group', 'description': 'HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}], 'classes': [{'title': 'ALAT, Day 0, Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '145', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'ALAT, Week 6, Unknown', 'denoms': [{'units': 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'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'ESPH, Month 12, Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}, {'value': '118', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'ESPH, Month 18, Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '117', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'ESPH, Month 24, Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '111', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'ESPH, Day 0, Below', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '145', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'ESPH, Week 6, Below', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '137', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'ESPH, Week 10, Below', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '135', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'ESPH, Month 6, Below', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '134', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'ESPH, Month 7, Below', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}, {'value': '125', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'ESPH, Month 12, Below', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}, {'value': '118', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'ESPH, Month 18, Below', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '117', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'ESPH, Month 24, Below', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '111', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'ESPH, Day 0, Within', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '145', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '133', 'groupId': 'OG003'}]}]}, {'title': 'ESPH, Week 6, Within', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '137', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}, {'value': '126', 'groupId': 'OG003'}]}]}, {'title': 'ESPH, Week 10, Within', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '135', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}, {'value': '130', 'groupId': 'OG003'}]}]}, {'title': 'ESPH, Month 6, Within', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '134', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}, {'value': '124', 'groupId': 'OG003'}]}]}, {'title': 'ESPH, Month 7, Within', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}, {'value': '125', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '112', 'groupId': 'OG003'}]}]}, {'title': 'ESPH, Month 12, Within', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}, {'value': '118', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '107', 'groupId': 'OG003'}]}]}, {'title': 'ESPH, Month 18, Within', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '117', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '105', 'groupId': 'OG003'}]}]}, {'title': 'ESPH, Month 24, Within', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '111', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '99', 'groupId': 'OG003'}]}]}, {'title': 'ESPH, Day 0, Above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '145', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'ESPH, Week 6, Above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '137', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'ESPH, Week 10, Above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '135', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'ESPH, Month 6, Above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '134', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'ESPH, Month 7, Above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}, {'value': '125', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'ESPH, Month 12, Above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}, {'value': '118', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'ESPH, Month 18, Above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '117', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'ESPH, Month 24, Above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '111', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 0, Week 6, Week 10, Month 6, Month 7, Month 12, Month 18 and Month 24', 'description': 'Among assessed haematological and biochemical parameters were: alanine aminotransferase \\[ALAT\\], basophils \\[BSPH\\], creatinine \\[CRT\\], eosinophils \\[ESPH\\]. Unknown = value unknown for the specified visit and laboratory parameter; Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available at Day 0, Week 6, Week 10, Month 6, Month 7\\*, Month 12, Month 18 and Month 24.\n\n\\* Month 7 data for HIV+/Cervarix and HIV+/Gardasil groups are also reported in the Primary outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '145', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV+/Cervarix Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'OG001', 'title': 'HIV+/Gardasil Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'OG002', 'title': 'HIV-/Cervarix Group', 'description': 'HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'OG003', 'title': 'HIV-/Gardasil Group', 'description': 'HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}], 'classes': [{'title': 'HTCR, Day 0, Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '145', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'HTCR, Week 6, Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '137', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'HTCR, Week 10, Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '135', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'HTCR, Month 6, Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '134', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'HTCR, Month 7, Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}, {'value': '125', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'HTCR, Month 12, Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}, {'value': '118', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'HTCR, Month 18, Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '117', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'HTCR, Month 24, Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '111', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'HTCR, Day 0, Below', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '145', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}]}, {'title': 'HTCR, Week 6, Below', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '137', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}, {'title': 'HTCR, Week 10, Below', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '135', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'HTCR, Month 6, Below', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '134', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}]}, {'title': 'HTCR, Month 7, Below', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}, {'value': '125', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}]}, {'title': 'HTCR, Month 12, Below', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}, {'value': '118', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}]}, {'title': 'HTCR, Month 18, Below', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '117', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}]}, {'title': 'HTCR, Month 24, Below', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': 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[{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}, {'value': '118', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}, {'value': '113', 'groupId': 'OG003'}]}]}, {'title': 'MONO, Month 18, Within', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '117', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}, {'value': '109', 'groupId': 'OG003'}]}]}, {'title': 'MONO, Month 24, Within', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '111', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '99', 'groupId': 'OG003'}]}]}, {'title': 'MONO, Day 0, Above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '145', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'MONO, Week 6, Above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '137', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'MONO, Week 10, Above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '135', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'MONO, Month 6, Above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '134', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'MONO, Month 7, Above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}, {'value': '125', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'MONO, Month 12, Above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}, {'value': '118', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'MONO, Month 18, Above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '117', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'MONO, Month 24, Above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '111', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 0, Week 6, Week 10, Month 6, Month 7, Month 12, Month 18 and Month 24', 'description': 'Among assessed haematological parameters were: haematocrit \\[HTCR\\], haemoglobin \\[HGB\\], lymphocytes \\[LYMP\\] and monocytes \\[MONO\\]. Unknown = value unknown for the specified visit and laboratory parameter; Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available at Day 0, Week 6, Week 10, Month 6, Month 7\\*, Month 12, Month 18 and Month 24.\n\n\\* Month 7 data for HIV+/Cervarix and HIV+/Gardasil groups are also reported in the Primary outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '145', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV+/Cervarix Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'OG001', 'title': 'HIV+/Gardasil Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'OG002', 'title': 'HIV-/Cervarix Group', 'description': 'HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'OG003', 'title': 'HIV-/Gardasil Group', 'description': 'HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}], 'classes': [{'title': 'NTPH, Day 0, Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '145', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'NTPH, Week 6, Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '137', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'NTPH, Week 10, Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '135', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'NTPH, Month 6, Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '134', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'NTPH, Month 7, Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}, {'value': '125', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'NTPH, Month 12, Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}, {'value': '118', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'NTPH, Month 18, Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '117', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'NTPH, Month 24, Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '111', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'NTPH, Day 0, Below', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '145', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'NTPH, Week 6, Below', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '137', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}, {'title': 'NTPH, Week 10, Below', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '135', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}, {'title': 'NTPH, Month 6, Below', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '134', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}]}, {'title': 'NTPH, Month 7, Below', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}, {'value': '125', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'NTPH, Month 12, Below', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}, {'value': '118', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}, {'title': 'NTPH, Month 18, Below', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '117', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}]}, {'title': 'NTPH, Month 24, Below', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '111', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}, {'title': 'NTPH, Day 0, Within', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '145', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}, {'value': '122', 'groupId': 'OG003'}]}]}, {'title': 'NTPH, Week 6, Within', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '137', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}, {'value': '116', 'groupId': 'OG003'}]}]}, {'title': 'NTPH, Week 10, Within', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '135', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}, {'value': '113', 'groupId': 'OG003'}]}]}, {'title': 'NTPH, Month 6, Within', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '134', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '104', 'groupId': 'OG003'}]}]}, {'title': 'NTPH, Month 7, Within', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}, {'value': '125', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}, {'value': '106', 'groupId': 'OG003'}]}]}, {'title': 'NTPH, Month 12, Within', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}, {'value': '118', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '94', 'groupId': 'OG003'}]}]}, {'title': 'NTPH, Month 18, Within', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '117', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '92', 'groupId': 'OG003'}]}]}, {'title': 'NTPH, Month 24, Within', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '111', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}, {'value': '89', 'groupId': 'OG003'}]}]}, {'title': 'NTPH, Day 0, Above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '145', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}]}, {'title': 'NTPH, Week 6, Above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '137', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}, {'title': 'NTPH, Week 10, Above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '135', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}, {'title': 'NTPH, Month 6, Above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '134', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}]}, {'title': 'NTPH, Month 7, Above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}, {'value': '125', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}, {'title': 'NTPH, Month 12, Above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}, {'value': '118', 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{'value': '117', 'groupId': 'OG003'}]}]}, {'title': 'RBC, Month 7, Within', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}, {'value': '125', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}]}, {'title': 'RBC, Month 12, Within', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}, {'value': '118', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}]}, {'title': 'RBC, Month 18, Within', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '116', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}, {'value': '96', 'groupId': 'OG003'}]}]}, {'title': 'RBC, Month 24, Within', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '111', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}, {'value': '98', 'groupId': 'OG003'}]}]}, {'title': 'RBC, Day 0, Above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}, {'value': '141', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'RBC, Week 6, Above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'RBC, Week 10, Above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '135', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'RBC, Month 6, Above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '134', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'RBC, Month 7, Above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}, {'value': '125', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'RBC, Month 12, Above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}, {'value': '118', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'RBC, Month 18, Above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '116', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'RBC, Month 24, Above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '111', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'WBC, Day 0, Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}, {'value': '145', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'WBC, Week 6, Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'WBC, Week 10, Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'WBC, Month 6, Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '134', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'WBC, Month 7, Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}, {'value': '125', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'WBC, Month 12, Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}, {'value': '118', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'WBC, Month 18, Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}, {'value': '117', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'WBC, Month 24, Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}, {'value': '111', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'WBC, Day 0, Below', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}, {'value': '145', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'WBC, Week 6, Below', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'WBC, Week 10, Below', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'WBC, Month 6, Below', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '134', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'WBC, Month 7, Below', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}, {'value': '125', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'WBC, Month 12, Below', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}, {'value': '118', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'WBC, Month 18, Below', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}, {'value': '117', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'WBC, Month 24, Below', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}, {'value': '111', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'WBC, Day 0, Within', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}, {'value': '145', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '135', 'groupId': 'OG002'}, {'value': '140', 'groupId': 'OG003'}]}]}, {'title': 'WBC, Week 6, Within', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}, {'value': '135', 'groupId': 'OG003'}]}]}, {'title': 'WBC, Week 10, Within', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '116', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}, {'value': '129', 'groupId': 'OG003'}]}]}, {'title': 'WBC, Month 6, Within', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '134', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}, {'value': '128', 'groupId': 'OG003'}]}]}, {'title': 'WBC, Month 7, Within', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}, {'value': '125', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}, {'value': '120', 'groupId': 'OG003'}]}]}, {'title': 'WBC, Month 12, Within', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}, {'value': '118', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '115', 'groupId': 'OG003'}]}]}, {'title': 'WBC, Month 18, Within', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}, {'value': '117', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '107', 'groupId': 'OG003'}]}]}, {'title': 'WBC, Month 24, Within', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}, {'value': '111', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}, {'value': '101', 'groupId': 'OG003'}]}]}, {'title': 'WBC, Day 0, Above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}, {'value': '145', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'WBC, Week 6, Above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'WBC, Week 10, Above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'WBC, Month 6, Above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '134', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'WBC, Month 7, Above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}, {'value': '125', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'WBC, Month 12, Above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}, {'value': '118', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'WBC, Month 18, Above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}, {'value': '117', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'WBC, Month 24, Above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}, {'value': '111', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 0, Week 6, Week 10, Month 6, Month 7, Month 12, Month 18 and Month 24', 'description': 'Among assessed haematological parameters were: neutrophils \\[NTPH\\], platelets \\[PLAT\\], red blood cells \\[RBC\\] and white blood cells \\[WBC\\]. Unknown = value unknown for the specified visit and laboratory parameter; Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available at Day 0, Week 6, Week 10, Month 6, Month 7\\*, Month 12, Month 18 and Month 24.\n\n\\* Month 7 data for HIV+/Cervarix and HIV+/Gardasil groups are also reported in the Primary outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With SAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '145', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV+/Cervarix Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'OG001', 'title': 'HIV+/Gardasil Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'OG002', 'title': 'HIV-/Cervarix Group', 'description': 'HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'OG003', 'title': 'HIV-/Gardasil Group', 'description': 'HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the entire study period (from Day 0 up to Month 24)', 'description': 'SAEs assessed include any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or represented a congenital anomaly/birth defect in the offspring of a study subject.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort for analysis of safety, which included all subjects with at least one vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Medically Significant Conditions (MSCs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '145', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV+/Cervarix Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'OG001', 'title': 'HIV+/Gardasil Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'OG002', 'title': 'HIV-/Cervarix Group', 'description': 'HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'OG003', 'title': 'HIV-/Gardasil Group', 'description': 'HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 up to Month 18 (from Day 0 up to 12 months after the last vaccination dose at Month 6)', 'description': 'Medically significant conditions (MSCs) are defined as AEs prompting emergency room or physician visits that were not related to common diseases, or not related to routine visits for physical examination or vaccination, SAEs that were not related to common diseases.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort for analysis of safety, which included all subjects with at least one vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Potential Immune-mediated Diseases (pIMDs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '145', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV+/Cervarix Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'OG001', 'title': 'HIV+/Gardasil Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'OG002', 'title': 'HIV-/Cervarix Group', 'description': 'HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'OG003', 'title': 'HIV-/Gardasil Group', 'description': 'HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 up to Month 18 (from Day 0 up to 12 months after the last vaccination dose at Month 6)', 'description': 'Potential immune-mediated diseases are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort for analysis of safety, which included all subjects with at least one vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Cluster of Differentiation 4 (CD4+) Cell Count in HIV+ Subjects at Months 12, 18 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV+/Cervarix Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'OG001', 'title': 'HIV+/Gardasil Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}], 'classes': [{'title': 'CD4+ cell counts, Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '584.5', 'groupId': 'OG000', 'lowerLimit': '498.0', 'upperLimit': '832.0'}, {'value': '602.0', 'groupId': 'OG001', 'lowerLimit': '445.0', 'upperLimit': '835.0'}]}]}, {'title': 'CD4+ cell counts, Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '621.0', 'groupId': 'OG000', 'lowerLimit': '472.0', 'upperLimit': '789.0'}, {'value': '572.0', 'groupId': 'OG001', 'lowerLimit': '443.0', 'upperLimit': '770.0'}]}]}, {'title': 'CD4+ cell counts, Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '568.0', 'groupId': 'OG000', 'lowerLimit': '447.0', 'upperLimit': '738.0'}, {'value': '598.0', 'groupId': 'OG001', 'lowerLimit': '441.0', 'upperLimit': '834.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Months 12, 18 and 24', 'description': 'CD4+ cell count, expressed in cells/cubic millimeter (mm3), was assessed for HIV+ subjects.', 'unitOfMeasure': 'cells/mm3', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available at Months 12, 18 and 24.'}, {'type': 'SECONDARY', 'title': 'HIV Viral Load (VL) in HIV+ Subjects at Months 12, 18 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV+/Cervarix Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'OG001', 'title': 'HIV+/Gardasil Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}], 'classes': [{'title': 'HIV viral load, Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '3.2'}, {'value': '2.3', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '3.7'}]}]}, {'title': 'HIV viral load, Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '3.2'}, {'value': '2.2', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '3.8'}]}]}, {'title': 'HIV viral load, Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '2.8'}, {'value': '2.1', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '3.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Months 12, 18 and 24', 'description': 'HIV VL, expressed in HIV copies/milliliter (mL), was assessed for HIV+ subjects.', 'unitOfMeasure': 'HIV copies/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available at Months 12, 18 and 24.'}, {'type': 'SECONDARY', 'title': 'Number of HIV+ Subjects by WHO HIV Clinical Staging', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV+/Cervarix Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'OG001', 'title': 'HIV+/Gardasil Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}], 'classes': [{'title': 'Clinical stage 1, Month 12', 'categories': [{'measurements': [{'value': '113', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}]}, {'title': 'Clinical stage 2, Month 12', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Clinical stage 3, Month 12', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Clinical stage 4, Month 12', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Clinical stage 1, Month 18', 'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}]}, {'title': 'Clinical stage 2, Month 18', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Clinical stage 3, Month 18', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Clinical stage 4, Month 18', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Clinical stage 1, Month 24', 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}]}, {'title': 'Clinical stage 2, Month 24', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Clinical stage 3, Month 24', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Clinical stage 4, Month 24', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Months 12, 18 and 24', 'description': 'HIV+ subjects were categorised into clinical stages 1 through 4, as per the WHO classification \\[WHO, 2009\\].', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available at Months 12, 18 and 24.'}, {'type': 'SECONDARY', 'title': 'Pseudovirion-Based Neutralization Assay (PBNA) Titers of Anti-HPV-16/18 Antibodies in HIV- Subjects, Based on TVC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV-/Cervarix Group', 'description': 'HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'OG001', 'title': 'HIV-/Gardasil Group', 'description': 'HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}], 'classes': [{'title': 'Anti-HPV-16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60550.6', 'groupId': 'OG000', 'lowerLimit': '44040.1', 'upperLimit': '83250.9'}, {'value': '19634.8', 'groupId': 'OG001', 'lowerLimit': '14410.8', 'upperLimit': '26752.4'}]}]}, {'title': 'Anti-HPV-18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32118.1', 'groupId': 'OG000', 'lowerLimit': '23195.8', 'upperLimit': '44472.3'}, {'value': '5773.4', 'groupId': 'OG001', 'lowerLimit': '4205.2', 'upperLimit': '7926.4'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '5.38', 'ciLowerLimit': '3.20', 'ciUpperLimit': '9.06', 'groupDescription': 'Adjusted GMT ratio for anti-HPV-18 neutra antibody (ED50): To demonstrate that the immunogenicity of Cervarix vaccine (HIV-/Cervarix Group) was superior to that of Gardasil vaccine (HIV-/Gardasil Group), in terms of geometric mean titers (GMTs) against HPV-18, measured by Pseudovirion-based neutralization assay (PBNA) in HIV- subjects.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANOVA model on the log10 transformation of the titers for HIV- subjects and including the vaccine group as fixed effect.', 'nonInferiorityComment': 'Superiority was defined as the lower limit of the 97.5% CI for the ratio of GMTs (Cervarix over Gardasil) for HPV-18 type being above 1, with a statistically significant p-value.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '3.05', 'ciLowerLimit': '1.84', 'ciUpperLimit': '5.06', 'groupDescription': 'Adjusted GMT ratio for anti-HPV-16 neutra antibody (ED50): To demonstrate that the immunogenicity of Cervarix vaccine (HIV-/Cervarix Group) was superior to that of Gardasil vaccine (HIV-/Gardasil Group), in terms of geometric mean titers (GMTs) against HPV-16, measured by Pseudovirion-based neutralization assay (PBNA) in HIV- subjects.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANOVA model on the log10 transformation of the titers for HIV- subjects and including the vaccine group as fixed effect.', 'nonInferiorityComment': 'Superiority was defined as the lower limit of the 97.5% CI for the ratio of GMTs (Cervarix over Gardasil) for HPV-16 type being above 1, with a statistically significant p-value.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Month 7 (30 days after the last vaccination dose at Month 6)', 'description': 'Titers of anti-HPV-16/18 antibodies, expressed as Geometric Mean Titers (GMTs), with cut-offs greater than or equal to (≥) 40 estimated dose giving 50% signal reduction when compared to a control without serum (ED50), as assessed by the Pseudovirion-Based Neutralization Assay \\[PBNA\\], for HIV- subjects.\n\nBetween-group comparisons to assess superiority were performed on the TVC (by PBNA, regardless of HPV serostatus at baseline).', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the TVC for analysis of immunogenicity, which included vaccinated subjects for whom data concerning immunogenicity endpoint measures were available at Month 7.'}, {'type': 'SECONDARY', 'title': 'Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations by Enzyme-linked Immunosorbent Assay (ELISA) in Serum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '80', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HIV+/Cervarix Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'OG001', 'title': 'HIV+/Gardasil Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'OG002', 'title': 'HIV-/Cervarix Group', 'description': 'HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'OG003', 'title': 'HIV-/Gardasil Group', 'description': 'HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}], 'classes': [{'title': 'anti-HPV-16, Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '80', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '17.2', 'groupId': 'OG000', 'lowerLimit': '13.3', 'upperLimit': '22.2'}, {'value': '15.0', 'groupId': 'OG001', 'lowerLimit': '12.0', 'upperLimit': '18.9'}, {'value': '10.2', 'groupId': 'OG002', 'lowerLimit': '9.4', 'upperLimit': '11.0'}, {'value': '10.9', 'groupId': 'OG003', 'lowerLimit': '9.5', 'upperLimit': '12.5'}]}]}, {'title': 'anti-HPV-16, Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '80', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '452.9', 'groupId': 'OG000', 'lowerLimit': '302.3', 'upperLimit': '678.5'}, {'value': '280.2', 'groupId': 'OG001', 'lowerLimit': '182.5', 'upperLimit': '430.1'}, {'value': '390.6', 'groupId': 'OG002', 'lowerLimit': '298.3', 'upperLimit': '511.6'}, {'value': '303.2', 'groupId': 'OG003', 'lowerLimit': '228.0', 'upperLimit': '403.3'}]}]}, {'title': 'anti-HPV-16, Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '80', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2191.2', 'groupId': 'OG000', 'lowerLimit': '1775.7', 'upperLimit': '2704.0'}, {'value': '1565.5', 'groupId': 'OG001', 'lowerLimit': '1197.5', 'upperLimit': '2046.6'}, {'value': '4512.7', 'groupId': 'OG002', 'lowerLimit': '3771.5', 'upperLimit': '5399.7'}, {'value': '2993.2', 'groupId': 'OG003', 'lowerLimit': '2459.1', 'upperLimit': '3643.3'}]}]}, {'title': 'anti-HPV-16, Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '80', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4896.0', 'groupId': 'OG000', 'lowerLimit': '4002.2', 'upperLimit': '5989.3'}, {'value': '2145.2', 'groupId': 'OG001', 'lowerLimit': '1647.8', 'upperLimit': '2792.7'}, {'value': '15493.0', 'groupId': 'OG002', 'lowerLimit': '12537.0', 'upperLimit': '19146.0'}, {'value': '5960.9', 'groupId': 'OG003', 'lowerLimit': '5028.9', 'upperLimit': '7065.7'}]}]}, {'title': 'anti-HPV-16, Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '76', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1392.3', 'groupId': 'OG000', 'lowerLimit': '1077.5', 'upperLimit': '1799.0'}, {'value': '608.8', 'groupId': 'OG001', 'lowerLimit': '445.4', 'upperLimit': '832.1'}, {'value': '4389.3', 'groupId': 'OG002', 'lowerLimit': '3400.5', 'upperLimit': '5665.7'}, {'value': '1772.2', 'groupId': 'OG003', 'lowerLimit': '1473.3', 'upperLimit': '2131.7'}]}]}, {'title': 'anti-HPV-16, Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '861.3', 'groupId': 'OG000', 'lowerLimit': '662.3', 'upperLimit': '1119.9'}, {'value': '311.4', 'groupId': 'OG001', 'lowerLimit': '226.3', 'upperLimit': '428.4'}, {'value': '2294.1', 'groupId': 'OG002', 'lowerLimit': '1785.0', 'upperLimit': '2948.4'}, {'value': '798.0', 'groupId': 'OG003', 'lowerLimit': '646.6', 'upperLimit': '984.8'}]}]}, {'title': 'anti-HPV-16, Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '664.6', 'groupId': 'OG000', 'lowerLimit': '499.9', 'upperLimit': '883.7'}, {'value': '243.5', 'groupId': 'OG001', 'lowerLimit': '173.9', 'upperLimit': '341.0'}, {'value': '1893.6', 'groupId': 'OG002', 'lowerLimit': '1443.8', 'upperLimit': '2483.7'}, {'value': '601.9', 'groupId': 'OG003', 'lowerLimit': '481.8', 'upperLimit': '752.1'}]}]}, {'title': 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'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '23.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '1.0'}, {'value': '1.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '1.0'}, {'value': '1.0', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '1.0'}]}]}, {'title': 'CD8-d-IL-2, Anti-HPV-16, Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '1.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '1.0'}, {'value': '1.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '32.0'}, {'value': '1.0', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '1.0'}]}]}, {'title': 'CD8-d-IL-2, Anti-HPV-18, Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '26.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '1.0'}, {'value': '1.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '25.0'}, {'value': '1.0', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '1.0'}]}]}, {'title': 'CD8-d-IL-2, Anti-HPV-16, Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '23.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '17.0'}, {'value': '1.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '37.5'}, {'value': '1.0', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '1.0'}]}]}, {'title': 'CD8-d-IL-2, Anti-HPV-18, Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '1.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '1.0'}, {'value': '1.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '29.0'}, {'value': '1.0', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '1.0'}]}]}, {'title': 'CD8-d-IL-2, Anti-HPV-16, Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '27.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '1.0'}, {'value': '1.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '1.0'}, {'value': '1.0', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '1.0'}]}]}, {'title': 'CD8-d-IL-2, Anti-HPV-18, Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '48.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '1.0'}, {'value': '1.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '19.0'}, {'value': '1.0', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '1.0'}]}]}, {'title': 'CD8-d-TNFA, Anti-HPV-16, Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '10.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '35.0'}, {'value': '1.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '1.0'}, {'value': '1.0', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '29.0'}]}]}, {'title': 'CD8-d-TNFA, Anti-HPV-18, Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '50.0'}, {'value': '7.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '54.0'}, {'value': '1.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '33.0'}, {'value': '1.0', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '34.0'}]}]}, {'title': 'CD8-d-TNFA, Anti-HPV-16, Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '46.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '35.0'}, {'value': '1.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '1.0'}, {'value': '1.0', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '31.0'}]}]}, {'title': 'CD8-d-TNFA, Anti-HPV-18, Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '19.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '50.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '57.0'}, {'value': '1.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '28.0'}, {'value': '1.0', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '26.0'}]}]}, {'title': 'CD8-d-TNFA, Anti-HPV-16, Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '32.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '24.0'}, {'value': '1.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '31.0'}, {'value': '1.0', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '26.0'}]}]}, {'title': 'CD8-d-TNFA, Anti-HPV-18, Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '17.5', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '34.0'}, {'value': '14.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '61.0'}, {'value': '5.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '42.0'}, {'value': '1.0', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '34.0'}]}]}, {'title': 'CD8-d-TNFA, Anti-HPV-16, Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '34.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '41.0'}, {'value': '13.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '33.0'}, {'value': '1.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '49.0'}, {'value': '2.0', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '33.0'}]}]}, {'title': 'CD8-d-TNFA, Anti-HPV-18, Month 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '41.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '111.0'}, {'value': '26.5', 'groupId': 'OG001', 'lowerLimit': '15.0', 'upperLimit': '58.0'}, {'value': '1.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '58.0'}, {'value': '1.0', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '32.0'}]}]}, {'title': 'CD8-d-TNFA, Anti-HPV-16, Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '26.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '54.0'}, {'value': '28.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '49.0'}, {'value': '1.0', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '42.0'}]}]}, {'title': 'CD8-d-TNFA, Anti-HPV-18, Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000', 'lowerLimit': '24.0', 'upperLimit': '62.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '28.0'}, {'value': '1.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '48.0'}, {'value': '1.0', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '40.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Day 0, Week 6, Week 10, Month 7 and Month 12', 'description': 'The combinations of cytokines expressed were CD4/8-all doubles, CD4/8-d-cluster of differentiation 40 Ligand (CD40L), CD4/8-d-interferon gamma (IFNG), CD4/8-interleukin-2 (IL-2), CD4/8-d-tumour necrosis alpha (TNFA), as assessed by Intracellular cytokine staining (ICS). The assay was performed in a subset of approximately 100 subjects (50 HIV+ and 50 HIV-).', 'unitOfMeasure': 'CD4 cells/million T-cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Adapted ATP cohort for immunogenicity,which included subjects in a subset of approximately 100 subjects(50 HIV+ and 50 HIV-) who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HIV+/Cervarix Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'FG001', 'title': 'HIV+/Gardasil Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'FG002', 'title': 'HIV-/Cervarix Group', 'description': 'HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'FG003', 'title': 'HIV-/Gardasil Group', 'description': 'HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '129'}, {'groupId': 'FG001', 'numSubjects': '128'}, {'groupId': 'FG002', 'numSubjects': '144'}, {'groupId': 'FG003', 'numSubjects': '145'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '117'}, {'groupId': 'FG001', 'numSubjects': '117'}, {'groupId': 'FG002', 'numSubjects': '103'}, {'groupId': 'FG003', 'numSubjects': '111'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '41'}, {'groupId': 'FG003', 'numSubjects': '34'}]}], 'dropWithdraws': [{'type': 'Serious Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '18'}]}, {'type': 'Migrated/moved from study area', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '15'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A number of 873 subjects were enrolled, out of which 173 subjects were excluded from all statistical analysis.\n\n154 subjects were not administered any vaccine dose (146 screen failures subjects and 8 subjects that did not participate from Visit 1).', 'preAssignmentDetails': 'Screening involved: checking of inclusion/exclusion criteria, demographic data, history and physical examination, AF B sputum test and/or chest X-ray, blood sampling for HIV testing and safety, urine pregnancy testing, birth control and HIV, STI, STD counselling, checking records for concomitant medication/vaccination, subject card distribution.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}, {'value': '145', 'groupId': 'BG003'}, {'value': '546', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'HIV+/Cervarix Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'BG001', 'title': 'HIV+/Gardasil Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'BG002', 'title': 'HIV-/Cervarix Group', 'description': 'HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'BG003', 'title': 'HIV-/Gardasil Group', 'description': 'HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '20.4', 'spread': '3.4', 'groupId': 'BG000'}, {'value': '20.1', 'spread': '3.5', 'groupId': 'BG001'}, {'value': '19.3', 'spread': '3.0', 'groupId': 'BG002'}, {'value': '19.6', 'spread': '3.0', 'groupId': 'BG003'}, {'value': '19.8', 'spread': '3.2', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '129', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}, {'value': '145', 'groupId': 'BG003'}, {'value': '546', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African Heritage/African American', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}]}]}, {'title': 'Asian - Central/South Asian Heritage', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}, {'value': '173', 'groupId': 'BG004'}]}]}, {'title': 'Asian - East Asian Heritage', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}]}, {'title': 'Asian - Japanese Heritage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}, {'title': 'Asian - South East Asian Heritage', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '165', 'groupId': 'BG004'}]}]}, {'title': 'White - Arabic/North African Heritage', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '42', 'groupId': 'BG004'}]}]}, {'title': 'White - Caucasian/European Heritage', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '113', 'groupId': 'BG004'}]}]}, {'title': 'Unspecified', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 873}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2017-04-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-13', 'studyFirstSubmitDate': '2009-12-10', 'resultsFirstSubmitDate': '2017-01-13', 'studyFirstSubmitQcDate': '2009-12-10', 'lastUpdatePostDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-20', 'studyFirstPostDateStruct': {'date': '2009-12-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-01-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Human Immunodeficiency Virus Positive Subjects (HIV+) With Any and Grade 3 Solicited Local Symptoms', 'timeFrame': 'During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after each vaccine dose and across doses', 'description': 'Assessed solicited local symptoms were pain, redness, swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling with a maximum diameter greater than 50 millimeters (mm).'}, {'measure': 'Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms', 'timeFrame': 'During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after each vaccine dose and across doses', 'description': 'Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal \\[nausea, vomiting, diarrhoea and/or abdominal pain\\], headache, myalgia, rash, temperature \\[defined as axillary temperature higher than (\\>) 37.5 degrees Celsius (°C)\\] and urticaria. Any = occurrence of the symptom regardless of intensity grade and relationship. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature \\> 39.0 °C. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Related = symptom assessed by the investigator as related to the vaccination.'}, {'measure': 'Number of HIV+ Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)', 'timeFrame': 'During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after any vaccination', 'description': 'An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 symptom = symptom that prevented normal activity. Related = symptom assessed by the investigator as related to the vaccination.'}, {'measure': 'Number of HIV+ Subjects With Serious Adverse Events (SAEs)', 'timeFrame': 'From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)', 'description': 'SAEs assessed include any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or represented a congenital anomaly/birth defect in the offspring of a study subject.'}, {'measure': 'Number of HIV+ Subjects With Medically Significant Conditions (MSCs)', 'timeFrame': 'From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)', 'description': 'Medically significant conditions (MSCs) are defined as AEs prompting emergency room or physician visits that were not related to common diseases, or not related to routine visits for physical examination or vaccination, SAEs that were not related to common diseases.'}, {'measure': 'Number of HIV+ Subjects With Potential Immune-mediated Diseases (pIMDs)', 'timeFrame': 'From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)', 'description': 'Potential immune-mediated diseases are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.'}, {'measure': 'Number of HIV+ Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies', 'timeFrame': 'From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)', 'description': 'Pregnancy related outcomes were: live infant no apparent congenital anomaly, live infant congenital anomaly, elective termination (termin.) no apparent congenital anomaly, elective termination (termin.) congenital anomaly, ectopic pregnancy, spontaneous abortion no apparent congenital (congen.) anomaly, stillbirth no apparent congenital anomaly, stillbirth congenital anomaly, lost to follow-up, pregnancy ongoing, missing.'}, {'measure': 'Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities', 'timeFrame': 'At Month 7 (30 days after the last vaccination dose at Month 6)', 'description': 'Among assessed haematological and biochemical parameters were: alanine aminotransferase \\[ALAT\\], basophilis \\[BSPH\\], creatinine \\[CRT\\], eosinophils \\[ESPH\\], haematocrit \\[HTCR\\], haemoglobin \\[HGB\\], lymphocytes \\[LYMP\\], monocytes \\[MONO\\], neutrophils \\[NTPH\\], platelets \\[PLAT\\], red blood cells \\[RBC\\] and white blood cells \\[WBC\\]. Unknown = value unknown for the specified visit and laboratory parameter; Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.'}, {'measure': 'Cluster of Differentiation 4 (CD4+) Cell Count in HIV+ Subjects at Month 7', 'timeFrame': 'At Month 7 (30 days after the last vaccination dose at Month 6)', 'description': 'CD4+ cell count, expressed in cells/cubic millimeter (mm3), was assessed for HIV+ subjects.'}, {'measure': 'HIV Viral Load (VL) in HIV+ Subjects at Month 7', 'timeFrame': 'At Month 7 (30 days after the last vaccination dose at Month 6)', 'description': 'HIV VL, expressed in HIV copies/milliliter (mL), was assessed for HIV+ subjects.'}, {'measure': 'Number of HIV+ Subjects by World Health Organization (WHO) HIV Clinical Staging', 'timeFrame': 'At Month 7 (30 days after the last vaccination dose at Month 6)', 'description': 'HIV+ subjects were categorised into clinical stages 1 through 4, as per the WHO classification \\[WHO, 2009\\].'}, {'measure': 'Pseudovirion-Based Neutralization Assay (PBNA) Titers of Anti-HPV-16/18 Antibodies in HIV+ Subjects, Based on Adapted According-to-protocol (ATP) Cohort for Immunogenicity', 'timeFrame': 'At Month 7 (30 days after the last vaccination dose at Month 6)', 'description': 'Titers of anti-HPV-16/18 antibodies, expressed as Geometric Mean Titers (GMTs), with cut-offs greater than or equal to (≥) 40 estimated dose giving 50% signal reduction when compared to a control without serum (ED50), as assessed by the Pseudovirion-Based Neutralization Assay \\[PBNA\\], in HIV+ subjects.\n\nBetween-group comparisons to assess non-inferiority were performed on the ATP cohort for immunogenicity (by PBNA, regardless of HPV serostatus at baseline).'}, {'measure': 'Pseudovirion-Based Neutralization Assay (PBNA) Titers of Anti-HPV-16/18 Antibodies in HIV+ Subjects, Based on Total Vaccinated Cohort (TVC)', 'timeFrame': 'At Month 7 (30 days after the last vaccination dose at Month 6)', 'description': 'Titers of anti-HPV-16/18 antibodies, expressed as Geometric Mean Titers (GMTs), with cut-offs greater than or equal to (≥) 40 estimated dose giving 50% signal reduction when compared to a control without serum (ED50), as assessed by the Pseudovirion-Based Neutralization Assay \\[PBNA\\], in HIV+ subjects.\n\nBetween-group comparisons to assess superiority were performed on the TVC (by PBNA, regardless of HPV serostatus at baseline).'}], 'secondaryOutcomes': [{'measure': 'Number of HIV- Subjects With Any and Grade 3 Solicited Local Symptoms', 'timeFrame': 'During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after each vaccine dose and across doses', 'description': 'Assessed solicited local symptoms were pain, redness, swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling with a maximum diameter greater than 50 millimeters (mm).'}, {'measure': 'Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms', 'timeFrame': 'During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after each vaccine dose and across doses', 'description': 'Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal \\[nausea, vomiting, diarrhoea and/or abdominal pain\\], headache, myalgia, rash, temperature \\[defined as axillary temperature higher than (\\>) 37.5 degrees Celsius (°C)\\] and urticaria. Any = occurrence of the symptom regardless of intensity grade and relationship. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature \\> 39.0 °C. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Related = symptom assessed by the investigator as related to the vaccination.'}, {'measure': 'Number of HIV- Subjects With Unsolicited Adverse Events (AEs)', 'timeFrame': 'During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after any vaccination', 'description': 'An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 symptom = symptom that prevented normal activity. Related = symptom assessed by the investigator as related to the vaccination.'}, {'measure': 'Number of HIV- Subjects With Serious Adverse Events (SAEs)', 'timeFrame': 'From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)', 'description': 'SAEs assessed include any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or represented a congenital anomaly/birth defect in the offspring of a study subject.'}, {'measure': 'Number of HIV- Subjects With Medically Significant Conditions (MSCs)', 'timeFrame': 'From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)', 'description': 'Medically significant conditions (MSCs) are defined as AEs prompting emergency room or physician visits that were not related to common diseases, or not related to routine visits for physical examination or vaccination, SAEs that were not related to common diseases.'}, {'measure': 'Number of HIV- Subjects With Potential Immune-mediated Disease (pIMDs)', 'timeFrame': 'From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)', 'description': 'Potential immune-mediated diseases are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.'}, {'measure': 'Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies', 'timeFrame': 'During the entire study period (from Day 0 up to Month 24)', 'description': 'Pregnancy related outcomes were: live infant no apparent congenital anomaly, live infant congenital anomaly, elective termination (termin.) no apparent congenital anomaly, elective termination (termin.) congenital anomaly, ectopic pregnancy, spontaneous abortion no apparent congenital (congen.) anomaly, stillbirth no apparent congenital anomaly, stillbirth congenital anomaly, lost to follow-up, pregnancy ongoing, missing.'}, {'measure': 'Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters', 'timeFrame': 'At Day 0, Week 6, Week 10, Month 6, Month 7, Month 12, Month 18 and Month 24', 'description': 'Among assessed haematological and biochemical parameters were: alanine aminotransferase \\[ALAT\\], basophils \\[BSPH\\], creatinine \\[CRT\\], eosinophils \\[ESPH\\]. Unknown = value unknown for the specified visit and laboratory parameter; Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.'}, {'measure': 'Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters', 'timeFrame': 'At Day 0, Week 6, Week 10, Month 6, Month 7, Month 12, Month 18 and Month 24', 'description': 'Among assessed haematological parameters were: haematocrit \\[HTCR\\], haemoglobin \\[HGB\\], lymphocytes \\[LYMP\\] and monocytes \\[MONO\\]. Unknown = value unknown for the specified visit and laboratory parameter; Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.'}, {'measure': 'Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters', 'timeFrame': 'At Day 0, Week 6, Week 10, Month 6, Month 7, Month 12, Month 18 and Month 24', 'description': 'Among assessed haematological parameters were: neutrophils \\[NTPH\\], platelets \\[PLAT\\], red blood cells \\[RBC\\] and white blood cells \\[WBC\\]. Unknown = value unknown for the specified visit and laboratory parameter; Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.'}, {'measure': 'Number of Subjects With SAEs', 'timeFrame': 'During the entire study period (from Day 0 up to Month 24)', 'description': 'SAEs assessed include any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or represented a congenital anomaly/birth defect in the offspring of a study subject.'}, {'measure': 'Number of Subjects With Medically Significant Conditions (MSCs)', 'timeFrame': 'From Day 0 up to Month 18 (from Day 0 up to 12 months after the last vaccination dose at Month 6)', 'description': 'Medically significant conditions (MSCs) are defined as AEs prompting emergency room or physician visits that were not related to common diseases, or not related to routine visits for physical examination or vaccination, SAEs that were not related to common diseases.'}, {'measure': 'Number of Subjects With Potential Immune-mediated Diseases (pIMDs)', 'timeFrame': 'From Day 0 up to Month 18 (from Day 0 up to 12 months after the last vaccination dose at Month 6)', 'description': 'Potential immune-mediated diseases are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.'}, {'measure': 'Cluster of Differentiation 4 (CD4+) Cell Count in HIV+ Subjects at Months 12, 18 and 24', 'timeFrame': 'At Months 12, 18 and 24', 'description': 'CD4+ cell count, expressed in cells/cubic millimeter (mm3), was assessed for HIV+ subjects.'}, {'measure': 'HIV Viral Load (VL) in HIV+ Subjects at Months 12, 18 and 24', 'timeFrame': 'At Months 12, 18 and 24', 'description': 'HIV VL, expressed in HIV copies/milliliter (mL), was assessed for HIV+ subjects.'}, {'measure': 'Number of HIV+ Subjects by WHO HIV Clinical Staging', 'timeFrame': 'At Months 12, 18 and 24', 'description': 'HIV+ subjects were categorised into clinical stages 1 through 4, as per the WHO classification \\[WHO, 2009\\].'}, {'measure': 'Pseudovirion-Based Neutralization Assay (PBNA) Titers of Anti-HPV-16/18 Antibodies in HIV- Subjects, Based on TVC', 'timeFrame': 'At Month 7 (30 days after the last vaccination dose at Month 6)', 'description': 'Titers of anti-HPV-16/18 antibodies, expressed as Geometric Mean Titers (GMTs), with cut-offs greater than or equal to (≥) 40 estimated dose giving 50% signal reduction when compared to a control without serum (ED50), as assessed by the Pseudovirion-Based Neutralization Assay \\[PBNA\\], for HIV- subjects.\n\nBetween-group comparisons to assess superiority were performed on the TVC (by PBNA, regardless of HPV serostatus at baseline).'}, {'measure': 'Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations by Enzyme-linked Immunosorbent Assay (ELISA) in Serum', 'timeFrame': 'At Day 0, Week 6, Week 10, Month 7, Month 12, Month 18 and Month 24', 'description': 'Anti-HPV-16 and anti-HPV-18 antibody concentrations in serum, are presented as Geometric Mean Concentrations (GMCs), with cut-offs greater than or equal to (≥) 19 ELISA units per milliliter (EU/mL) and 18 EU/mL respectively, as assessed by Enzyme-linked immunosorbent assay (ELISA), in all (HIV+ and HIV-) subjects.'}, {'measure': 'Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations by ELISA in Cervicovaginal Secretion (CVS)', 'timeFrame': 'At Day 0, Week 6, Week 10, Month 7, Month 12, Month 18 and Month 24', 'description': 'Anti-HPV-16 and anti-HPV-18 antibody concentrations in CVS, are presented as Geometric Mean Concentrations (GMCs), with cut-offs greater than or equal to (≥) 0 EU/mL, as assessed by ELISA, in post-menarcheal subjects who volunteered for this procedure.'}, {'measure': 'Frequency of Specific B-cells for HPV-16/18 Antigens', 'timeFrame': 'At Day 0, Week 6, Week 10, Month 7 and Month 12', 'description': 'B-cell memory was assessed by Enzyme Linked Immuno Spot (ELISPOT) assay. The assay was performed in a subset of approximately 100 subjects (50 HIV+ and 50 HIV-).'}, {'measure': 'Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response', 'timeFrame': 'At Day 0, Week 6, Week 10, Month 7 and Month 12', 'description': 'The combinations of cytokines expressed were CD4/8-all doubles, CD4/8-d-cluster of differentiation 40 Ligand (CD40L), CD4/8-d-interferon gamma (IFNG), CD4/8-interleukin-2 (IL-2), CD4/8-d-tumour necrosis alpha (TNFA), as assessed by Intracellular cytokine staining (ICS). The assay was performed in a subset of approximately 100 subjects (50 HIV+ and 50 HIV-).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False}, 'conditionsModule': {'keywords': ['Cervarix', 'Gardasil', 'Immunogenicity', 'Cervical cancer', 'Safety', 'HPV vaccine'], 'conditions': ['Infections, Papillomavirus', 'Papillomavirus Vaccines']}, 'referencesModule': {'references': [{'pmid': '32639485', 'type': 'BACKGROUND', 'citation': 'Folschweiller N, Teixeira J, Joshi S, Goldani LZ, Supparatpinyo K, Basu P, Chotpitayasunondh T, Chetchotisakd P, Ruxrungtham K, Roteli-Martins C, Grinsztejn B, Quintana SM, Kumarasamy N, Poongulali S, Kulkarni V, Lin L, Datta SK, Descamps D, Dodet M, Dubin G, Friel D, Hezareh M, Karkada N, Meric Camilleri D, Poncelet S, Salaun B, Tavares-da-Silva F, Thomas-Jooris F, Struyf F. Immunogenicity and safety of the AS04-HPV-16/18 and HPV-6/11/16/18 human papillomavirus vaccines in asymptomatic young women living with HIV aged 15-25 years: A phase IV randomized comparative study. EClinicalMedicine. 2020 May 25;23:100353. doi: 10.1016/j.eclinm.2020.100353. eCollection 2020 Jun.'}]}, 'descriptionModule': {'briefSummary': "Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. This Phase IV, observer-blind study is designed to evaluate the safety and immunogenicity of Cervarix in HIV infected females aged 15 to 25 years as compared to Merck's HPV vaccine (Gardasil). For comparative purposes, a group of HIV negative females will also be evaluated. All subjects will receive the HPV vaccine (either Cervarix or Gardasil) according to a three-dose schedule (Day 0, Week 6, Month 6)."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects who the investigator believes that they and/or their parent(s)/legally acceptable representative(s) (LAR) can and will comply with the requirements of the protocol.\n* A female between, and including, 15 and 25 years of age at the time of the first vaccination.\n* Written informed consent obtained from the subject and/or from the subject's parent or LAR.\n* Subjects willing to undergo HIV Voluntary Counseling and Testing (VCT) and willing to be informed of their HIV infection status.\n* For HIV seropositive subjects:\n\n * Subjects must be HIV seropositive according to World Health Organization (WHO) case definition.\n * Subject must be asymptomatic (or only have persistent generalized lymphadenopathy).\n * Subjects should have a CD4 cell count \\> 350 cells/mm3.\n * If currently taking antiretrovirals (ARVs), subjects must be on compliant to triple therapy (highly active ART) and have undetectable viral load on two previous clinical visits within the six months prior to study entry.\n* For HIV seronegative subjects:\n\n * Subjects confirmed as HIV seronegative at the screening visit.\n* For non-virgin female subjects:\n\n * Subjects must have no history of abnormal cytology or CIN 1/2/3.\n * Subjects must have had no more than six life-time sexual partners prior to enrollment.\n* Subjects must have no history of congenital malformations of the uterine cervix, or history of cauterization or surgical procedures involving damage to the transformation zone of the cervix or stenosis.\n* Female subjects of non-childbearing potential may be enrolled in the study.\n* Female subjects of childbearing potential may be enrolled in the study, if the subject:\n\n * has practiced adequate contraception for 30 days prior to vaccination, and\n * has a negative pregnancy test at screening and on the day of vaccination, and\n * has agreed to continue adequate contraception during the entire treatment period and for two months after completion of the vaccination series.\n\nExclusion Criteria:\n\n* Previous vaccination against HPV, or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period (Day 0 to Month 24).\n* ART not compliant with the National Guidelines.\n* Active tuberculosis (TB) visit (criteria mandatory only for HIV+ subjects).\n* Current TB therapy.\n* Hemoglobin \\< 8.0 g/dL at the screening visit.\n* Creatinine \\> 1.5-fold the upper limit of normal (ULN) at the screening visit.\n* Alanine aminotransferase (ALT) \\> 2.5-fold ULN at the screening visit.\n* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period (Day 0 to Month 24).\n* Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs (with the exception of ART) within six months prior to the first vaccine dose.\n* Administration of a vaccine not foreseen by the study protocol within 30 days (Days 0 - 29) before the first dose of study vaccine/control. Enrollment will be postponed until the subject is outside the specified window.\n* Planned administration of a vaccine not foreseen by the study protocol within 30 days before or 30 days after (i.e., Days 0 - 29) any dose of study vaccine.\n* Previous administration of components of the investigational vaccine.\n* Cancer or autoimmune disease under treatment.\n* Hypersensitivity to latex.\n* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine/control.\n* Acute disease and/or fever at the time of enrollment.\n* Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory testing performed at the screening visit.\n* History of any neurological disorders or seizures.\n* Pregnant or breastfeeding female.\n* A subject planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the study period, up to two months after the last vaccine dose (i.e., up to Month 8).\n* Concurrently participating in another clinical study, at any time during the study period (Day 0 to Month 24), in which the subject has been or will be exposed to an investigational or a non-investigational product.\n* Any medically diagnosed or suspected immunodeficient condition (other than HIV for HIV seropositive subjects), based on medical history, physical examination and/or laboratory tests results.\n* Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine/control or planned administration during the study period. Enrollment will be postponed until the subject is outside the specified window.\n* Administration of trimethoprim/sulphamethoxazole within seven days before the first dose of study vaccine/control, or planned administration of trimethoprim/sulphamethoxazole within seven days after the first dose of study vaccine/control.\n* Current drugs or alcohol abuse.\n* Child in care."}, 'identificationModule': {'nctId': 'NCT01031069', 'briefTitle': 'Evaluation of Safety and Immunogenicity of a Human Papillomavirus (HPV) Vaccine in Human Immunodeficiency Virus (HIV) Infected Females', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Safety and Immunogenicity of Cervarix™ in Human Immunodeficiency Virus Infected Females', 'orgStudyIdInfo': {'id': '109823'}, 'secondaryIdInfos': [{'id': '2013-003429-28', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HIV+/Cervarix Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.', 'interventionNames': ["Biological: GSK Biologicals' HPV vaccine 580299"]}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HIV+/Gardasil Group', 'description': 'HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.', 'interventionNames': ["Biological: Merck's Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine (Gardasil)"]}, {'type': 'EXPERIMENTAL', 'label': 'HIV-/Cervarix Group', 'description': 'HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.', 'interventionNames': ["Biological: GSK Biologicals' HPV vaccine 580299"]}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HIV-/Gardasil Group', 'description': 'HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.', 'interventionNames': ["Biological: Merck's Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine (Gardasil)"]}], 'interventions': [{'name': "GSK Biologicals' HPV vaccine 580299", 'type': 'BIOLOGICAL', 'otherNames': ['Cervarix'], 'description': 'Subjects received three doses of the study vaccine administered intramuscularly according to a Day 0, Week 6, and Month 6 vaccination schedule.', 'armGroupLabels': ['HIV+/Cervarix Group', 'HIV-/Cervarix Group']}, {'name': "Merck's Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine (Gardasil)", 'type': 'BIOLOGICAL', 'otherNames': ['Gardasil'], 'description': 'Subjects received three doses of the study vaccine administered intramuscularly according to a Day 0, Week 6, and Month 6 vaccination schedule.', 'armGroupLabels': ['HIV+/Gardasil Group', 'HIV-/Gardasil Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90035003', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '14049-900', 'city': 'Ribeirão Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}, {'zip': '13083-970', 'city': 'Campinas', 'country': 'Brazil', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -22.90556, 'lon': -47.06083}}, {'zip': '21040-360', 'city': 'Rio 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