Ignite Creation Date:
2025-12-24 @ 10:17 PM
Ignite Modification Date:
2025-12-27 @ 5:41 PM
Study NCT ID:
NCT00963235
Status:
COMPLETED
Last Update Posted:
2013-06-10
First Post:
2009-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety & Immunogenicity of 13vPnC in HIV-Infected Subjects Aged 18 or Older Who Were Previously Immunized With 23vPS
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D011008', 'term': 'Pneumococcal Infections'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D013290', 'term': 'Streptococcal Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)', 'description': 'SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.', 'eventGroups': [{'id': 'EG000', 'title': '13vPnC (After Dose 1 and Before Dose 2)', 'description': 'Participants who were previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS), received 1 dose of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and were assessed from 13vPnC Dose 1 to prior to administration of 13vPnC Dose 2.', 'otherNumAtRisk': 329, 'otherNumAffected': 244, 'seriousNumAtRisk': 329, 'seriousNumAffected': 24}, {'id': 'EG001', 'title': '13vPnC (After Dose 2 and Before Dose 3)', 'description': 'Participants who were previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS), received 2 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 6 months apart and were assessed from 13vPnC Dose 2 prior to administration of 13vPnC Dose 3.', 'otherNumAtRisk': 300, 'otherNumAffected': 196, 'seriousNumAtRisk': 300, 'seriousNumAffected': 14}, {'id': 'EG002', 'title': '13vPnC (After Dose 3 and Before Dose 3 Blood Draw)', 'description': 'Participants who were previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS), received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 6 months apart and were assessed from 13vPnC Dose 3 to prior to the blood draw 28 to 42 days post-13vPnC Dose 3.', 'otherNumAtRisk': 278, 'otherNumAffected': 169, 'seriousNumAtRisk': 278, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': '13vPnC (After Dose 3 Blood Draw)', 'description': 'Participants who were previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS), received at least 1 of the 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 6 months apart and were assessed from the blood draw 28 to 42 days post-13vPnC Dose 3 up to 6-month follow-up.', 'otherNumAtRisk': 329, 'otherNumAffected': 30, 'seriousNumAtRisk': 329, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Polycythaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Microcytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Deafness neurosensory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cerumen impaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Deafness unilateral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Eustachian tube disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Episcleritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Iritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Anal fissure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Tongue haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Anogenital dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gingival swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, 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329, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Peripheral vascular disorder', 'stats': 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{'term': 'Swelling (Any)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Swelling (Mild)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 125, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Swelling (Moderate)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Swelling (Severe)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Pain (Any)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 260, 'numAffected': 205}, {'groupId': 'EG001', 'numAtRisk': 237, 'numAffected': 193}, {'groupId': 'EG002', 'numAtRisk': 204, 'numAffected': 167}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Pain (Mild)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 258, 'numAffected': 197}, {'groupId': 'EG001', 'numAtRisk': 230, 'numAffected': 181}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 158}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Pain (Moderate)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 50}, {'groupId': 'EG002', 'numAtRisk': 129, 'numAffected': 39}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Pain (Severe)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 123, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 105, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Local Reactions'}, {'term': 'Fever (>=38 degrees C)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 104, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Fever (>=38 but <38.5 degrees C)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 104, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Fever (>=38.5 but <39 degrees C)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 157, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Fever (>=39 but =<40 degrees C)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Fever (>40 degrees C)', 'notes': 'Report of fever \\>40 degrees C after 13vPnC Dose 1 was confirmed as data entry error.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Fatigue (Any)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 141}, {'groupId': 'EG001', 'numAtRisk': 188, 'numAffected': 119}, {'groupId': 'EG002', 'numAtRisk': 160, 'numAffected': 90}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Fatigue (Mild)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 121}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 101}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 72}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Fatigue (Moderate)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 75}, {'groupId': 'EG001', 'numAtRisk': 154, 'numAffected': 59}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 48}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Fatigue (Severe)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 121, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 105, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Headache (Any)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numAffected': 138}, {'groupId': 'EG001', 'numAtRisk': 173, 'numAffected': 97}, {'groupId': 'EG002', 'numAtRisk': 137, 'numAffected': 64}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Headache (Mild)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 216, 'numAffected': 124}, {'groupId': 'EG001', 'numAtRisk': 165, 'numAffected': 80}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 53}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Headache (Moderate)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 44}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 29}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Headache (Severe)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 103, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Vomiting (Any)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Vomiting (Mild)', 'stats': [{'groupId': 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0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Diarrhea (Any)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 69}, {'groupId': 'EG002', 'numAtRisk': 134, 'numAffected': 52}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Diarrhea (Mild)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 58}, {'groupId': 'EG002', 'numAtRisk': 131, 'numAffected': 47}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Diarrhea (Moderate)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 109, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'Diarrhea (Severe)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 103, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Systemic Events'}, {'term': 'New generalized muscle pain (Any)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 234, 'numAffected': 152}, {'groupId': 'EG001', 'numAtRisk': 199, 'numAffected': 143}, {'groupId': 'EG002', 'numAtRisk': 170, 'numAffected': 112}, {'groupId': 'EG003', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 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278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 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stage unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Complicated migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 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'MedDRA 15.0'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Substance abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 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{'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Menometrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 278, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 329, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.'}], 'classes': [{'title': 'Serotype 1', 'categories': [{'measurements': [{'value': '0.94', 'groupId': 'OG000', 'lowerLimit': '0.88', 'upperLimit': '1.01'}]}]}, {'title': 'Serotype 3', 'categories': [{'measurements': [{'value': '1.01', 'groupId': 'OG000', 'lowerLimit': '0.95', 'upperLimit': '1.08'}]}]}, {'title': 'Serotype 4', 'categories': [{'measurements': [{'value': '1.01', 'groupId': 'OG000', 'lowerLimit': '0.94', 'upperLimit': '1.08'}]}]}, {'title': 'Serotype 5', 'categories': [{'measurements': [{'value': '0.99', 'groupId': 'OG000', 'lowerLimit': '0.94', 'upperLimit': '1.05'}]}]}, {'title': 'Serotype 6A', 'categories': [{'measurements': [{'value': '1.19', 'groupId': 'OG000', 'lowerLimit': '1.11', 'upperLimit': '1.27'}]}]}, {'title': 'Serotype 6B', 'categories': [{'measurements': [{'value': '1.21', 'groupId': 'OG000', 'lowerLimit': '1.13', 'upperLimit': '1.31'}]}]}, {'title': 'Serotype 7F', 'categories': [{'measurements': [{'value': '1.07', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '1.14'}]}]}, {'title': 'Serotype 9V', 'categories': [{'measurements': [{'value': '1.08', 'groupId': 'OG000', 'lowerLimit': '1.02', 'upperLimit': '1.15'}]}]}, {'title': 'Serotype 14', 'categories': [{'measurements': [{'value': '1.08', 'groupId': 'OG000', 'lowerLimit': '0.99', 'upperLimit': '1.17'}]}]}, {'title': 'Serotype 18C', 'categories': [{'measurements': [{'value': '1.09', 'groupId': 'OG000', 'lowerLimit': '1.02', 'upperLimit': '1.16'}]}]}, {'title': 'Serotype 19A', 'categories': [{'measurements': [{'value': '1.03', 'groupId': 'OG000', 'lowerLimit': '0.98', 'upperLimit': '1.09'}]}]}, {'title': 'Serotype 19F', 'categories': [{'measurements': [{'value': '1.17', 'groupId': 'OG000', 'lowerLimit': '1.08', 'upperLimit': '1.27'}]}]}, {'title': 'Serotype 23F', 'categories': [{'measurements': [{'value': '1.25', 'groupId': 'OG000', 'lowerLimit': '1.15', 'upperLimit': '1.37'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month post-dose 2, 1 month post-dose 3', 'description': 'Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month post-dose 2 to 1 month post-dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.', 'unitOfMeasure': 'fold rise', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population: eligible participants who were \\>=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.'}], 'classes': [{'title': 'Serotype 1: Dose 2', 'categories': [{'measurements': [{'value': '2.31', 'groupId': 'OG000', 'lowerLimit': '1.97', 'upperLimit': '2.72'}]}]}, {'title': 'Serotype 1: Dose 3', 'categories': [{'measurements': [{'value': '2.18', 'groupId': 'OG000', 'lowerLimit': '1.88', 'upperLimit': '2.54'}]}]}, {'title': 'Serotype 3: Dose 2', 'categories': [{'measurements': [{'value': '0.54', 'groupId': 'OG000', 'lowerLimit': '0.47', 'upperLimit': '0.62'}]}]}, {'title': 'Serotype 3: Dose 3', 'categories': [{'measurements': [{'value': '0.55', 'groupId': 'OG000', 'lowerLimit': '0.47', 'upperLimit': '0.63'}]}]}, {'title': 'Serotype 4: Dose 2', 'categories': [{'measurements': [{'value': '1.62', 'groupId': 'OG000', 'lowerLimit': '1.41', 'upperLimit': '1.87'}]}]}, {'title': 'Serotype 4: Dose 3', 'categories': [{'measurements': [{'value': '1.63', 'groupId': 'OG000', 'lowerLimit': '1.42', 'upperLimit': '1.88'}]}]}, {'title': 'Serotype 5: Dose 2', 'categories': [{'measurements': [{'value': '3.26', 'groupId': 'OG000', 'lowerLimit': '2.79', 'upperLimit': '3.80'}]}]}, {'title': 'Serotype 5: Dose 3', 'categories': [{'measurements': [{'value': '3.23', 'groupId': 'OG000', 'lowerLimit': '2.78', 'upperLimit': '3.75'}]}]}, {'title': 'Serotype 6A: Dose 2', 'categories': [{'measurements': [{'value': '3.86', 'groupId': 'OG000', 'lowerLimit': '3.20', 'upperLimit': '4.66'}]}]}, {'title': 'Serotype 6A: Dose 3', 'categories': [{'measurements': [{'value': '4.60', 'groupId': 'OG000', 'lowerLimit': '3.85', 'upperLimit': '5.50'}]}]}, {'title': 'Serotype 6B: Dose 2', 'categories': [{'measurements': [{'value': '4.49', 'groupId': 'OG000', 'lowerLimit': '3.70', 'upperLimit': '5.46'}]}]}, {'title': 'Serotype 6B: Dose 3', 'categories': [{'measurements': [{'value': '5.45', 'groupId': 'OG000', 'lowerLimit': '4.53', 'upperLimit': '6.57'}]}]}, {'title': 'Serotype 7F: Dose 2', 'categories': [{'measurements': [{'value': '3.40', 'groupId': 'OG000', 'lowerLimit': '2.95', 'upperLimit': '3.92'}]}]}, {'title': 'Serotype 7F: Dose 3', 'categories': [{'measurements': [{'value': '3.62', 'groupId': 'OG000', 'lowerLimit': '3.17', 'upperLimit': '4.14'}]}]}, {'title': 'Serotype 9V: Dose 2', 'categories': [{'measurements': [{'value': '2.95', 'groupId': 'OG000', 'lowerLimit': '2.56', 'upperLimit': '3.41'}]}]}, {'title': 'Serotype 9V: Dose 3', 'categories': [{'measurements': [{'value': '3.20', 'groupId': 'OG000', 'lowerLimit': '2.79', 'upperLimit': '3.66'}]}]}, {'title': 'Serotype 14: Dose 2', 'categories': [{'measurements': [{'value': '7.57', 'groupId': 'OG000', 'lowerLimit': '6.27', 'upperLimit': '9.15'}]}]}, {'title': 'Serotype 14: Dose 3', 'categories': [{'measurements': [{'value': '8.16', 'groupId': 'OG000', 'lowerLimit': '6.87', 'upperLimit': '9.69'}]}]}, {'title': 'Serotype 18C: Dose 2', 'categories': [{'measurements': [{'value': '2.75', 'groupId': 'OG000', 'lowerLimit': '2.33', 'upperLimit': '3.24'}]}]}, {'title': 'Serotype 18C: Dose 3', 'categories': [{'measurements': [{'value': '2.99', 'groupId': 'OG000', 'lowerLimit': '2.56', 'upperLimit': '3.50'}]}]}, {'title': 'Serotype 19A: Dose 2', 'categories': [{'measurements': [{'value': '7.57', 'groupId': 'OG000', 'lowerLimit': '6.54', 'upperLimit': '8.76'}]}]}, {'title': 'Serotype 19A: Dose 3', 'categories': [{'measurements': [{'value': '7.80', 'groupId': 'OG000', 'lowerLimit': '6.82', 'upperLimit': '8.93'}]}]}, {'title': 'Serotype 19F: Dose 2', 'categories': [{'measurements': [{'value': '5.73', 'groupId': 'OG000', 'lowerLimit': '4.73', 'upperLimit': '6.95'}]}]}, {'title': 'Serotype 19F: Dose 3', 'categories': [{'measurements': [{'value': '6.70', 'groupId': 'OG000', 'lowerLimit': '5.61', 'upperLimit': '8.01'}]}]}, {'title': 'Serotype 23F: Dose 2', 'categories': [{'measurements': [{'value': '3.80', 'groupId': 'OG000', 'lowerLimit': '3.17', 'upperLimit': '4.57'}]}]}, {'title': 'Serotype 23F: Dose 3', 'categories': [{'measurements': [{'value': '4.77', 'groupId': 'OG000', 'lowerLimit': '4.01', 'upperLimit': '5.67'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month post-dose 2, 1 month post-dose 3', 'description': 'Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means (GMs) were calculated using all participants with available data for both post-dose 2 and post-dose 3 blood draws.', 'unitOfMeasure': 'microgram per milliliter (mcg/mL)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population: eligible participants who were \\>=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.'}], 'classes': [{'title': 'Serotype 1: Dose 1', 'categories': [{'measurements': [{'value': '2.15', 'groupId': 'OG000', 'lowerLimit': '1.80', 'upperLimit': '2.57'}]}]}, {'title': 'Serotype 1: Dose 2', 'categories': [{'measurements': [{'value': '2.36', 'groupId': 'OG000', 'lowerLimit': '2.03', 'upperLimit': '2.75'}]}]}, {'title': 'Serotype 3: Dose 1', 'categories': [{'measurements': [{'value': '0.48', 'groupId': 'OG000', 'lowerLimit': '0.41', 'upperLimit': '0.56'}]}]}, {'title': 'Serotype 3: Dose 2', 'categories': [{'measurements': [{'value': '0.57', 'groupId': 'OG000', 'lowerLimit': '0.49', 'upperLimit': '0.65'}]}]}, {'title': 'Serotype 4: Dose 1', 'categories': [{'measurements': [{'value': '1.37', 'groupId': 'OG000', 'lowerLimit': '1.15', 'upperLimit': '1.64'}]}]}, {'title': 'Serotype 4: Dose 2', 'categories': [{'measurements': [{'value': '1.64', 'groupId': 'OG000', 'lowerLimit': '1.43', 'upperLimit': '1.89'}]}]}, {'title': 'Serotype 5: Dose 1', 'categories': [{'measurements': [{'value': '2.90', 'groupId': 'OG000', 'lowerLimit': '2.48', 'upperLimit': '3.40'}]}]}, {'title': 'Serotype 5: Dose 2', 'categories': [{'measurements': [{'value': '3.29', 'groupId': 'OG000', 'lowerLimit': '2.83', 'upperLimit': '3.81'}]}]}, {'title': 'Serotype 6A: Dose 1', 'categories': [{'measurements': [{'value': '2.80', 'groupId': 'OG000', 'lowerLimit': '2.28', 'upperLimit': '3.43'}]}]}, {'title': 'Serotype 6A: Dose 2', 'categories': [{'measurements': [{'value': '3.86', 'groupId': 'OG000', 'lowerLimit': '3.23', 'upperLimit': '4.62'}]}]}, {'title': 'Serotype 6B: Dose 1', 'categories': [{'measurements': [{'value': '2.90', 'groupId': 'OG000', 'lowerLimit': '2.36', 'upperLimit': '3.57'}]}]}, {'title': 'Serotype 6B: Dose 2', 'categories': [{'measurements': [{'value': '4.47', 'groupId': 'OG000', 'lowerLimit': '3.72', 'upperLimit': '5.38'}]}]}, {'title': 'Serotype 7F: Dose 1', 'categories': [{'measurements': [{'value': '3.45', 'groupId': 'OG000', 'lowerLimit': '2.91', 'upperLimit': '4.11'}]}]}, {'title': 'Serotype 7F: Dose 2', 'categories': [{'measurements': [{'value': '3.41', 'groupId': 'OG000', 'lowerLimit': '2.99', 'upperLimit': '3.90'}]}]}, {'title': 'Serotype 9V: Dose 1', 'categories': [{'measurements': [{'value': '2.63', 'groupId': 'OG000', 'lowerLimit': '2.25', 'upperLimit': '3.07'}]}]}, {'title': 'Serotype 9V: Dose 2', 'categories': [{'measurements': [{'value': '2.99', 'groupId': 'OG000', 'lowerLimit': '2.62', 'upperLimit': '3.42'}]}]}, {'title': 'Serotype 14: Dose 1', 'categories': [{'measurements': [{'value': '6.18', 'groupId': 'OG000', 'lowerLimit': '4.97', 'upperLimit': '7.68'}]}]}, {'title': 'Serotype 14: Dose 2', 'categories': [{'measurements': [{'value': '7.60', 'groupId': 'OG000', 'lowerLimit': '6.35', 'upperLimit': '9.09'}]}]}, {'title': 'Serotype 18C: Dose 1', 'categories': [{'measurements': [{'value': '2.87', 'groupId': 'OG000', 'lowerLimit': '2.37', 'upperLimit': '3.48'}]}]}, {'title': 'Serotype 18C: Dose 2', 'categories': [{'measurements': [{'value': '2.68', 'groupId': 'OG000', 'lowerLimit': '2.29', 'upperLimit': '3.13'}]}]}, {'title': 'Serotype 19A: Dose 1', 'categories': [{'measurements': [{'value': '6.53', 'groupId': 'OG000', 'lowerLimit': '5.54', 'upperLimit': '7.69'}]}]}, {'title': 'Serotype 19A: Dose 2', 'categories': [{'measurements': [{'value': '7.63', 'groupId': 'OG000', 'lowerLimit': '6.65', 'upperLimit': '8.74'}]}]}, {'title': 'Serotype 19F: Dose 1', 'categories': [{'measurements': [{'value': '2.75', 'groupId': 'OG000', 'lowerLimit': '2.18', 'upperLimit': '3.49'}]}]}, {'title': 'Serotype 19F: Dose 2', 'categories': [{'measurements': [{'value': '5.70', 'groupId': 'OG000', 'lowerLimit': '4.75', 'upperLimit': '6.84'}]}]}, {'title': 'Serotype 23F: Dose 1', 'categories': [{'measurements': [{'value': '2.62', 'groupId': 'OG000', 'lowerLimit': '2.11', 'upperLimit': '3.25'}]}]}, {'title': 'Serotype 23F: Dose 2', 'categories': [{'measurements': [{'value': '3.82', 'groupId': 'OG000', 'lowerLimit': '3.21', 'upperLimit': '4.56'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month post-dose 1, 1 month post-dose 2', 'description': 'Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for both post-dose 1 and post-dose 2 blood draws.', 'unitOfMeasure': 'mcg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population: eligible participants who were \\>=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.'}, {'type': 'SECONDARY', 'title': 'Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.'}], 'classes': [{'title': 'Serotype 1: Dose 2', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000', 'lowerLimit': '32.6', 'upperLimit': '50.9'}]}]}, {'title': 'Serotype 1: Dose 3', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000', 'lowerLimit': '40.1', 'upperLimit': '61.0'}]}]}, {'title': 'Serotype 3: Dose 2', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000', 'lowerLimit': '36.9', 'upperLimit': '52.4'}]}]}, {'title': 'Serotype 3: Dose 3', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000', 'lowerLimit': '47.5', 'upperLimit': '66.3'}]}]}, {'title': 'Serotype 4: Dose 2', 'categories': [{'measurements': [{'value': '703', 'groupId': 'OG000', 'lowerLimit': '567.6', 'upperLimit': '870.5'}]}]}, {'title': 'Serotype 4: Dose 3', 'categories': [{'measurements': [{'value': '724', 'groupId': 'OG000', 'lowerLimit': '585.2', 'upperLimit': '896.6'}]}]}, {'title': 'Serotype 5: Dose 2', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000', 'lowerLimit': '51.9', 'upperLimit': '86.1'}]}]}, {'title': 'Serotype 5: Dose 3', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000', 'lowerLimit': '57.6', 'upperLimit': '94.2'}]}]}, {'title': 'Serotype 6A: Dose 2', 'categories': [{'measurements': [{'value': '1780', 'groupId': 'OG000', 'lowerLimit': '1392.7', 'upperLimit': '2274.5'}]}]}, {'title': 'Serotype 6A: Dose 3', 'categories': [{'measurements': [{'value': '2139', 'groupId': 'OG000', 'lowerLimit': '1709.0', 'upperLimit': '2678.3'}]}]}, {'title': 'Serotype 6B: Dose 2', 'categories': [{'measurements': [{'value': '1857', 'groupId': 'OG000', 'lowerLimit': '1509.8', 'upperLimit': '2284.3'}]}]}, {'title': 'Serotype 6B: Dose 3', 'categories': [{'measurements': [{'value': '2447', 'groupId': 'OG000', 'lowerLimit': '2011.9', 'upperLimit': '2977.3'}]}]}, {'title': 'Serotype 7F: Dose 2', 'categories': [{'measurements': [{'value': '942', 'groupId': 'OG000', 'lowerLimit': '778.6', 'upperLimit': '1139.6'}]}]}, {'title': 'Serotype 7F: Dose 3', 'categories': [{'measurements': [{'value': '1041', 'groupId': 'OG000', 'lowerLimit': '846.5', 'upperLimit': '1279.4'}]}]}, {'title': 'Serotype 9V: Dose 2', 'categories': [{'measurements': [{'value': '657', 'groupId': 'OG000', 'lowerLimit': '482.7', 'upperLimit': '893.4'}]}]}, {'title': 'Serotype 9V: Dose 3', 'categories': [{'measurements': [{'value': '922', 'groupId': 'OG000', 'lowerLimit': '696.0', 'upperLimit': '1221.7'}]}]}, {'title': 'Serotype 14: Dose 2', 'categories': [{'measurements': [{'value': '746', 'groupId': 'OG000', 'lowerLimit': '614.8', 'upperLimit': '905.8'}]}]}, {'title': 'Serotype 14: Dose 3', 'categories': [{'measurements': [{'value': '819', 'groupId': 'OG000', 'lowerLimit': '684.7', 'upperLimit': '978.8'}]}]}, {'title': 'Serotype 18C: Dose 2', 'categories': [{'measurements': [{'value': '521', 'groupId': 'OG000', 'lowerLimit': '383.9', 'upperLimit': '706.2'}]}]}, {'title': 'Serotype 18C: Dose 3', 'categories': [{'measurements': [{'value': '692', 'groupId': 'OG000', 'lowerLimit': '516.2', 'upperLimit': '927.7'}]}]}, {'title': 'Serotype 19A: Dose 2', 'categories': [{'measurements': [{'value': '401', 'groupId': 'OG000', 'lowerLimit': '340.2', 'upperLimit': '473.0'}]}]}, {'title': 'Serotype 19A: Dose 3', 'categories': [{'measurements': [{'value': '419', 'groupId': 'OG000', 'lowerLimit': '358.2', 'upperLimit': '490.5'}]}]}, {'title': 'Serotype 19F: Dose 2', 'categories': [{'measurements': [{'value': '269', 'groupId': 'OG000', 'lowerLimit': '202.3', 'upperLimit': '357.3'}]}]}, {'title': 'Serotype 19F: Dose 3', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000', 'lowerLimit': '184.2', 'upperLimit': '325.8'}]}]}, {'title': 'Serotype 23F: Dose 2', 'categories': [{'measurements': [{'value': '293', 'groupId': 'OG000', 'lowerLimit': '217.2', 'upperLimit': '395.0'}]}]}, {'title': 'Serotype 23F: Dose 3', 'categories': [{'measurements': [{'value': '393', 'groupId': 'OG000', 'lowerLimit': '295.0', 'upperLimit': '522.7'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month post-dose 2, 1 month post-dose 3', 'description': 'Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for both post-dose 2 and post-dose 3 blood draws.', 'unitOfMeasure': 'titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population: eligible participants who were \\>=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.'}, {'type': 'SECONDARY', 'title': 'Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.'}], 'classes': [{'title': 'Serotype 1: Dose 1', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000', 'lowerLimit': '32.2', 'upperLimit': '50.2'}]}]}, {'title': 'Serotype 1: Dose 2', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000', 'lowerLimit': '32.6', 'upperLimit': '49.7'}]}]}, {'title': 'Serotype 3: Dose 1', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000', 'lowerLimit': '24.0', 'upperLimit': '34.9'}]}]}, {'title': 'Serotype 3: Dose 2', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000', 'lowerLimit': '36.4', 'upperLimit': '51.4'}]}]}, {'title': 'Serotype 4: Dose 1', 'categories': [{'measurements': [{'value': '622', 'groupId': 'OG000', 'lowerLimit': '478.8', 'upperLimit': '806.9'}]}]}, {'title': 'Serotype 4: Dose 2', 'categories': [{'measurements': [{'value': '695', 'groupId': 'OG000', 'lowerLimit': '568.1', 'upperLimit': '850.7'}]}]}, {'title': 'Serotype 5: Dose 1', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000', 'lowerLimit': '51.2', 'upperLimit': '85.7'}]}]}, {'title': 'Serotype 5: Dose 2', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000', 'lowerLimit': '50.8', 'upperLimit': '82.1'}]}]}, {'title': 'Serotype 6A: Dose 1', 'categories': [{'measurements': [{'value': '976', 'groupId': 'OG000', 'lowerLimit': '710.3', 'upperLimit': '1342.0'}]}]}, {'title': 'Serotype 6A: Dose 2', 'categories': [{'measurements': [{'value': '1687', 'groupId': 'OG000', 'lowerLimit': '1317.2', 'upperLimit': '2159.5'}]}]}, {'title': 'Serotype 6B: Dose 1', 'categories': [{'measurements': [{'value': '1088', 'groupId': 'OG000', 'lowerLimit': '806.0', 'upperLimit': '1468.4'}]}]}, {'title': 'Serotype 6B: Dose 2', 'categories': [{'measurements': [{'value': '1789', 'groupId': 'OG000', 'lowerLimit': '1443.4', 'upperLimit': '2216.8'}]}]}, {'title': 'Serotype 7F: Dose 1', 'categories': [{'measurements': [{'value': '786', 'groupId': 'OG000', 'lowerLimit': '606.6', 'upperLimit': '1018.0'}]}]}, {'title': 'Serotype 7F: Dose 2', 'categories': [{'measurements': [{'value': '927', 'groupId': 'OG000', 'lowerLimit': '763.6', 'upperLimit': '1125.2'}]}]}, {'title': 'Serotype 9V: Dose 1', 'categories': [{'measurements': [{'value': '423', 'groupId': 'OG000', 'lowerLimit': '300.6', 'upperLimit': '594.1'}]}]}, {'title': 'Serotype 9V: Dose 2', 'categories': [{'measurements': [{'value': '695', 'groupId': 'OG000', 'lowerLimit': '518.3', 'upperLimit': '932.0'}]}]}, {'title': 'Serotype 14: Dose 1', 'categories': [{'measurements': [{'value': '640', 'groupId': 'OG000', 'lowerLimit': '509.2', 'upperLimit': '805.7'}]}]}, {'title': 'Serotype 14: Dose 2', 'categories': [{'measurements': [{'value': '723', 'groupId': 'OG000', 'lowerLimit': '602.4', 'upperLimit': '867.2'}]}]}, {'title': 'Serotype 18C: Dose 1', 'categories': [{'measurements': [{'value': '475', 'groupId': 'OG000', 'lowerLimit': '338.5', 'upperLimit': '665.5'}]}]}, {'title': 'Serotype 18C: Dose 2', 'categories': [{'measurements': [{'value': '562', 'groupId': 'OG000', 'lowerLimit': '421.7', 'upperLimit': '748.9'}]}]}, {'title': 'Serotype 19A: Dose 1', 'categories': [{'measurements': [{'value': '299', 'groupId': 'OG000', 'lowerLimit': '239.7', 'upperLimit': '372.2'}]}]}, {'title': 'Serotype 19A: Dose 2', 'categories': [{'measurements': [{'value': '391', 'groupId': 'OG000', 'lowerLimit': '333.2', 'upperLimit': '458.6'}]}]}, {'title': 'Serotype 19F: Dose 1', 'categories': [{'measurements': [{'value': '132', 'groupId': 'OG000', 'lowerLimit': '93.6', 'upperLimit': '185.0'}]}]}, {'title': 'Serotype 19F: Dose 2', 'categories': [{'measurements': [{'value': '247', 'groupId': 'OG000', 'lowerLimit': '189.3', 'upperLimit': '322.9'}]}]}, {'title': 'Serotype 23F: Dose 1', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000', 'lowerLimit': '65.6', 'upperLimit': '127.9'}]}]}, {'title': 'Serotype 23F: Dose 2', 'categories': [{'measurements': [{'value': '269', 'groupId': 'OG000', 'lowerLimit': '201.3', 'upperLimit': '360.7'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month post-dose 1, 1 month post-dose 2', 'description': 'Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for both post-dose 2 and post-dose 3 blood draws.', 'unitOfMeasure': 'titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population: eligible participants who were \\>=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.'}, {'type': 'SECONDARY', 'title': 'Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.'}], 'classes': [{'title': 'Serotype 1', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000', 'lowerLimit': '1.06', 'upperLimit': '1.39'}]}]}, {'title': 'Serotype 3', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '1.13', 'upperLimit': '1.44'}]}]}, {'title': 'Serotype 4', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.90', 'upperLimit': '1.18'}]}]}, {'title': 'Serotype 5', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '0.95', 'upperLimit': '1.28'}]}]}, {'title': 'Serotype 6A', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000', 'lowerLimit': '1.04', 'upperLimit': '1.39'}]}]}, {'title': 'Serotype 6B', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '1.16', 'upperLimit': '1.50'}]}]}, {'title': 'Serotype 7F', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '0.95', 'upperLimit': '1.28'}]}]}, {'title': 'Serotype 9V', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000', 'lowerLimit': '1.09', 'upperLimit': '1.81'}]}]}, {'title': 'Serotype 14', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '0.97', 'upperLimit': '1.24'}]}]}, {'title': 'Serotype 18C', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '1.10', 'upperLimit': '1.60'}]}]}, {'title': 'Serotype 19A', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.95', 'upperLimit': '1.15'}]}]}, {'title': 'Serotype 19F', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.76', 'upperLimit': '1.09'}]}]}, {'title': 'Serotype 23F', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '1.16', 'upperLimit': '1.56'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month post-dose 2, 1 month post-dose 3', 'description': 'GMFRs for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month post-dose 2 to 1 month post-dose 3 were computed using the logarithmically transformed assay results. CI for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.', 'unitOfMeasure': 'fold rise', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population: eligible participants who were \\>=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.'}, {'type': 'SECONDARY', 'title': 'Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 1 of 13vPnC to 1 Month After Dose 2 of 13vPnC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.'}], 'classes': [{'title': 'Serotype 1', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.84', 'upperLimit': '1.20'}]}]}, {'title': 'Serotype 3', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '1.29', 'upperLimit': '1.73'}]}]}, {'title': 'Serotype 4', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '0.92', 'upperLimit': '1.36'}]}]}, {'title': 'Serotype 5', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.79', 'upperLimit': '1.20'}]}]}, {'title': 'Serotype 6A', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '1.39', 'upperLimit': '2.15'}]}]}, {'title': 'Serotype 6B', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.34', 'upperLimit': '2.02'}]}]}, {'title': 'Serotype 7F', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000', 'lowerLimit': '0.96', 'upperLimit': '1.45'}]}]}, {'title': 'Serotype 9V', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.26', 'upperLimit': '2.14'}]}]}, {'title': 'Serotype 14', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '0.98', 'upperLimit': '1.30'}]}]}, {'title': 'Serotype 18C', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000', 'lowerLimit': '0.95', 'upperLimit': '1.47'}]}]}, {'title': 'Serotype 19A', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '1.15', 'upperLimit': '1.50'}]}]}, {'title': 'Serotype 19F', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '1.48', 'upperLimit': '2.39'}]}]}, {'title': 'Serotype 23F', 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '2.29', 'upperLimit': '3.77'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month post-dose 1, 1 month post-dose 2', 'description': 'GMFRs for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month post-dose 1 to 1 month post-dose 2 were computed using the logarithmically transformed assay results. CI for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.', 'unitOfMeasure': 'fold rise', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population: eligible participants who were \\>=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.'}], 'classes': [{'title': 'Redness: any (n = 162)', 'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000', 'lowerLimit': '2.6', 'upperLimit': '10.3'}]}]}, {'title': 'Redness: mild (n = 161)', 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '8.8'}]}]}, {'title': 'Redness: moderate (n = 158)', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '4.5'}]}]}, {'title': 'Redness: severe (n = 157)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.3'}]}]}, {'title': 'Swelling: any (n = 162)', 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000', 'lowerLimit': '3.4', 'upperLimit': '11.8'}]}]}, {'title': 'Swelling: mild (n = 161)', 'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '11.1'}]}]}, {'title': 'Swelling: moderate (n = 158)', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.5'}]}]}, {'title': 'Swelling: severe (n = 158)', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.5'}]}]}, {'title': 'Pain: any (n = 260)', 'categories': [{'measurements': [{'value': '78.8', 'groupId': 'OG000', 'lowerLimit': '73.4', 'upperLimit': '83.6'}]}]}, {'title': 'Pain: mild (n = 258)', 'categories': [{'measurements': [{'value': '76.4', 'groupId': 'OG000', 'lowerLimit': '70.7', 'upperLimit': '81.4'}]}]}, {'title': 'Pain: moderate (n = 173)', 'categories': [{'measurements': [{'value': '18.5', 'groupId': 'OG000', 'lowerLimit': '13.0', 'upperLimit': '25.1'}]}]}, {'title': 'Pain: severe (n = 158)', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '4.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 14 days post-dose 1', 'description': 'Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters \\[cm\\]); Moderate (5.5 to 10.0 cm); Severe (greater than \\[\\>\\] 10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population:participants who received at least 1 dose of study vaccine. \'N\'(number of participants analyzed)=participants whose response was "Yes" for any day or "No" for all days. \'n\' = participants whose response was "Yes" for any day or "No" for all days for specified local reaction. Participants may be represented in more than 1 category.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.'}], 'classes': [{'title': 'Redness: any (n = 122)', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '14.6'}]}]}, {'title': 'Redness: mild (n = 120)', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000', 'lowerLimit': '2.9', 'upperLimit': '12.7'}]}]}, {'title': 'Redness: moderate (n = 117)', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '6.0'}]}]}, {'title': 'Redness: severe (n = 117)', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '6.0'}]}]}, {'title': 'Swelling: any (n = 126)', 'categories': [{'measurements': [{'value': '12.7', 'groupId': 'OG000', 'lowerLimit': '7.4', 'upperLimit': '19.8'}]}]}, {'title': 'Swelling: mild (n = 125)', 'categories': [{'measurements': [{'value': '12.0', 'groupId': 'OG000', 'lowerLimit': '6.9', 'upperLimit': '19.0'}]}]}, {'title': 'Swelling: moderate (n = 116)', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '4.7'}]}]}, {'title': 'Swelling: severe (n = 117)', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '6.0'}]}]}, {'title': 'Pain: any (n = 237)', 'categories': [{'measurements': [{'value': '81.4', 'groupId': 'OG000', 'lowerLimit': '75.9', 'upperLimit': '86.2'}]}]}, {'title': 'Pain: mild (n = 230)', 'categories': [{'measurements': [{'value': '78.7', 'groupId': 'OG000', 'lowerLimit': '72.8', 'upperLimit': '83.8'}]}]}, {'title': 'Pain: moderate (n = 150)', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000', 'lowerLimit': '25.9', 'upperLimit': '41.5'}]}]}, {'title': 'Pain: severe (n = 123)', 'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '14.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 14 days post-dose 2', 'description': 'Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 cm); Moderate (5.5 to 10.0 cm); Severe (\\>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population:participants who received at least 1 dose of study vaccine. \'N\'(number of participants analyzed)=participants whose response was "Yes" for any day or "No" for all days. \'n\' = participants whose response was "Yes" for any day or "No" for all days for specified local reaction. Participants may be represented in more than 1 category.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.'}], 'classes': [{'title': 'Redness: any (n = 105)', 'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000', 'lowerLimit': '4.7', 'upperLimit': '16.8'}]}]}, {'title': 'Redness: mild (n = 104)', 'categories': [{'measurements': [{'value': '8.7', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '15.8'}]}]}, {'title': 'Redness: moderate (n = 102)', 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '9.7'}]}]}, {'title': 'Redness: severe (n = 101)', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '5.4'}]}]}, {'title': 'Swelling: any (n = 107)', 'categories': [{'measurements': [{'value': '11.2', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '18.8'}]}]}, {'title': 'Swelling: mild (n = 106)', 'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '15.5'}]}]}, {'title': 'Swelling: moderate (n = 102)', 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '9.7'}]}]}, {'title': 'Swelling: severe (n = 101)', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '5.4'}]}]}, {'title': 'Pain: any (n = 204)', 'categories': [{'measurements': [{'value': '81.9', 'groupId': 'OG000', 'lowerLimit': '75.9', 'upperLimit': '86.9'}]}]}, {'title': 'Pain: mild (n = 197)', 'categories': [{'measurements': [{'value': '80.2', 'groupId': 'OG000', 'lowerLimit': '73.9', 'upperLimit': '85.5'}]}]}, {'title': 'Pain: moderate (n = 129)', 'categories': [{'measurements': [{'value': '30.2', 'groupId': 'OG000', 'lowerLimit': '22.5', 'upperLimit': '38.9'}]}]}, {'title': 'Pain: severe (n = 105)', 'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '12.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 14 days post-dose 3', 'description': 'Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 cm); Moderate (5.5 to 10.0 cm); Severe (\\>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population:participants who received at least 1 dose of study vaccine. \'N\'(number of participants analyzed)=participants whose response was "Yes" for any day or "No" for all days. \'n\' = participants whose response was "Yes" for any day or "No" for all days for specified local reaction. Participants may be represented in more than 1 category.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.'}], 'classes': [{'title': 'Fever >=38 degrees C (n = 162)', 'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '11.1'}]}]}, {'title': 'Fever >=38, <38.5 degrees C (n = 160)', 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '8.0'}]}]}, {'title': 'Fever >=38.5, <39 degrees C (n = 157)', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '4.5'}]}]}, {'title': 'Fever >=39, =<40 degrees C (n = 159)', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '4.5'}]}]}, {'title': 'Fever >40 degrees C (n = 158)', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.5'}]}]}, {'title': 'Fatigue: any (n = 235)', 'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000', 'lowerLimit': '53.4', 'upperLimit': '66.3'}]}]}, {'title': 'Fatigue: mild (n = 223)', 'categories': [{'measurements': [{'value': '54.3', 'groupId': 'OG000', 'lowerLimit': '47.5', 'upperLimit': '60.9'}]}]}, {'title': 'Fatigue: moderate (n = 200)', 'categories': [{'measurements': [{'value': '37.5', 'groupId': 'OG000', 'lowerLimit': '30.8', 'upperLimit': '44.6'}]}]}, {'title': 'Fatigue: severe (n = 163)', 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '11.0'}]}]}, {'title': 'Headache: any (n = 224)', 'categories': [{'measurements': [{'value': '61.6', 'groupId': 'OG000', 'lowerLimit': '54.9', 'upperLimit': '68.0'}]}]}, {'title': 'Headache: mild (n = 216)', 'categories': [{'measurements': [{'value': '57.4', 'groupId': 'OG000', 'lowerLimit': '50.5', 'upperLimit': '64.1'}]}]}, {'title': 'Headache: moderate (n = 183)', 'categories': [{'measurements': [{'value': '31.1', 'groupId': 'OG000', 'lowerLimit': '24.5', 'upperLimit': '38.4'}]}]}, {'title': 'Headache: severe (n = 160)', 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '7.1'}]}]}, {'title': 'Vomiting: any (n = 164)', 'categories': [{'measurements': [{'value': '11.6', 'groupId': 'OG000', 'lowerLimit': '7.1', 'upperLimit': '17.5'}]}]}, {'title': 'Vomiting: mild (n = 164)', 'categories': [{'measurements': [{'value': '11.6', 'groupId': 'OG000', 'lowerLimit': '7.1', 'upperLimit': '17.5'}]}]}, {'title': 'Vomiting: moderate (n = 157)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.3'}]}]}, {'title': 'Vomiting: severe (n = 157)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.3'}]}]}, {'title': 'Diarrhea: any (n = 193)', 'categories': [{'measurements': [{'value': '44.0', 'groupId': 'OG000', 'lowerLimit': '36.9', 'upperLimit': '51.3'}]}]}, {'title': 'Diarrhea: mild (n = 191)', 'categories': [{'measurements': [{'value': '40.3', 'groupId': 'OG000', 'lowerLimit': '33.3', 'upperLimit': '47.6'}]}]}, {'title': 'Diarrhea: moderate (n = 166)', 'categories': [{'measurements': [{'value': '12.7', 'groupId': 'OG000', 'lowerLimit': '8.0', 'upperLimit': '18.7'}]}]}, {'title': 'Diarrhea: severe (n = 160)', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '5.4'}]}]}, {'title': 'New generalized muscle pain: any (n = 234)', 'categories': [{'measurements': [{'value': '65.0', 'groupId': 'OG000', 'lowerLimit': '58.5', 'upperLimit': '71.1'}]}]}, {'title': 'New generalized muscle pain: mild (n = 230)', 'categories': [{'measurements': [{'value': '60.4', 'groupId': 'OG000', 'lowerLimit': '53.8', 'upperLimit': '66.8'}]}]}, {'title': 'New generalized muscle pain: moderate (n = 183)', 'categories': [{'measurements': [{'value': '29.5', 'groupId': 'OG000', 'lowerLimit': '23.0', 'upperLimit': '36.7'}]}]}, {'title': 'New generalized muscle pain: severe (n = 161)', 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '7.9'}]}]}, {'title': 'New generalized joint pain: any (n = 193)', 'categories': [{'measurements': [{'value': '35.8', 'groupId': 'OG000', 'lowerLimit': '29.0', 'upperLimit': '43.0'}]}]}, {'title': 'New generalized joint pain: mild (n = 185)', 'categories': [{'measurements': [{'value': '29.7', 'groupId': 'OG000', 'lowerLimit': '23.2', 'upperLimit': '36.9'}]}]}, {'title': 'New generalized joint pain: moderate (n = 172)', 'categories': [{'measurements': [{'value': '19.2', 'groupId': 'OG000', 'lowerLimit': '13.6', 'upperLimit': '25.9'}]}]}, {'title': 'New generalized joint pain: severe (n = 159)', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '4.5'}]}]}, {'title': 'Use of medication to treat pain (n = 185)', 'categories': [{'measurements': [{'value': '29.7', 'groupId': 'OG000', 'lowerLimit': '23.2', 'upperLimit': '36.9'}]}]}, {'title': 'Use of medication to treat fever (n = 173)', 'categories': [{'measurements': [{'value': '17.3', 'groupId': 'OG000', 'lowerLimit': '12.0', 'upperLimit': '23.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 14 days post-dose 1', 'description': 'Specific systemic events (fever greater than or equal to \\[\\>=\\]38 degrees Celsius\\[C\\], fatigue, headache, vomiting, diarrhea, new generalized muscle/joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, new generalized muscle and joint pain were scaled as: Any (symptom present); Mild (no interference with activity); Moderate (some interference); Severe (prevents routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours \\[hrs\\]); Moderate (\\>2 times in 24 hrs); Severe (requires intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hrs); Moderate (4-5 loose stools 24 hrs); Severe (\\>=6 loose stools in 24 hrs). Report of fever \\>40 degrees C after 13vPnC Dose 1 was confirmed as data entry error.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population:participants who received at least 1 dose of study vaccine. \'N\'(number of participants analyzed)=participants whose response was "Yes" for any day or "No" for all days. \'n\' = participants whose response was "Yes" for any day or "No" for all days for specified systemic event. Participants may be represented in more than 1 category.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.'}], 'classes': [{'title': 'Fever >=38 degrees C (n = 117)', 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '10.8'}]}]}, {'title': 'Fever >=38, <38.5 degrees C (n = 116)', 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '9.8'}]}]}, {'title': 'Fever >=38.5, <39 degrees C (n = 116)', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '4.7'}]}]}, {'title': 'Fever >=39, =<40 degrees C (n = 115)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.2'}]}]}, {'title': 'Fever >40 degrees C (n = 115)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.2'}]}]}, {'title': 'Fatigue: any (n = 188)', 'categories': [{'measurements': [{'value': '63.3', 'groupId': 'OG000', 'lowerLimit': '56.0', 'upperLimit': '70.2'}]}]}, {'title': 'Fatigue: mild (n = 176)', 'categories': [{'measurements': [{'value': '57.4', 'groupId': 'OG000', 'lowerLimit': '49.7', 'upperLimit': '64.8'}]}]}, {'title': 'Fatigue: moderate (n = 154)', 'categories': [{'measurements': [{'value': '38.3', 'groupId': 'OG000', 'lowerLimit': '30.6', 'upperLimit': '46.5'}]}]}, {'title': 'Fatigue: severe (n = 121)', 'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000', 'lowerLimit': '3.5', 'upperLimit': '13.7'}]}]}, {'title': 'Headache: any (n = 173)', 'categories': [{'measurements': [{'value': '56.1', 'groupId': 'OG000', 'lowerLimit': '48.3', 'upperLimit': '63.6'}]}]}, {'title': 'Headache: mild (n = 165)', 'categories': [{'measurements': [{'value': '48.5', 'groupId': 'OG000', 'lowerLimit': '40.6', 'upperLimit': '56.4'}]}]}, {'title': 'Headache: moderate (n = 142)', 'categories': [{'measurements': [{'value': '31.0', 'groupId': 'OG000', 'lowerLimit': '23.5', 'upperLimit': '39.3'}]}]}, {'title': 'Headache: severe (n = 117)', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '8.5'}]}]}, {'title': 'Vomiting: any (n = 120)', 'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000', 'lowerLimit': '3.5', 'upperLimit': '13.8'}]}]}, {'title': 'Vomiting: mild (n = 119)', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000', 'lowerLimit': '2.9', 'upperLimit': '12.8'}]}]}, {'title': 'Vomiting: moderate (n = 116)', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '4.7'}]}]}, {'title': 'Vomiting: severe (n = 115)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.2'}]}]}, {'title': 'Diarrhea: any (n = 155)', 'categories': [{'measurements': [{'value': '44.5', 'groupId': 'OG000', 'lowerLimit': '36.5', 'upperLimit': '52.7'}]}]}, {'title': 'Diarrhea: mild (n = 147)', 'categories': [{'measurements': [{'value': '39.5', 'groupId': 'OG000', 'lowerLimit': '31.5', 'upperLimit': '47.8'}]}]}, {'title': 'Diarrhea: moderate (n = 130)', 'categories': [{'measurements': [{'value': '15.4', 'groupId': 'OG000', 'lowerLimit': '9.7', 'upperLimit': '22.8'}]}]}, {'title': 'Diarrhea: severe (n = 119)', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '10.7'}]}]}, {'title': 'New generalized muscle pain: any (n = 199)', 'categories': [{'measurements': [{'value': '71.9', 'groupId': 'OG000', 'lowerLimit': '65.1', 'upperLimit': '78.0'}]}]}, {'title': 'New generalized muscle pain: mild (n = 188)', 'categories': [{'measurements': [{'value': '66.0', 'groupId': 'OG000', 'lowerLimit': '58.7', 'upperLimit': '72.7'}]}]}, {'title': 'New generalized muscle pain: moderate (n = 153)', 'categories': [{'measurements': [{'value': '38.6', 'groupId': 'OG000', 'lowerLimit': '30.8', 'upperLimit': '46.8'}]}]}, {'title': 'New generalized muscle pain: severe (n = 125)', 'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG000', 'lowerLimit': '5.7', 'upperLimit': '17.1'}]}]}, {'title': 'New generalized joint pain: any (n = 150)', 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000', 'lowerLimit': '32.1', 'upperLimit': '48.3'}]}]}, {'title': 'New generalized joint pain: mild (n = 144)', 'categories': [{'measurements': [{'value': '34.7', 'groupId': 'OG000', 'lowerLimit': '27.0', 'upperLimit': '43.1'}]}]}, {'title': 'New generalized joint pain: moderate (n = 135)', 'categories': [{'measurements': [{'value': '21.5', 'groupId': 'OG000', 'lowerLimit': '14.9', 'upperLimit': '29.4'}]}]}, {'title': 'New generalized joint pain: severe (n = 119)', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '8.4'}]}]}, {'title': 'Use of medication to treat pain (n = 141)', 'categories': [{'measurements': [{'value': '35.5', 'groupId': 'OG000', 'lowerLimit': '27.6', 'upperLimit': '44.0'}]}]}, {'title': 'Use of medication to treat fever (n = 127)', 'categories': [{'measurements': [{'value': '18.9', 'groupId': 'OG000', 'lowerLimit': '12.5', 'upperLimit': '26.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 14 days post-dose 2', 'description': 'Specific systemic events (fever \\>=38 degrees C, fatigue, headache, vomiting, diarrhea, new generalized muscle/joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, new generalized muscle and joint pain were scaled as: Any (symptom present); Mild (no interference with activity); Moderate (some interference); Severe (prevents routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hrs); Moderate (\\>2 times in 24 hrs); Severe (requires intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hrs); Moderate (4-5 loose stools 24 hrs); Severe (\\>=6 loose stools in 24 hrs).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population:participants who received at least 1 dose of study vaccine. \'N\'(number of participants analyzed)=participants whose response was "Yes" for any day or "No" for all days. \'n\' = participants whose response was "Yes" for any day or "No" for all days for specified systemic event. Participants may be represented in more than 1 category.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': 'Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.'}], 'classes': [{'title': 'Fever >=38 degrees C (n = 104)', 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000', 'lowerLimit': '3.4', 'upperLimit': '14.6'}]}]}, {'title': 'Fever >=38, <38.5 degrees C (n = 104)', 'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '10.9'}]}]}, {'title': 'Fever >=38.5, <39 degrees C (n = 101)', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '5.4'}]}]}, {'title': 'Fever >=39, =<40 degrees C (n = 101)', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '7.0'}]}]}, {'title': 'Fever >40 degrees C (n = 101)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.6'}]}]}, {'title': 'Fatigue: any (n = 160)', 'categories': [{'measurements': [{'value': '56.3', 'groupId': 'OG000', 'lowerLimit': '48.2', 'upperLimit': '64.1'}]}]}, {'title': 'Fatigue: mild (n = 149)', 'categories': [{'measurements': [{'value': '48.3', 'groupId': 'OG000', 'lowerLimit': '40.1', 'upperLimit': '56.6'}]}]}, {'title': 'Fatigue: moderate (n = 132)', 'categories': [{'measurements': [{'value': '36.4', 'groupId': 'OG000', 'lowerLimit': '28.2', 'upperLimit': '45.2'}]}]}, {'title': 'Fatigue: severe (n = 105)', 'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '12.0'}]}]}, {'title': 'Headache: any (n = 137)', 'categories': [{'measurements': [{'value': '46.7', 'groupId': 'OG000', 'lowerLimit': '38.1', 'upperLimit': '55.4'}]}]}, {'title': 'Headache: mild (n = 130)', 'categories': [{'measurements': [{'value': '40.8', 'groupId': 'OG000', 'lowerLimit': '32.2', 'upperLimit': '49.7'}]}]}, {'title': 'Headache: moderate (n = 118)', 'categories': [{'measurements': [{'value': '24.6', 'groupId': 'OG000', 'lowerLimit': '17.1', 'upperLimit': '33.4'}]}]}, {'title': 'Headache: severe (n = 103)', 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '11.0'}]}]}, {'title': 'Vomiting: any (n = 109)', 'categories': [{'measurements': [{'value': '11.0', 'groupId': 'OG000', 'lowerLimit': '5.8', 'upperLimit': '18.4'}]}]}, {'title': 'Vomiting: mild (n = 107)', 'categories': [{'measurements': [{'value': '8.4', 'groupId': 'OG000', 'lowerLimit': '3.9', 'upperLimit': '15.4'}]}]}, {'title': 'Vomiting: moderate (n = 104)', 'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '10.9'}]}]}, {'title': 'Vomiting: severe (n = 101)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.6'}]}]}, {'title': 'Diarrhea: any (n = 134)', 'categories': [{'measurements': [{'value': '38.8', 'groupId': 'OG000', 'lowerLimit': '30.5', 'upperLimit': '47.6'}]}]}, {'title': 'Diarrhea: mild (n = 131)', 'categories': [{'measurements': [{'value': '35.9', 'groupId': 'OG000', 'lowerLimit': '27.7', 'upperLimit': '44.7'}]}]}, {'title': 'Diarrhea: moderate (n = 109)', 'categories': [{'measurements': [{'value': '11.9', 'groupId': 'OG000', 'lowerLimit': '6.5', 'upperLimit': '19.5'}]}]}, {'title': 'Diarrhea: severe (n = 103)', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '6.8'}]}]}, {'title': 'New generalized muscle pain: any (n = 170)', 'categories': [{'measurements': [{'value': '65.9', 'groupId': 'OG000', 'lowerLimit': '58.2', 'upperLimit': '73.0'}]}]}, {'title': 'New generalized muscle pain: mild (n = 155)', 'categories': [{'measurements': [{'value': '61.3', 'groupId': 'OG000', 'lowerLimit': '53.1', 'upperLimit': '69.0'}]}]}, {'title': 'New generalized muscle pain: moderate (n = 132)', 'categories': [{'measurements': [{'value': '31.1', 'groupId': 'OG000', 'lowerLimit': '23.3', 'upperLimit': '39.7'}]}]}, {'title': 'New generalized muscle pain: severe (n = 110)', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000', 'lowerLimit': '5.1', 'upperLimit': '17.2'}]}]}, {'title': 'New generalized joint pain: any (n = 129)', 'categories': [{'measurements': [{'value': '31.8', 'groupId': 'OG000', 'lowerLimit': '23.9', 'upperLimit': '40.6'}]}]}, {'title': 'New generalized joint pain: mild (n = 119)', 'categories': [{'measurements': [{'value': '26.1', 'groupId': 'OG000', 'lowerLimit': '18.4', 'upperLimit': '34.9'}]}]}, {'title': 'New generalized joint pain: moderate (n = 120)', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000', 'lowerLimit': '13.3', 'upperLimit': '28.3'}]}]}, {'title': 'New generalized joint pain: severe (n = 106)', 'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '11.9'}]}]}, {'title': 'Use of medication to treat pain (n = 122)', 'categories': [{'measurements': [{'value': '32.0', 'groupId': 'OG000', 'lowerLimit': '23.8', 'upperLimit': '41.0'}]}]}, {'title': 'Use of medication to treat fever (n = 118)', 'categories': [{'measurements': [{'value': '25.4', 'groupId': 'OG000', 'lowerLimit': '17.9', 'upperLimit': '34.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 14 days post-dose 3', 'description': 'Specific systemic events (fever \\>=38 degrees C, fatigue, headache, vomiting, diarrhea, new generalized muscle/joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, new generalized muscle and joint pain were scaled as: Any (symptom present); Mild (no interference with activity); Moderate (some interference); Severe (prevents routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hrs); Moderate (\\>2 times in 24 hrs); Severe (requires intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hrs); Moderate (4-5 loose stools 24 hrs); Severe (\\>=6 loose stools in 24 hrs).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population:participants who received at least 1 dose of study vaccine. \'N\'(number of participants analyzed)=participants whose response was "Yes" for any day or "No" for all days. \'n\' = participants whose response was "Yes" for any day or "No" for all days for specified systemic event. Participants may be represented in more than 1 category.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '13vPnC', 'description': 'Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '331'}]}, {'type': 'Vaccinated Dose 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '329'}]}, {'type': 'Vaccinated Dose 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '300'}]}, {'type': 'Vaccinated Dose 3', 'achievements': [{'groupId': 'FG000', 'numSubjects': '279'}]}, {'type': 'Completed Dose 3 1-month Blood Draw', 'achievements': [{'groupId': 'FG000', 'numSubjects': '277'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '271'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'Failed to return', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': '13vPnC', 'description': 'Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.3', 'spread': '9.10', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '66', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '263', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population included participants who received at least 1 dose of study vaccine.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 331}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-17', 'studyFirstSubmitDate': '2009-08-20', 'resultsFirstSubmitDate': '2013-04-17', 'studyFirstSubmitQcDate': '2009-08-20', 'lastUpdatePostDateStruct': {'date': '2013-06-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-04-17', 'studyFirstPostDateStruct': {'date': '2009-08-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1', 'timeFrame': 'Within 14 days post-dose 1', 'description': 'Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters \\[cm\\]); Moderate (5.5 to 10.0 cm); Severe (greater than \\[\\>\\] 10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating).'}, {'measure': 'Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2', 'timeFrame': 'Within 14 days post-dose 2', 'description': 'Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 cm); Moderate (5.5 to 10.0 cm); Severe (\\>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating).'}, {'measure': 'Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3', 'timeFrame': 'Within 14 days post-dose 3', 'description': 'Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 cm); Moderate (5.5 to 10.0 cm); Severe (\\>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating).'}, {'measure': 'Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1', 'timeFrame': 'Within 14 days post-dose 1', 'description': 'Specific systemic events (fever greater than or equal to \\[\\>=\\]38 degrees Celsius\\[C\\], fatigue, headache, vomiting, diarrhea, new generalized muscle/joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, new generalized muscle and joint pain were scaled as: Any (symptom present); Mild (no interference with activity); Moderate (some interference); Severe (prevents routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours \\[hrs\\]); Moderate (\\>2 times in 24 hrs); Severe (requires intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hrs); Moderate (4-5 loose stools 24 hrs); Severe (\\>=6 loose stools in 24 hrs). Report of fever \\>40 degrees C after 13vPnC Dose 1 was confirmed as data entry error.'}, {'measure': 'Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2', 'timeFrame': 'Within 14 days post-dose 2', 'description': 'Specific systemic events (fever \\>=38 degrees C, fatigue, headache, vomiting, diarrhea, new generalized muscle/joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, new generalized muscle and joint pain were scaled as: Any (symptom present); Mild (no interference with activity); Moderate (some interference); Severe (prevents routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hrs); Moderate (\\>2 times in 24 hrs); Severe (requires intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hrs); Moderate (4-5 loose stools 24 hrs); Severe (\\>=6 loose stools in 24 hrs).'}, {'measure': 'Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3', 'timeFrame': 'Within 14 days post-dose 3', 'description': 'Specific systemic events (fever \\>=38 degrees C, fatigue, headache, vomiting, diarrhea, new generalized muscle/joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, new generalized muscle and joint pain were scaled as: Any (symptom present); Mild (no interference with activity); Moderate (some interference); Severe (prevents routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hrs); Moderate (\\>2 times in 24 hrs); Severe (requires intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hrs); Moderate (4-5 loose stools 24 hrs); Severe (\\>=6 loose stools in 24 hrs).'}], 'primaryOutcomes': [{'measure': 'Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC', 'timeFrame': '1 month post-dose 2, 1 month post-dose 3', 'description': 'Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month post-dose 2 to 1 month post-dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.'}], 'secondaryOutcomes': [{'measure': 'Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC', 'timeFrame': '1 month post-dose 2, 1 month post-dose 3', 'description': 'Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means (GMs) were calculated using all participants with available data for both post-dose 2 and post-dose 3 blood draws.'}, {'measure': 'Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC', 'timeFrame': '1 month post-dose 1, 1 month post-dose 2', 'description': 'Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for both post-dose 1 and post-dose 2 blood draws.'}, {'measure': 'Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC', 'timeFrame': '1 month post-dose 2, 1 month post-dose 3', 'description': 'Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for both post-dose 2 and post-dose 3 blood draws.'}, {'measure': 'Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC', 'timeFrame': '1 month post-dose 1, 1 month post-dose 2', 'description': 'Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for both post-dose 2 and post-dose 3 blood draws.'}, {'measure': 'Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC', 'timeFrame': '1 month post-dose 2, 1 month post-dose 3', 'description': 'GMFRs for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month post-dose 2 to 1 month post-dose 3 were computed using the logarithmically transformed assay results. CI for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.'}, {'measure': 'Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 1 of 13vPnC to 1 Month After Dose 2 of 13vPnC', 'timeFrame': '1 month post-dose 1, 1 month post-dose 2', 'description': 'GMFRs for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month post-dose 1 to 1 month post-dose 2 were computed using the logarithmically transformed assay results. CI for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['vaccine', '13-valent pneumococcal conjugate vaccine', 'human immunodeficiency virus'], 'conditions': ['HIV Infections', 'Pneumococcal Infections']}, 'referencesModule': {'references': [{'pmid': '25395187', 'type': 'DERIVED', 'citation': 'Glesby MJ, Watson W, Brinson C, Greenberg RN, Lalezari JP, Skiest D, Sundaraiyer V, Natuk R, Gurtman A, Scott DA, Emini EA, Gruber WC, Schmoele-Thoma B. Immunogenicity and Safety of 13-Valent Pneumococcal Conjugate Vaccine in HIV-Infected Adults Previously Vaccinated With Pneumococcal Polysaccharide Vaccine. J Infect Dis. 2015 Jul 1;212(1):18-27. doi: 10.1093/infdis/jiu631. Epub 2014 Nov 13.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=6115A1-3017&StudyName=Safety%20%26%20Immunogenicity%20of%2013vPnC%20in%20HIV-Infected%20Subjects%20Aged%2018%20or%20Older%20Who%20Were%20Previously%20Immunized%20with%2023vPS', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The study will evaluate the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC) in HIV-infected subjects 18 years of age or older who have been previously immunized with at least one dose of 23-valent pneumococcal polysaccharide vaccine (23vPS). All subjects will receive 3 doses of 13vPnC, with each study vaccine dose given approximately 6 months apart.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female subjects aged 18 years or older at the time of enrollment.\n* All female and male subjects who are biologically capable of having children must agree and commit to the use of a reliable method of birth control from the signing of the informed consent form (ICF) until 3 months after the last dose of investigational product.\n* Documented vaccination with 1 or more doses of 23vPS at least 6 months before study enrollment.\n* CD4+ T-cell count \\>= 200 cells/µ, obtained on the most recent 2 occasions within 6 months before the first investigational product vaccination.\n* HIV-infected subjects with viral load \\<50,000 copies/mL, obtained on the most recent 2 occasions within 6 months before the first investigational product vaccination.\n* Subject is receiving a stable dose of HAART for at least 6 weeks prior to the first investigational product vaccination, or not currently receiving antiretroviral therapy.\n* Subject is expected to be available for the entire study period (approximately 18 months) and can be contacted by telephone.\n* Subject must be able to complete an electronic diary (e-diary) and complete all relevant study procedures during study participation.\n* Subject is deemed to be eligible for the study on the basis of medical history, physical examination, and clinical judgment. (Note: Subjects with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease 6 weeks before investigational product vaccination, are eligible.)\n\nExclusion Criteria:\n\n* Subjects with active AIDS related illness, including opportunistic infections or malignancy.\n* Evidence of current illicit substance and/or alcohol abuse, that in the investigator's opinion, precludes the subject from participating in the study or interferes with the evaluation of the study objectives..\n* Receipt of any licensed or experimental pneumococcal conjugate vaccine prior to enrollment.\n* Contraindication to vaccination with pneumococcal conjugate vaccine.\n* Previous anaphylactic reaction to any vaccine or vaccine-related component.\n* History of culture-proven invasive disease caused by Streptococcus pneumoniae within the last year.\n* Current anticoagulant therapy or a history of bleeding diathesis or any condition associated with prolonged bleeding time that would contraindicate intramuscular injection. (Note: Use of antiplatelet drugs, such as aspirin and clopidogrel, is permitted.)\n* Pregnant or breastfeeding women, as defined by history or positive human chorionic gonadotropin (hCG) urine test. All women of childbearing potential must have a urine pregnancy test.\n* History of active hepatitis with elevation in pretreatment aspartate aminotransferase (AST) or alanine aminotransferase (ALT) values \\>5 times the upper limit of normal within the last 6 months.\n* Serious chronic disorder or any other disorder that, in the investigator's opinion, precludes the subject from participating in the study or interferes with the evaluation of the study objectives. (Note: Serious chronic disorders include metastatic malignancy, severe chronic obstructive pulmonary disease requiring supplemental oxygen, end-stage renal disease with or without dialysis, and clinically unstable cardiac disease).\n* Any major illness/condition that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of, the study, or could preclude the evaluation of the subject's response.\n* History of splenectomy.\n* Receipt of any blood products, including immunoglobulin, within 42 days before investigational product vaccination until the last blood draw for the study (approximately 13 months after the first investigational product vaccination).\n* Evidence of dementia or other severe cognitive impairment.\n* Subject who is, in the opinion of the investigator, unable to receive a vaccination in the deltoid muscle of either arm because of insufficient muscle mass.\n* Participation in another study using investigational product from 28 days before study enrollment until the blood draw at visit 6. Between the blood draw at visit 6 and the 6 month follow-up telephone call (visit 7), use of investigational product must be discussed with the Medical Monitor. (Note: Participation in purely observational studies is acceptable.)\n* Residence in a nursing home, long-term care facility, or other institution or requirement of semi-skilled nursing care. An ambulatory resident of a retirement home or village is eligible for the trial.\n* Subject who is a direct relative (child, grandchild, parent, or grandparent) of study personnel, or who is study personnel.\n\nTemporary Delay Criteria:\n\n* Current febrile illness (oral temperature of =38.0°C \\[100.4°F\\]) or other acute illness within 48 hours before study vaccine administration.\n* Currently receiving antibiotic therapy, or has completed a course of antibiotic therapy within 10 days before study vaccine administration.\n* Receipt of novel influenza A (H1N1) vaccine within 14 days before investigational product vaccination (seasonal influenza vaccine can be given at any time at the discretion of the investigator)."}, 'identificationModule': {'nctId': 'NCT00963235', 'briefTitle': 'Safety & Immunogenicity of 13vPnC in HIV-Infected Subjects Aged 18 or Older Who Were Previously Immunized With 23vPS', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 3, Open-label, Single-Arm Trial to Evaluate the Safety, Tolerability, and Immunogenicity of 3 Doses of 13vPnC Vaccine in HIV-Infected Subjects 18 Years of Age or Older Who Have Been Previously Immunized With 23vPS Vaccine', 'orgStudyIdInfo': {'id': '6115A1-3017'}, 'secondaryIdInfos': [{'id': 'B1851028'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Biological: 13-valent pneumococcal conjugate vaccine', 'Procedure: Blood draw']}], 'interventions': [{'name': '13-valent pneumococcal conjugate vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['13vPnC'], 'description': 'Three doses of 13vPnC given 6 months apart.', 'armGroupLabels': ['1']}, {'name': 'Blood draw', 'type': 'PROCEDURE', 'description': 'Six blood draws pre-vaccination and 1 month post-vaccination, doses 1-3.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '20009', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '01199', 'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10011', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '37604', 'city': 'Johnson City', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 36.31344, 'lon': -82.35347}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}