Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2026-01-02 @ 2:09 AM
Study NCT ID:
NCT00485732
Status:
COMPLETED
Last Update Posted:
2018-07-20
First Post:
2007-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Immune Response and Safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine/Cervarix TM Vaccine in Healthy Females Aged 15-25 Years
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D030361', 'term': 'Papillomavirus Infections'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C510352', 'term': 'human papillomavirus vaccine, L1 type 16, 18'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.', 'otherNumAtRisk': 149, 'otherNumAffected': 144, 'seriousNumAtRisk': 149, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Placebo Group', 'description': 'Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.', 'otherNumAtRisk': 76, 'otherNumAffected': 70, 'seriousNumAtRisk': 76, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Upper respiratoy tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysmenorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 3}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 140}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 64}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Redness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 109}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 35}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 89}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 30}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 97}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 33}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 103}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 39}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ovarian cyst ruptured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pelvic inflammatory disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.'}], 'classes': [{'title': 'Anti-HPV-16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '125', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Anti-HPV-18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '122', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'One month post Dose 3 (Month 7)', 'description': 'Seroconversion is defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination.\n\nCut-off values were 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on initially seronegative subjects from the According-to-Protocol (ATP) cohort for immunogenicity.'}, {'type': 'SECONDARY', 'title': 'Anti-HPV-16 and Anti-HPV-18 Antibody Titres', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.'}], 'classes': [{'title': 'Anti-HPV-16 (PRE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000', 'lowerLimit': '4.2', 'upperLimit': '5.1'}, {'value': '4.8', 'groupId': 'OG001', 'lowerLimit': '4.1', 'upperLimit': '5.7'}]}]}, {'title': 'Anti-HPV-16 (Month 7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9226.4', 'groupId': 'OG000', 'lowerLimit': '8085.4', 'upperLimit': '10528.4'}, {'value': '4.9', 'groupId': 'OG001', 'lowerLimit': '4.2', 'upperLimit': '5.8'}]}]}, {'title': 'Anti-HPV-18 (PRE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '3.7', 'upperLimit': '4.4'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '3.5', 'upperLimit': '4.5'}]}]}, {'title': 'Anti-HPV-18 (Month 7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4240.2', 'groupId': 'OG000', 'lowerLimit': '3692.1', 'upperLimit': '4869.7'}, {'value': '4.3', 'groupId': 'OG001', 'lowerLimit': '3.7', 'upperLimit': '5.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Before vaccination (PRE) and one month post Dose 3 (Month 7)', 'description': 'Titres are given as geometric mean titres (GMTs) calculated on all subjects.', 'unitOfMeasure': 'titre', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the ATP cohort for immunogenicity.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Solicited Local Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.'}], 'classes': [{'title': 'Pain', 'categories': [{'measurements': [{'value': '140', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}, {'title': 'Redness', 'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Swelling', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 7-day (Days 0-6) period following each vaccination', 'description': 'Solicited local symptoms assessed include pain, redness and swelling at the injection site.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Total vaccinated cohort on the subjects with available data.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Solicited General Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.'}], 'classes': [{'title': 'Arthralgia', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'Fever', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Gastrointestinal symptoms', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'Rash', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Urticaria', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 7-day (Days 0-6) period following each vaccination', 'description': 'Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash, and urticaria.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Total vaccinated cohort on the subjects with available data.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Unsolicited Adverse Events (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 30-day (Days 0-29) period following each vaccination', 'description': 'Unsolicited adverse event= Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.'}], 'classes': [{'title': 'NOCD', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Medically Significant Conditions', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 up to Month 7', 'description': 'NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. Medically significant AEs assessed include AEs prompting emergency room visits and physician office visits not related to common illnesses or Serious Adverse Events (SAEs) that are not related to common illnesses.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Serious Adverse Events (SAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 0 up to Month 7', 'description': 'Serious adverse events assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Pregnancies and Their Outcome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.'}], 'classes': [{'title': 'Total', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Elective abortion', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from Day 0 up to Month 7', 'description': 'Total: the total number of pregnancies in a group. The specific outcomes are also listed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on subjects with a pregnancy.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.'}, {'id': 'FG001', 'title': 'Placebo Group', 'description': 'Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '149'}, {'groupId': 'FG001', 'numSubjects': '76'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '141'}, {'groupId': 'FG001', 'numSubjects': '67'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '225', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.'}, {'id': 'BG001', 'title': 'Placebo Group', 'description': 'Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '22.0', 'spread': '2.24', 'groupId': 'BG000'}, {'value': '21.9', 'spread': '2.63', 'groupId': 'BG001'}, {'value': '22.0', 'spread': '2.37', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '149', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '225', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 225}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2008-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-24', 'studyFirstSubmitDate': '2007-06-12', 'resultsFirstSubmitDate': '2009-11-12', 'studyFirstSubmitQcDate': '2007-06-12', 'lastUpdatePostDateStruct': {'date': '2018-07-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-11-12', 'studyFirstPostDateStruct': {'date': '2007-06-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies', 'timeFrame': 'One month post Dose 3 (Month 7)', 'description': 'Seroconversion is defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination.\n\nCut-off values were 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.'}], 'secondaryOutcomes': [{'measure': 'Anti-HPV-16 and Anti-HPV-18 Antibody Titres', 'timeFrame': 'Before vaccination (PRE) and one month post Dose 3 (Month 7)', 'description': 'Titres are given as geometric mean titres (GMTs) calculated on all subjects.'}, {'measure': 'Number of Subjects Reporting Solicited Local Symptoms', 'timeFrame': 'During the 7-day (Days 0-6) period following each vaccination', 'description': 'Solicited local symptoms assessed include pain, redness and swelling at the injection site.'}, {'measure': 'Number of Subjects Reporting Solicited General Symptoms', 'timeFrame': 'During the 7-day (Days 0-6) period following each vaccination', 'description': 'Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash, and urticaria.'}, {'measure': 'Number of Subjects Reporting Unsolicited Adverse Events (AE)', 'timeFrame': 'During the 30-day (Days 0-29) period following each vaccination', 'description': 'Unsolicited adverse event= Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.'}, {'measure': 'Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions', 'timeFrame': 'From Day 0 up to Month 7', 'description': 'NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. Medically significant AEs assessed include AEs prompting emergency room visits and physician office visits not related to common illnesses or Serious Adverse Events (SAEs) that are not related to common illnesses.'}, {'measure': 'Number of Subjects Reporting Serious Adverse Events (SAE)', 'timeFrame': 'From Day 0 up to Month 7', 'description': 'Serious adverse events assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.'}, {'measure': 'Number of Subjects With Pregnancies and Their Outcome', 'timeFrame': 'from Day 0 up to Month 7', 'description': 'Total: the total number of pregnancies in a group. The specific outcomes are also listed.'}]}, 'conditionsModule': {'keywords': ['Cervical neoplasia', 'AS04', 'Randomized', 'Cervical cancer', 'HPV-16/18 L1 VLP AS04', 'Phase IIIb', 'Korea', 'HPV', 'Double-blind', 'Controlled'], 'conditions': ['Infections, Papillomavirus']}, 'referencesModule': {'availIpds': [{'id': '107291', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '107291', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Individual Participant Data Set', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '107291', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '107291', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '107291', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '107291', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Annotated Case Report Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '107291', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'references': [{'pmid': '21860731', 'type': 'BACKGROUND', 'citation': 'Kim SC, Song YS, Kim YT, Kim YT, Ryu KS, Gunapalaiah B, Bi D, Bock HL, Park JS. Human papillomavirus 16/18 AS04-adjuvanted cervical cancer vaccine: immunogenicity and safety in 15-25 years old healthy Korean women. J Gynecol Oncol. 2011 Jun 30;22(2):67-75. doi: 10.3802/jgo.2011.22.2.67.'}, {'pmid': '18845199', 'type': 'BACKGROUND', 'citation': 'Verstraeten T, Descamps D, David MP, Zahaf T, Hardt K, Izurieta P, Dubin G, Breuer T. Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 2008 Dec 2;26(51):6630-8. doi: 10.1016/j.vaccine.2008.09.049.'}, {'pmid': '41276263', 'type': 'DERIVED', 'citation': 'Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.'}], 'seeAlsoLinks': [{'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}]}, 'descriptionModule': {'briefSummary': "Human papillomavirus infection has clearly been recognized as the cause of cervical cancer. The infection of the cervix by certain oncogenic types of HPV, if not cleared, can lead to cervical cancer in women. This study will evaluate the immunogenicity and safety of the GSK Biologicals' HPV-16/18 L1 VLP AS04 vaccine (Cervarix TM) vaccine.\n\nThe Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who the investigator believes that they or their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.\n* A female between, and including, 15 and 25 years of age at the time of the first vaccination.\n* Written informed assent obtained from the subject and informed consent obtained from the parent or guardian of the subject.\n* Healthy subjects as established by medical history and clinical examination before entering into the study.\n* Subjects must have a negative urine pregnancy test.\n* Subjects of childbearing potential at the time of study entry must be abstinent, or must be using adequate contraceptive precautions for 30 days prior to vaccination and must agree to continue such precautions for two months after completion of the vaccination series.\n\nExclusion Criteria:\n\n* Use of any investigational or non-registered product (drug or vaccine) other than the study/ control vaccine within 30 days preceding the first dose of study/ control vaccine, or planned use during the study period.\n* Pregnant or breastfeeding.\n* Planning to become pregnant or likely to become pregnant.\n* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.\n* Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after the first dose of vaccine. However, the administration of routine vaccines up to 8 days before the first dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window.\n* Previous administration of components of the investigational vaccine\n* Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period.\n* Any medically diagnosed or suspected immunodeficient condition such as HIV infection based on medical history and physical examination.\n* History of thrombocytopenia or hemostatic disorder in which case the study vaccine should under no circumstances be administered intramuscularly.\n* History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study/control vaccines.\n* Hypersensitivity to latex.\n* Known acute or chronic, clinically significant neurologic, pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests.\n* History of chronic condition(s) requiring treatment.\n* Administration of immunoglobulins and/or any blood product within three months preceding the first dose of study/control vaccine or planned administration during the study period. Enrolment will be deferred until the subject is outside of specified window.\n* Acute disease at the time of enrolment.'}, 'identificationModule': {'nctId': 'NCT00485732', 'briefTitle': "A Study to Evaluate the Immune Response and Safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine/Cervarix TM Vaccine in Healthy Females Aged 15-25 Years", 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "A Phase IIIb, Double-blind, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV-16/18 L1 VLP AS04 Vaccine, Administered Intramuscularly in Healthy Female Subjects Aged 15 - 25 Years", 'orgStudyIdInfo': {'id': '107291'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cervarix Group', 'interventionNames': ['Biological: HPV-16/18 VLP/AS04 vaccine (Cervarix TM)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'HPV-16/18 VLP/AS04 vaccine (Cervarix TM)', 'type': 'BIOLOGICAL', 'otherNames': ["GSK Biologicals' HPV-16/18 VLP/AS04 vaccine"], 'description': 'Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.', 'armGroupLabels': ['Cervarix Group']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Three doses of placebo administered intramuscularly according to a 0, 1, 6-month schedule.', 'armGroupLabels': ['Placebo Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '137-040', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '138-736', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '150-879', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '158-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}