Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2025-12-27 @ 4:27 AM
Study NCT ID:
NCT00128661
Status:
COMPLETED
Last Update Posted:
2019-03-08
First Post:
2005-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Vaccine To Prevent Cervical Intraepithelial Neoplasia or Cervical Cancer in Younger Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D002578', 'term': 'Uterine Cervical Dysplasia'}], 'ancestors': [{'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'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, '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}, 'limitationsAndCaveats': {'description': 'The following analysis "occurence of histopathologically confirmed CIN2+ cases associated with HPV16 or HPV18 infection was not performed, in accordance with the Statistical Analysis Plan submitted to the FDA.'}}, 'adverseEventsModule': {'timeFrame': 'Solicited AEs: within 60 minutes after vaccination for all participants [please refer to Participant Flow Pre-assignment Details for population description]; From Day 3 to Day 6 post-vaccination for a 10% random subset of participants. SAEs: From Month 0 up to Month 48. Unsolicited AEs: From Month 0 up to Month 48 and Within 30 days (Days 0-29) after vaccination', 'description': "For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.", 'eventGroups': [{'id': 'EG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.', 'otherNumAtRisk': 3730, 'otherNumAffected': 1627, 'seriousNumAtRisk': 3727, 'seriousNumAffected': 912}, {'id': 'EG001', 'title': 'Havrix Group', 'description': 'Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.', 'otherNumAtRisk': 3740, 'otherNumAffected': 1610, 'seriousNumAtRisk': 3739, 'seriousNumAffected': 891}], 'otherEvents': [{'term': 'Pain', 'notes': 'Within 60 minutes after vaccination.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3730, 'numAffected': 1627}, {'groupId': 'EG001', 'numAtRisk': 3740, 'numAffected': 1610}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Redness', 'notes': 'Within 60 minutes after vaccination.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3730, 'numAffected': 544}, {'groupId': 'EG001', 'numAtRisk': 3740, 'numAffected': 501}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Swelling', 'notes': 'Within 60 minutes after vaccination.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3730, 'numAffected': 207}, {'groupId': 'EG001', 'numAtRisk': 3740, 'numAffected': 201}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'notes': 'Within 60 minutes after vaccination.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3730, 'numAffected': 512}, {'groupId': 'EG001', 'numAtRisk': 3740, 'numAffected': 502}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myalgia', 'notes': 'Within 60 minutes after vaccination.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3730, 'numAffected': 257}, {'groupId': 'EG001', 'numAtRisk': 3740, 'numAffected': 232}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal', 'notes': 'Within 60 minutes after vaccination.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3730, 'numAffected': 191}, {'groupId': 'EG001', 'numAtRisk': 3740, 'numAffected': 171}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'notes': 'Within 60 minutes after vaccination.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3730, 'numAffected': 714}, {'groupId': 'EG001', 'numAtRisk': 3740, 'numAffected': 718}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'notes': 'Within 60 minutes after vaccination.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3730, 'numAffected': 472}, {'groupId': 'EG001', 'numAtRisk': 3740, 'numAffected': 477}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'notes': 'From Day 3 to Day 6 post-vaccination, in a 10% random subset of participants.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 202}, {'groupId': 'EG001', 'numAtRisk': 376, 'numAffected': 74}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Swelling', 'notes': 'From Day 3 to Day 6 post-vaccination, in a 10% random subset of participants.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 376, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'notes': 'From Day 3 to Day 6 post-vaccination, in a 10% random subset of participants.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 214}, {'groupId': 'EG001', 'numAtRisk': 376, 'numAffected': 189}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myalgia', 'notes': 'From Day 3 to Day 6 post-vaccination, in a 10% random subset of participants.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 250}, {'groupId': 'EG001', 'numAtRisk': 376, 'numAffected': 211}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'notes': 'From Day 3 to Day 6 post-vaccination, in a 10% random subset of participants.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 376, 'numAffected': 32}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal', 'notes': 'From Day 3 to Day 6 post-vaccination, in a 10% random subset of participants.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 157}, {'groupId': 'EG001', 'numAtRisk': 376, 'numAffected': 119}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'notes': 'From Day 3 to Day 6 post-vaccination, in a 10% random subset of participants.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 247}, {'groupId': 'EG001', 'numAtRisk': 376, 'numAffected': 242}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'notes': 'From Day 3 to Day 6 post-vaccination, in a 10% random subset of participants.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 376, 'numAffected': 26}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'notes': 'From Day 3 to Day 6 post-vaccination, in a 10% random subset of participants.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 380, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 376, 'numAffected': 37}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Influenza', 'notes': 'Within 30 days (Days 0-29) after vaccination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 263}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 293}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Myalgia', 'notes': 'Within 30 days (Days 0-29) after vaccination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 355}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 166}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'notes': 'Within 30 days (Days 0-29) after vaccination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 218}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 214}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Menstruation irregular', 'notes': 'From Month 0 up to Month 48', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 1021}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 1011}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Influenza', 'notes': 'From Month 0 up to Month 48', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 903}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 950}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vaginal infection', 'notes': 'From Month 0 up to Month 48', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 709}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 763}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vulvovaginal candidiasis', 'notes': 'From Month 0 up to Month 48', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 714}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 678}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'notes': 'From Month 0 up to Month 48', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 555}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 565}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'notes': 'From Month 0 up to Month 48', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 324}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 327}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'notes': 'From Month 0 up to Month 48', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 324}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 315}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Myalgia', 'notes': 'From Month 0 up to Month 48', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 386}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 189}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal inflammation', 'notes': 'From Month 0 up to Month 48', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 263}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 249}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dengue fever', 'notes': 'From Month 0 up to Month 48', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 174}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 190}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Abortion spontaneous incomplete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 134}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 108}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'False labour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 88}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abortion spontaneous complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 64}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abortion missed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 63}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Foetal distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 64}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Caesarean section', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 59}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Uterine hypotonus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 54}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gestational hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 53}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dengue fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 48}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abortion threatened', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 37}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cephalo-pelvic disproportion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 45}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Breech presentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 33}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anaemia of pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 22}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 19}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pre-eclampsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 23}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Failed induction of labour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 20}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Complication of pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 19}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Intentional self-injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 17}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Intra-uterine death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 18}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Foetal growth restriction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 14}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 9}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Premature rupture of membranes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 19}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Obstructed labour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 15}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abnormal product of conception', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 11}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ectopic pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 14}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Postpartum haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 7}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Postpartum sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Oligohydramnios', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 8}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Benign ovarian tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 7}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Premature separation of placenta', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 10}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperemesis gravidarum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 8}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Multiple injuries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 10}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gestational diabetes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 6}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Multiple pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 2}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Placenta praevia haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 4}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 5}], 'organSystem': 'Infections 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connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Intracranial hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Intrapartum haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Jaw fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Malaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Mastitis postpartum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Medical observation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Meningitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Multiple congenital abnormalities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal sinus cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Neonatal respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': "Non-Hodgkin's lymphoma", 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ovarian torsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ovulation pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pancreatitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pelvic haematoma obstetric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Peritoneal adhesions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Peritoneal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pilonidal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Placental disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Placental neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Polycystic ovaries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Polymenorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Post abortion haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Post procedural infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Postpartum disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Previous caesarean section', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Prolonged labour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Prolonged pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyoderma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Retinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rhesus incompatibility', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sexual abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Strabismus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Syphilis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tendon injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tenosynovitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Therapeutic procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tooth ankylosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tooth development disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tooth malformation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Toxic skin eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Twin pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ulcerative keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Uterine inversion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Varicella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Varicophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vascular headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vulval abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vulval neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3727, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3739, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Cases Associated With HPV16 and/or HPV18 Infection Detected in the Preceding Cervical Cytology Specimen.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2635', 'groupId': 'OG000'}, {'value': '2677', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Havrix Group', 'description': 'Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.'}], 'classes': [{'title': 'HPV16 Associated CIN2+ (N=2464;2452)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'HPV18 Associated CIN2+ (N=2567; 2593)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'HPV16 and/or 18 Associated CIN2+ (N=2635;2677)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Month 6 up to Month 48', 'description': 'CIN2+ was defined as CIN grade 2 (CIN2), CIN grade 3 (CIN3), adenocarcinoma in situ (AIS) or invasive cervical cancer. Preceding cervical cytology means the last cervical cytology specimen collected before the histopathology specimen was obtained. Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) by polymerase chain reaction (PCR) at Month 0 and Month 6 for the corresponding HPV-type.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'The According-To-Protocol (ATP) cohort for efficacy included subjects with efficacy data available, who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and at the time of administration of the 3rd dose (Month 6) and who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6).'}, {'type': 'SECONDARY', 'title': 'Number of Cervical Infection With HPV16 or HPV18.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2635', 'groupId': 'OG000'}, {'value': '2677', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Havrix Group', 'description': 'Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.'}], 'classes': [{'title': 'HPV16 Cervical Infection (N=2464;2452)', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}]}]}, {'title': 'HPV18 Cervical Infection (N=2567;2593)', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}]}]}, {'title': 'HPV16 and/or 18 Cervical Infection (N=2635;2677)', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '387', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Month 6 up to Month 48', 'description': 'Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'The According-To-Protocol (ATP) cohort for efficacy included subjects with efficacy data available, who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and at the time of administration of the 3rd dose (Month 6) and who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6).'}, {'type': 'SECONDARY', 'title': 'Number of Histopathologically Confirmed CIN2+ Cases Associated With Infection by Any Oncogenic HPV Type', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2643', 'groupId': 'OG000'}, {'value': '2697', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Havrix Group', 'description': 'Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.'}], 'classes': [{'title': 'HPV16 Associated CIN2+ (N=2464;2452)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'HPV18 Associated CIN2+ (N=2567,2593)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'HPV31 Associated CIN2+ (N=2525;2546)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'HPV33 Associated CIN2+ (N=2596;2645)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'HPV35 Associated CIN2+ (N=2593;2631)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'HPV39 Associated CIN2+ (N=2528;2581)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HPV45 Associated CIN2+ (N=2573;2622)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'HPV51 Associated CIN2+ (N=2453;2539)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'HPV52 Associated CIN2+ (N=2456;2505)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'HPV56 Associated CIN2+ (N=2524;2564)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'HPV58 Associated CIN2+ (N=2551;2595)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'HPV59 Associated CIN2+ (N=2576;2637)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'HPV68 and/or 73 Associated CIN2+ (N=2519;2576)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Non 16/18 Onco HPV Associated CIN2+ (N=2643;2697)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Any Oncogenic HPV Associated CIN2+ (N=2643;2697)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Month 6 up to Month 48', 'description': 'Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68 detected by polymerase chain reaction (PRC) in the preceding cervical cytology specimen. Note: The assay did not distinguish between HPV types 68 and 73. CIN2+ was defined as CIN grade 2 (CIN2), CIN grade 3 (CIN3), adenocarcinoma in situ (AIS) or invasive cervical cancer Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'The According-To-Protocol (ATP) cohort for efficacy included subjects with efficacy data available, who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and at the time of administration of the 3rd dose (Month 6) and who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6).'}, {'type': 'SECONDARY', 'title': 'Number of Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 Cases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2635', 'groupId': 'OG000'}, {'value': '2677', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Havrix Group', 'description': 'Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.'}], 'classes': [{'title': 'Persistent HPV16 Infection (N=2464,2452)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}]}, {'title': 'Persistent HPV18 Infection (N=2567;2593)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'Persistent HPV16 and/or 18 Infection (N=2635;2677)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Month 6 up to Month 48', 'description': 'Persistent incident HPV-16 and /or HPV-18 cervical infection had to fulfil the following criteria: first detection after the 6-month visit, 2 same type HPV positive (by PCR) test results 10+ months apart, and no intervening HPV negative tests for the corresponding type. Persistent HPV16 or HPV18 cervical infection = detection of the same HPV type by polymerase chain reaction (PCR) in cervical samples from all consecutive evaluations over approximately 12 months. Subjects were HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'The According-To-Protocol (ATP) cohort for efficacy included subjects with efficacy data available, who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and at the time of administration of the 3rd dose (Month 6) and who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6).'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titers (GMTs) for HPV-16 Antibody in the Immunogenicity Subcohort.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Havrix Group', 'description': 'Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.'}], 'classes': [{'title': 'HPV-16 [before vaccination] (N=194;156)', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000', 'lowerLimit': '5.7', 'upperLimit': '7.8'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '6.7', 'upperLimit': '10.0'}]}]}, {'title': 'HPV-16 [at Month 1] (N=196,157)', 'categories': [{'measurements': [{'value': '646.6', 'groupId': 'OG000', 'lowerLimit': '549.3', 'upperLimit': '761.1'}, {'value': '7.9', 'groupId': 'OG001', 'lowerLimit': '6.5', 'upperLimit': '9.6'}]}]}, {'title': 'HPV-16 [at Month 6] (N=195,156)', 'categories': [{'measurements': [{'value': '771.5', 'groupId': 'OG000', 'lowerLimit': '668.3', 'upperLimit': '890.7'}, {'value': '8.4', 'groupId': 'OG001', 'lowerLimit': '6.9', 'upperLimit': '10.3'}]}]}, {'title': 'HPV-16 [at Month 7] (N=195,157)', 'categories': [{'measurements': [{'value': '3261', 'groupId': 'OG000', 'lowerLimit': '2959', 'upperLimit': '3595'}, {'value': '8.5', 'groupId': 'OG001', 'lowerLimit': '6.9', 'upperLimit': '10.3'}]}]}, {'title': 'HPV-16 [at Month 12] (N=182,146)', 'categories': [{'measurements': [{'value': '2090', 'groupId': 'OG000', 'lowerLimit': '1822', 'upperLimit': '2398'}, {'value': '8.3', 'groupId': 'OG001', 'lowerLimit': '6.7', 'upperLimit': '10.4'}]}]}, {'title': 'HPV-16 [at Month 18] (N=25,17)', 'categories': [{'measurements': [{'value': '1045', 'groupId': 'OG000', 'lowerLimit': '776.0', 'upperLimit': '1408'}, {'value': '10.4', 'groupId': 'OG001', 'lowerLimit': '4.8', 'upperLimit': '22.7'}]}]}, {'title': 'HPV-16 [at Month 24] (N=175,137)', 'categories': [{'measurements': [{'value': '1486', 'groupId': 'OG000', 'lowerLimit': '1293', 'upperLimit': '1709'}, {'value': '8.6', 'groupId': 'OG001', 'lowerLimit': '6.9', 'upperLimit': '10.7'}]}]}, {'title': 'HPV-16 [at Month 30] (N=19,15)', 'categories': [{'measurements': [{'value': '1070', 'groupId': 'OG000', 'lowerLimit': '747.5', 'upperLimit': '1532'}, {'value': '11.9', 'groupId': 'OG001', 'lowerLimit': '5.1', 'upperLimit': '28.0'}]}]}, {'title': 'HPV-16 [at Month 36] (N=163,132)', 'categories': [{'measurements': [{'value': '1256', 'groupId': 'OG000', 'lowerLimit': '1080', 'upperLimit': '1461'}, {'value': '9.0', 'groupId': 'OG001', 'lowerLimit': '7.4', 'upperLimit': '11.0'}]}]}, {'title': 'HPV-16 [at Month 42] (N=22,18)', 'categories': [{'measurements': [{'value': '1259', 'groupId': 'OG000', 'lowerLimit': '879.4', 'upperLimit': '1802'}, {'value': '6.1', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '9.4'}]}]}, {'title': 'HPV-16 [at Month 48] (N=172,131)', 'categories': [{'measurements': [{'value': '1155', 'groupId': 'OG000', 'lowerLimit': '1009', 'upperLimit': '1322'}, {'value': '9.5', 'groupId': 'OG001', 'lowerLimit': '7.7', 'upperLimit': '11.7'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48', 'description': 'Titers were assessed for the 600 subjects enrolled into the immunogenicity subcohort by Enzyme linked immunosorbent assay (ELISA) and expressed as geometric mean titers (GMTs). Seronegative subjects = antibody concentration below 8 ELISA Units per millilitre (EL.U/mL) prior to vaccination. Seropositive subjects=antibody concentration equal to or above 8 EL.U/mL prior to vaccination. Immunogenicity subcohort = subset of 600 subjects from the 2 groups of the ATP cohort: subjects attended 1 extra clinic visit approximately 1 month (30 to 60 days) after the last dose was administered (Month 7)', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ATP cohort for immunogenicity included subjects who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and during the 48-month follow-up period, who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6) and for whom immunogenicity results were available.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titers (GMTs) for HPV-18 Antibody in the Immunogenicity Subcohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Havrix Group', 'description': 'Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.'}], 'classes': [{'title': 'HPV-18 [before vaccination] (N=200;173)', 'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000', 'lowerLimit': '4.8', 'upperLimit': '6.1'}, {'value': '6.2', 'groupId': 'OG001', 'lowerLimit': '5.2', 'upperLimit': '7.4'}]}]}, {'title': 'HPV-18 [at Month 1] (N=203;170)', 'categories': [{'measurements': [{'value': '372.7', 'groupId': 'OG000', 'lowerLimit': '322.8', 'upperLimit': '430.3'}, {'value': '6.4', 'groupId': 'OG001', 'lowerLimit': '5.4', 'upperLimit': '7.6'}]}]}, {'title': 'HPV-18 [at Month 6] (N=203;175)', 'categories': [{'measurements': [{'value': '532.2', 'groupId': 'OG000', 'lowerLimit': '467.5', 'upperLimit': '605.9'}, {'value': '6.7', 'groupId': 'OG001', 'lowerLimit': '5.6', 'upperLimit': '7.9'}]}]}, {'title': 'HPV-18 [at Month 7] (N=202;175)', 'categories': [{'measurements': [{'value': '3276', 'groupId': 'OG000', 'lowerLimit': '3001', 'upperLimit': '3576'}, {'value': '6.8', 'groupId': 'OG001', 'lowerLimit': '5.7', 'upperLimit': '8.1'}]}]}, {'title': 'HPV-18 [at Month 12] (N=190;166)', 'categories': [{'measurements': [{'value': '1082', 'groupId': 'OG000', 'lowerLimit': '942.0', 'upperLimit': '1242'}, {'value': '7.0', 'groupId': 'OG001', 'lowerLimit': '5.7', 'upperLimit': '8.5'}]}]}, {'title': 'HPV-18 [at Month 18] (N=28;20)', 'categories': [{'measurements': [{'value': '502.4', 'groupId': 'OG000', 'lowerLimit': '339.1', 'upperLimit': '744.5'}, {'value': '6.7', 'groupId': 'OG001', 'lowerLimit': '3.8', 'upperLimit': '12.1'}]}]}, {'title': 'HPV-18 [at Month 24] (N=178;150)', 'categories': [{'measurements': [{'value': '633.0', 'groupId': 'OG000', 'lowerLimit': '551.5', 'upperLimit': '726.6'}, {'value': '6.9', 'groupId': 'OG001', 'lowerLimit': '5.6', 'upperLimit': '8.4'}]}]}, {'title': 'HPV-18 [at Month 30] (N=17;19)', 'categories': [{'measurements': [{'value': '403.8', 'groupId': 'OG000', 'lowerLimit': '257.8', 'upperLimit': '632.5'}, {'value': '6.4', 'groupId': 'OG001', 'lowerLimit': '3.8', 'upperLimit': '10.5'}]}]}, {'title': 'HPV-18 [at Month 36] (N=168;145)', 'categories': [{'measurements': [{'value': '519.7', 'groupId': 'OG000', 'lowerLimit': '449.3', 'upperLimit': '601.1'}, {'value': '6.0', 'groupId': 'OG001', 'lowerLimit': '5.0', 'upperLimit': '7.2'}]}]}, {'title': 'HPV-18 [at Month 42] (N=25;19)', 'categories': [{'measurements': [{'value': '582.4', 'groupId': 'OG000', 'lowerLimit': '422.9', 'upperLimit': '801.9'}, {'value': '5.5', 'groupId': 'OG001', 'lowerLimit': '3.6', 'upperLimit': '8.4'}]}]}, {'title': 'HPV-18 [at Month 48] (N=179;149)', 'categories': [{'measurements': [{'value': '470.1', 'groupId': 'OG000', 'lowerLimit': '411.2', 'upperLimit': '537.4'}, {'value': '6.6', 'groupId': 'OG001', 'lowerLimit': '5.5', 'upperLimit': '8.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48', 'description': 'Titers were assessed for the 600 subjects enrolled into the immunogenicity subcohortby Enzyme linked immunosorbent assay (ELISA) and expressed as geometric mean titers (GMTs). Seronegative (Sero-) subjects=antibody concentration below 7 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects=antibody concentration equal to or above 7 EL.U/mL prior to vaccination. Immunogenicity subcohort=subset of 600 subjects from the 2 groups of the ATP cohort: subjects attended 1 extra clinic visit approximately 1 month (30 to 60 days) after the last dose was administered (Month 7).', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ATP cohort for immunogenicity included subjects who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and during the 48-month follow-up period, who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6) and for whom immunogenicity results were available.'}, {'type': 'SECONDARY', 'title': 'HPV-16 Geometric Mean Titers (GMTs) (V5 Monoclonal Antibody Inhibition Test)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Havrix Group', 'description': 'Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.'}], 'classes': [{'title': 'HPV-16 [before vaccination] (N=196;158)', 'categories': [{'measurements': [{'value': '21.1', 'groupId': 'OG000', 'lowerLimit': '20.5', 'upperLimit': '21.8'}, {'value': '21.4', 'groupId': 'OG001', 'lowerLimit': '20.6', 'upperLimit': '22.3'}]}]}, {'title': 'HPV-16 [at Month 1] (N=182;155)', 'categories': [{'measurements': [{'value': '58.5', 'groupId': 'OG000', 'lowerLimit': '48.3', 'upperLimit': '70.8'}, {'value': '21.5', 'groupId': 'OG001', 'lowerLimit': '20.7', 'upperLimit': '22.3'}]}]}, {'title': 'HPV-16 [at Month 6] (N=189;156)', 'categories': [{'measurements': [{'value': '80.9', 'groupId': 'OG000', 'lowerLimit': '70.3', 'upperLimit': '93.1'}, {'value': '21.5', 'groupId': 'OG001', 'lowerLimit': '20.6', 'upperLimit': '22.4'}]}]}, {'title': 'HPV-16 [at Month 7] (N=193;158)', 'categories': [{'measurements': [{'value': '1047', 'groupId': 'OG000', 'lowerLimit': '926.3', 'upperLimit': '1183'}, {'value': '21.4', 'groupId': 'OG001', 'lowerLimit': '20.6', 'upperLimit': '22.3'}]}]}, {'title': 'HPV-16 [at Month 12] (N=175;146)', 'categories': [{'measurements': [{'value': '291.4', 'groupId': 'OG000', 'lowerLimit': '253.7', 'upperLimit': '334.8'}, {'value': '22.6', 'groupId': 'OG001', 'lowerLimit': '20.8', 'upperLimit': '24.5'}]}]}, {'title': 'HPV-16 [at Month 18] (N=24;17)', 'categories': [{'measurements': [{'value': '116.6', 'groupId': 'OG000', 'lowerLimit': '83.2', 'upperLimit': '163.3'}, {'value': '20.5', 'groupId': 'OG001', 'lowerLimit': '20.5', 'upperLimit': '20.5'}]}]}, {'title': 'HPV-16 [at Month 24] (N=169;138)', 'categories': [{'measurements': [{'value': '184.6', 'groupId': 'OG000', 'lowerLimit': '163.0', 'upperLimit': '209.1'}, {'value': '21.4', 'groupId': 'OG001', 'lowerLimit': '20.6', 'upperLimit': '22.3'}]}]}, {'title': 'HPV-16 [at Month 30] (N=18;15)', 'categories': [{'measurements': [{'value': '112.4', 'groupId': 'OG000', 'lowerLimit': '78.7', 'upperLimit': '160.6'}, {'value': '20.5', 'groupId': 'OG001', 'lowerLimit': '20.5', 'upperLimit': '20.5'}]}]}, {'title': 'HPV-16 [at Month 36] (N=162;132)', 'categories': [{'measurements': [{'value': '139.7', 'groupId': 'OG000', 'lowerLimit': '122.5', 'upperLimit': '159.5'}, {'value': '20.8', 'groupId': 'OG001', 'lowerLimit': '20.2', 'upperLimit': '21.3'}]}]}, {'title': 'HPV-16 [at Month 42] (N=22;18)', 'categories': [{'measurements': [{'value': '126.9', 'groupId': 'OG000', 'lowerLimit': '89.9', 'upperLimit': '179.1'}, {'value': '20.5', 'groupId': 'OG001', 'lowerLimit': '20.5', 'upperLimit': '20.5'}]}]}, {'title': 'HPV-16 [at Month 48] (N=168;133)', 'categories': [{'measurements': [{'value': '131.8', 'groupId': 'OG000', 'lowerLimit': '115.5', 'upperLimit': '150.5'}, {'value': '21.0', 'groupId': 'OG001', 'lowerLimit': '20.4', 'upperLimit': '21.7'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48', 'description': 'Titers were assessed for the 600 subjects enrolled into the immunogenicity subcohort by Inhibition Enzyme Immunoassay (EIA) and expressed as geometric mean antibody titers (GMTs). Seronegative (Sero-) subjects=antibody concentration below 41 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects=antibody concentration equal to or above 41 EL.U/mL prior to vaccination. Immunogenicity subcohort=subset of 600 subjects from the 2 groups of the ATP cohort: subjects attended 1 extra clinic visit approximately 1 month (30 to 60 days) after the last dose was administered (Month 7).', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ATP cohort for immunogenicity included subjects who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and during the 48-month follow-up period, who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6) and for whom immunogenicity results were available.'}, {'type': 'SECONDARY', 'title': 'HPV-18 Geometric Mean Titers (GMTs) (J4 Monoclonal Antibody Inhibition Test)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Havrix Group', 'description': 'Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.'}], 'classes': [{'title': 'HPV-18 [before vaccination] (N=203;176)', 'categories': [{'measurements': [{'value': '55.0', 'groupId': 'OG000', 'lowerLimit': '55.0', 'upperLimit': '55.0'}, {'value': '55.7', 'groupId': 'OG001', 'lowerLimit': '54.7', 'upperLimit': '56.7'}]}]}, {'title': 'HPV-18 [at Month 1] (N=197;173)', 'categories': [{'measurements': [{'value': '99.1', 'groupId': 'OG000', 'lowerLimit': '88.0', 'upperLimit': '111.5'}, {'value': '55.3', 'groupId': 'OG001', 'lowerLimit': '54.7', 'upperLimit': '55.8'}]}]}, {'title': 'HPV-18 [at Month 6] (N=195;175)', 'categories': [{'measurements': [{'value': '111.4', 'groupId': 'OG000', 'lowerLimit': '100.2', 'upperLimit': '123.9'}, {'value': '55.4', 'groupId': 'OG001', 'lowerLimit': '54.6', 'upperLimit': '56.3'}]}]}, {'title': 'HPV-18 [at Month 7] (N=198;176)', 'categories': [{'measurements': [{'value': '823.6', 'groupId': 'OG000', 'lowerLimit': '737.7', 'upperLimit': '919.5'}, {'value': '55.0', 'groupId': 'OG001', 'lowerLimit': '55.0', 'upperLimit': '55.0'}]}]}, {'title': 'HPV-18 [at Month 12] (N=182;166)', 'categories': [{'measurements': [{'value': '231.1', 'groupId': 'OG000', 'lowerLimit': '203.2', 'upperLimit': '262.7'}, {'value': '56.7', 'groupId': 'OG001', 'lowerLimit': '54.7', 'upperLimit': '58.8'}]}]}, {'title': 'HPV-18 [at Month 18] (N=28;20)', 'categories': [{'measurements': [{'value': '121.8', 'groupId': 'OG000', 'lowerLimit': '89.5', 'upperLimit': '165.8'}, {'value': '55.0', 'groupId': 'OG001', 'lowerLimit': '55.0', 'upperLimit': '55.0'}]}]}, {'title': 'HPV-18 [at Month 24] (N=170;154)', 'categories': [{'measurements': [{'value': '140.8', 'groupId': 'OG000', 'lowerLimit': '123.8', 'upperLimit': '160.2'}, {'value': '55.0', 'groupId': 'OG001', 'lowerLimit': '55.0', 'upperLimit': '55.0'}]}]}, {'title': 'HPV-18 [at Month 30] (N=17;19)', 'categories': [{'measurements': [{'value': '89.5', 'groupId': 'OG000', 'lowerLimit': '67.6', 'upperLimit': '118.7'}, {'value': '55.0', 'groupId': 'OG001', 'lowerLimit': '55.0', 'upperLimit': '55.0'}]}]}, {'title': 'HPV-18 [at Month 36] (N=167;145)', 'categories': [{'measurements': [{'value': '107.9', 'groupId': 'OG000', 'lowerLimit': '96.0', 'upperLimit': '121.2'}, {'value': '55.0', 'groupId': 'OG001', 'lowerLimit': '55.0', 'upperLimit': '55.0'}]}]}, {'title': 'HPV-18 [at Month 42] (N=25;19)', 'categories': [{'measurements': [{'value': '103.3', 'groupId': 'OG000', 'lowerLimit': '80.3', 'upperLimit': '132.9'}, {'value': '55.0', 'groupId': 'OG001', 'lowerLimit': '55.0', 'upperLimit': '55.0'}]}]}, {'title': 'HPV-18 [at Month 48 (N=179;150)', 'categories': [{'measurements': [{'value': '96.9', 'groupId': 'OG000', 'lowerLimit': '87.7', 'upperLimit': '107.0'}, {'value': '56.7', 'groupId': 'OG001', 'lowerLimit': '54.0', 'upperLimit': '59.6'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48', 'description': 'Titers were assessed for the 600 subjects enrolled into the immunogenicity subcohort by Inhibition Enzyme Immunoassay (EIA) and expressed as geometric mean antibody titers (GMTs). Seronegative (Sero-) subjects=antibody concentration below 110 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects=antibody concentration equal to or above 110 EL.U/mL prior to vaccination. Immunogenicity subcohort=subset of 600 subjects from the 2 groups of the ATP cohort: subjects attended 1 extra clinic visit approximately 1 month (30 to 60 days) after the last dose was administered (Month 7).', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ATP cohort for immunogenicity included subjects who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and during the 48-month follow-up period, who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6) and for whom immunogenicity results were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3730', 'groupId': 'OG000'}, {'value': '3740', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Havrix Group', 'description': 'Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.'}], 'classes': [{'title': 'Any pain', 'categories': [{'measurements': [{'value': '1627', 'groupId': 'OG000'}, {'value': '1610', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 pain', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Any redness', 'categories': [{'measurements': [{'value': '544', 'groupId': 'OG000'}, {'value': '501', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 redness > 50 mm', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any swelling', 'categories': [{'measurements': [{'value': '207', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 swelling > 50 mm', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 60 minutes after vaccination', 'description': 'Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities as assessed by inability to attend work or school and which necessitated the administration of corrective therapy. Grade 3 redness and swelling was defined as redness/swelling above 50 millimeter (mm).', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3730', 'groupId': 'OG000'}, {'value': '3740', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Havrix Group', 'description': 'Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.'}], 'classes': [{'title': 'Any fatigue', 'categories': [{'measurements': [{'value': '512', 'groupId': 'OG000'}, {'value': '502', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 fatigue', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Any myalgia', 'categories': [{'measurements': [{'value': '257', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 myalgia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any arthralgia', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 arthralgia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any gastrointestinal', 'categories': [{'measurements': [{'value': '191', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 gastrointestinal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any headache', 'categories': [{'measurements': [{'value': '714', 'groupId': 'OG000'}, {'value': '718', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 headache', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any rash', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 rash', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any urticaria', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 urticaria', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Fever (oral) >= 37.5°C', 'categories': [{'measurements': [{'value': '472', 'groupId': 'OG000'}, {'value': '477', 'groupId': 'OG001'}]}]}, {'title': 'Fever (oral) > 39.0°C', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 60 minutes after vaccination', 'description': 'Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (Fever = oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal everyday activities as assessed by inability to attend work or school and which necessitated the administration of corrective therapy.Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = oral temperature \\> 39.0°C.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms on a 10% Random Subset of Participants.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Havrix Group', 'description': 'Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.'}], 'classes': [{'title': 'Any pain', 'categories': [{'measurements': [{'value': '202', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 pain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any redness', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 redness', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any swelling', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 swelling', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 3 to Day 6 after vaccination', 'description': 'Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities as assessed by inability to attend work or school and which necessitated the administration of corrective therapy. Grade 3 redness and swelling was defined as redness/swelling above 50 millimeter (mm).', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms on a 10% Random Subset of Participants.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Havrix Group', 'description': 'Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.'}], 'classes': [{'title': 'Any pain', 'categories': [{'measurements': [{'value': '214', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 pain', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any myalgia', 'categories': [{'measurements': [{'value': '250', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 myalgia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any arthralgia', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 arthralgia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any gastrointestinal', 'categories': [{'measurements': [{'value': '157', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 gastrointestinal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any headache', 'categories': [{'measurements': [{'value': '247', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 headache', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any rash', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 rash', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any urticaria', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 urticaria', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Fever (oral) >= 37.5°C', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'Fever (oral) > 39.0°C', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 3 to Day 6 after vaccination', 'description': 'Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (Fever = oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal everyday activities as assessed by inability to attend work or school and which necessitated the administration of corrective therapy.Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = oral temperature \\> 39.0°C.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Serious Adverse Events (SAEs).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3727', 'groupId': 'OG000'}, {'value': '3739', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Havrix Group', 'description': 'Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '912', 'groupId': 'OG000'}, {'value': '891', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the entire study period (From Month 0 up to Month 48).', 'description': 'SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Unsolicited Adverse Events (AEs).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3727', 'groupId': 'OG000'}, {'value': '3739', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Havrix Group', 'description': 'Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '3228', 'groupId': 'OG000'}, {'value': '3254', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the entire study period (From Month 0 up to Month 48).', 'description': 'An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With All Possible Pregnancy Outcomes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2123', 'groupId': 'OG000'}, {'value': '2129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Havrix Group', 'description': 'Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.'}], 'classes': [{'title': 'Pregnancy loss', 'categories': [{'measurements': [{'value': '317', 'groupId': 'OG000'}, {'value': '294', 'groupId': 'OG001'}]}]}, {'title': 'Pregnancy resolved alive', 'categories': [{'measurements': [{'value': '1756', 'groupId': 'OG000'}, {'value': '1766', 'groupId': 'OG001'}]}]}, {'title': 'Unresolved pregnancy', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the entire study period (From Month 0 up to Month 48).', 'description': 'The range of possible pregnancy outcomes was: Pregnancy loss, Pregnancy resolved alive, and Unresolved pregnancy.', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated Cohort, on all pregnant subjects.'}, {'type': 'SECONDARY', 'title': 'Number of Cervical Infection With HPV16 or HPV18.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2380', 'groupId': 'OG000'}, {'value': '2420', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Havrix Group', 'description': 'Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.'}], 'classes': [{'title': 'HPV16 Cervical Infection (N=2242;2232)', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'HPV18 Cervical Infection (N=2330;2347)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'HPV16 and/or 18 Cervical Infection (N=2380;2420)', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the first year of follow-up period', 'description': 'Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'The According-To-Protocol (ATP) cohort for efficacy included subjects with efficacy data available, who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and at the time of administration of the 3rd dose (Month 6) and who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6).'}, {'type': 'SECONDARY', 'title': 'Number of Cervical Infection With HPV16 or HPV18.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2313', 'groupId': 'OG000'}, {'value': '2349', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Havrix Group', 'description': 'Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.'}], 'classes': [{'title': 'HPV16 Cervical Infection (N=2170;2176)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}]}, {'title': 'HPV18 Cervical Infection (N=2269;2307)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'HPV16 and/or 18 Cervical Infection (N=2313;2349)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the second year of follow-up period', 'description': 'Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'The According-To-Protocol (ATP) cohort for efficacy included subjects with efficacy data available, who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and at the time of administration of the 3rd dose (Month 6) and who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6).'}, {'type': 'SECONDARY', 'title': 'Number of Cervical Infection With HPV16 or HPV18.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2232', 'groupId': 'OG000'}, {'value': '2196', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Havrix Group', 'description': 'Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.'}], 'classes': [{'title': 'HPV16 Cervical Infection (N=2097;2026)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}, {'title': 'HPV18 Cervical Infection (N=2200;2196)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'HPV16 and/or 18 Cervical Infection (N=2236;2166)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the third year of follow-up period', 'description': 'Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'The According-To-Protocol (ATP) cohort for efficacy included subjects with efficacy data available, who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and at the time of administration of the 3rd dose (Month 6) and who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6).'}, {'type': 'SECONDARY', 'title': 'Number of Cervical Infection With HPV16 or HPV18.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2421', 'groupId': 'OG000'}, {'value': '2325', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Havrix Group', 'description': 'Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.'}], 'classes': [{'title': 'HPV16 Cervical Infection (N=2277;2139)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}]}, {'title': 'HPV18 Cervical Infection (N=2389;2325)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}, {'title': 'HPV16 and/or 18 Cervical Infection (N=2421;2261)', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the fourth year follow-up period', 'description': 'Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'The According-To-Protocol (ATP) cohort for efficacy included subjects with efficacy data available, who received 3 doses of vaccine, who were HPV DNA- for the corresponding type at enrollment and at the time of administration of the 3rd dose (Month 6) and who did not have a biopsy or treatment during the vaccination phase (prior to the Month 6).'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Unsolicited Adverse Events (AEs).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3727', 'groupId': 'OG000'}, {'value': '3739', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'Havrix Group', 'description': 'Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '1638', 'groupId': 'OG000'}, {'value': '1536', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 30 days (Days 0-29) after vaccination', 'description': 'An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.'}, {'id': 'FG001', 'title': 'Havrix Group', 'description': 'Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3727'}, {'groupId': 'FG001', 'numSubjects': '3739'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3453'}, {'groupId': 'FG001', 'numSubjects': '3481'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '274'}, {'groupId': 'FG001', 'numSubjects': '258'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '243'}, {'groupId': 'FG001', 'numSubjects': '232'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}], 'preAssignmentDetails': 'Solicited symptoms were collected for 3730 and 3740 subjects instead of the 3727 and 3739 subjects who were randomized in the study in the Cervarix and the Havrix groups, respectively. These 4 subjects received both vaccines and were included in the denominator of both arm based on the actual vaccine type administered.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3727', 'groupId': 'BG000'}, {'value': '3739', 'groupId': 'BG001'}, {'value': '7466', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.'}, {'id': 'BG001', 'title': 'Havrix Group', 'description': 'Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Years', 'categories': [{'measurements': [{'value': '21.1', 'spread': '2.3', 'groupId': 'BG000'}, {'value': '21.1', 'spread': '2.3', 'groupId': 'BG001'}, {'value': '21.1', 'spread': '2.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3727', 'groupId': 'BG000'}, {'value': '3739', 'groupId': 'BG001'}, {'value': '7466', '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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7466}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2010-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-12', 'studyFirstSubmitDate': '2005-08-08', 'resultsFirstSubmitDate': '2011-12-15', 'studyFirstSubmitQcDate': '2005-08-08', 'lastUpdatePostDateStruct': {'date': '2019-03-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-04-05', 'studyFirstPostDateStruct': {'date': '2005-08-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-05-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Cases Associated With HPV16 and/or HPV18 Infection Detected in the Preceding Cervical Cytology Specimen.', 'timeFrame': 'From Month 6 up to Month 48', 'description': 'CIN2+ was defined as CIN grade 2 (CIN2), CIN grade 3 (CIN3), adenocarcinoma in situ (AIS) or invasive cervical cancer. Preceding cervical cytology means the last cervical cytology specimen collected before the histopathology specimen was obtained. Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) by polymerase chain reaction (PCR) at Month 0 and Month 6 for the corresponding HPV-type.'}], 'secondaryOutcomes': [{'measure': 'Number of Cervical Infection With HPV16 or HPV18.', 'timeFrame': 'From Month 6 up to Month 48', 'description': 'Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type'}, {'measure': 'Number of Histopathologically Confirmed CIN2+ Cases Associated With Infection by Any Oncogenic HPV Type', 'timeFrame': 'From Month 6 up to Month 48', 'description': 'Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68 detected by polymerase chain reaction (PRC) in the preceding cervical cytology specimen. Note: The assay did not distinguish between HPV types 68 and 73. CIN2+ was defined as CIN grade 2 (CIN2), CIN grade 3 (CIN3), adenocarcinoma in situ (AIS) or invasive cervical cancer Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type'}, {'measure': 'Number of Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 Cases', 'timeFrame': 'From Month 6 up to Month 48', 'description': 'Persistent incident HPV-16 and /or HPV-18 cervical infection had to fulfil the following criteria: first detection after the 6-month visit, 2 same type HPV positive (by PCR) test results 10+ months apart, and no intervening HPV negative tests for the corresponding type. Persistent HPV16 or HPV18 cervical infection = detection of the same HPV type by polymerase chain reaction (PCR) in cervical samples from all consecutive evaluations over approximately 12 months. Subjects were HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type.'}, {'measure': 'Geometric Mean Titers (GMTs) for HPV-16 Antibody in the Immunogenicity Subcohort.', 'timeFrame': 'Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48', 'description': 'Titers were assessed for the 600 subjects enrolled into the immunogenicity subcohort by Enzyme linked immunosorbent assay (ELISA) and expressed as geometric mean titers (GMTs). Seronegative subjects = antibody concentration below 8 ELISA Units per millilitre (EL.U/mL) prior to vaccination. Seropositive subjects=antibody concentration equal to or above 8 EL.U/mL prior to vaccination. Immunogenicity subcohort = subset of 600 subjects from the 2 groups of the ATP cohort: subjects attended 1 extra clinic visit approximately 1 month (30 to 60 days) after the last dose was administered (Month 7)'}, {'measure': 'Geometric Mean Titers (GMTs) for HPV-18 Antibody in the Immunogenicity Subcohort', 'timeFrame': 'Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48', 'description': 'Titers were assessed for the 600 subjects enrolled into the immunogenicity subcohortby Enzyme linked immunosorbent assay (ELISA) and expressed as geometric mean titers (GMTs). Seronegative (Sero-) subjects=antibody concentration below 7 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects=antibody concentration equal to or above 7 EL.U/mL prior to vaccination. Immunogenicity subcohort=subset of 600 subjects from the 2 groups of the ATP cohort: subjects attended 1 extra clinic visit approximately 1 month (30 to 60 days) after the last dose was administered (Month 7).'}, {'measure': 'HPV-16 Geometric Mean Titers (GMTs) (V5 Monoclonal Antibody Inhibition Test)', 'timeFrame': 'Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48', 'description': 'Titers were assessed for the 600 subjects enrolled into the immunogenicity subcohort by Inhibition Enzyme Immunoassay (EIA) and expressed as geometric mean antibody titers (GMTs). Seronegative (Sero-) subjects=antibody concentration below 41 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects=antibody concentration equal to or above 41 EL.U/mL prior to vaccination. Immunogenicity subcohort=subset of 600 subjects from the 2 groups of the ATP cohort: subjects attended 1 extra clinic visit approximately 1 month (30 to 60 days) after the last dose was administered (Month 7).'}, {'measure': 'HPV-18 Geometric Mean Titers (GMTs) (J4 Monoclonal Antibody Inhibition Test)', 'timeFrame': 'Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48', 'description': 'Titers were assessed for the 600 subjects enrolled into the immunogenicity subcohort by Inhibition Enzyme Immunoassay (EIA) and expressed as geometric mean antibody titers (GMTs). Seronegative (Sero-) subjects=antibody concentration below 110 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects=antibody concentration equal to or above 110 EL.U/mL prior to vaccination. Immunogenicity subcohort=subset of 600 subjects from the 2 groups of the ATP cohort: subjects attended 1 extra clinic visit approximately 1 month (30 to 60 days) after the last dose was administered (Month 7).'}, {'measure': 'Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.', 'timeFrame': 'Within 60 minutes after vaccination', 'description': 'Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities as assessed by inability to attend work or school and which necessitated the administration of corrective therapy. Grade 3 redness and swelling was defined as redness/swelling above 50 millimeter (mm).'}, {'measure': 'Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.', 'timeFrame': 'Within 60 minutes after vaccination', 'description': 'Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (Fever = oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal everyday activities as assessed by inability to attend work or school and which necessitated the administration of corrective therapy.Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = oral temperature \\> 39.0°C.'}, {'measure': 'Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms on a 10% Random Subset of Participants.', 'timeFrame': 'From Day 3 to Day 6 after vaccination', 'description': 'Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities as assessed by inability to attend work or school and which necessitated the administration of corrective therapy. Grade 3 redness and swelling was defined as redness/swelling above 50 millimeter (mm).'}, {'measure': 'Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms on a 10% Random Subset of Participants.', 'timeFrame': 'From Day 3 to Day 6 after vaccination', 'description': 'Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (Fever = oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal everyday activities as assessed by inability to attend work or school and which necessitated the administration of corrective therapy.Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = oral temperature \\> 39.0°C.'}, {'measure': 'Number of Subjects Reporting Serious Adverse Events (SAEs).', 'timeFrame': 'During the entire study period (From Month 0 up to Month 48).', 'description': 'SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.'}, {'measure': 'Number of Subjects Reporting Unsolicited Adverse Events (AEs).', 'timeFrame': 'During the entire study period (From Month 0 up to Month 48).', 'description': 'An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.'}, {'measure': 'Number of Subjects With All Possible Pregnancy Outcomes', 'timeFrame': 'During the entire study period (From Month 0 up to Month 48).', 'description': 'The range of possible pregnancy outcomes was: Pregnancy loss, Pregnancy resolved alive, and Unresolved pregnancy.'}, {'measure': 'Number of Cervical Infection With HPV16 or HPV18.', 'timeFrame': 'During the first year of follow-up period', 'description': 'Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type'}, {'measure': 'Number of Cervical Infection With HPV16 or HPV18.', 'timeFrame': 'During the second year of follow-up period', 'description': 'Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type'}, {'measure': 'Number of Cervical Infection With HPV16 or HPV18.', 'timeFrame': 'During the third year of follow-up period', 'description': 'Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type'}, {'measure': 'Number of Cervical Infection With HPV16 or HPV18.', 'timeFrame': 'From the fourth year follow-up period', 'description': 'Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type'}, {'measure': 'Number of Subjects Reporting Unsolicited Adverse Events (AEs).', 'timeFrame': 'within 30 days (Days 0-29) after vaccination', 'description': 'An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.'}]}, 'conditionsModule': {'keywords': ['cervical intraepithelial neoplasia grade 2', 'cervical cancer', 'cervical intraepithelial neoplasia grade 3'], 'conditions': ['Cervical Cancer', 'Precancerous Condition']}, 'referencesModule': {'references': [{'pmid': '21908768', 'type': 'BACKGROUND', 'citation': 'Kreimer AR, Rodriguez AC, Hildesheim A, Herrero R, Porras C, Schiffman M, Gonzalez P, Solomon D, Jimenez S, Schiller JT, Lowy DR, Quint W, Sherman ME, Schussler J, Wacholder S; CVT Vaccine Group. 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Impact of human papillomavirus (HPV) 16 and 18 vaccination on prevalent infections and rates of cervical lesions after excisional treatment. Am J Obstet Gynecol. 2016 Aug;215(2):212.e1-212.e15. doi: 10.1016/j.ajog.2016.02.021. Epub 2016 Feb 16.'}, {'pmid': '26467666', 'type': 'DERIVED', 'citation': 'Beachler DC, Kreimer AR, Schiffman M, Herrero R, Wacholder S, Rodriguez AC, Lowy DR, Porras C, Schiller JT, Quint W, Jimenez S, Safaeian M, Struijk L, Schussler J, Hildesheim A, Gonzalez P; Costa Rica HPV Vaccine Trial (CVT) Group. Multisite HPV16/18 Vaccine Efficacy Against Cervical, Anal, and Oral HPV Infection. J Natl Cancer Inst. 2015 Oct 14;108(1):djv302. doi: 10.1093/jnci/djv302. Print 2016 Jan.'}, {'pmid': '26346155', 'type': 'DERIVED', 'citation': 'Panagiotou OA, Befano BL, Gonzalez P, Rodriguez AC, Herrero R, Schiller JT, Kreimer AR, Schiffman M, Hildesheim A, Wilcox AJ, Wacholder S; Costa Rica HPV Vaccine Trial (CVT) Group (see end of manuscript for full list of investigators). Effect of bivalent human papillomavirus vaccination on pregnancy outcomes: long term observational follow-up in the Costa Rica HPV Vaccine Trial. BMJ. 2015 Sep 7;351:h4358. doi: 10.1136/bmj.h4358.'}, {'pmid': '26071347', 'type': 'DERIVED', 'citation': 'Kreimer AR, Struyf F, Del Rosario-Raymundo MR, Hildesheim A, Skinner SR, Wacholder S, Garland SM, Herrero R, David MP, Wheeler CM; Costa Rica Vaccine Trial Study Group Authors; Gonzalez P, Jimenez S, Lowy DR, Pinto LA, Porras C, Rodriguez AC, Safaeian M, Schiffman M, Schiller JT, Schussler J, Sherman ME; PATRICIA Study Group Authors; Bosch FX, Castellsague X, Chatterjee A, Chow SN, Descamps D, Diaz-Mitoma F, Dubin G, Germar MJ, Harper DM, Lewis DJ, Limson G, Naud P, Peters K, Poppe WA, Ramjattan B, Romanowski B, Salmeron J, Schwarz TF, Teixeira JC, Tjalma WA; HPV PATRICIA Principal Investigators/Co-Principal Investigator Collaborators; GSK Vaccines Clinical Study Support Group. Efficacy of fewer than three doses of an HPV-16/18 AS04-adjuvanted vaccine: combined analysis of data from the Costa Rica Vaccine and PATRICIA Trials. Lancet Oncol. 2015 Jul;16(7):775-86. doi: 10.1016/S1470-2045(15)00047-9. Epub 2015 Jun 9.'}, {'pmid': '25796338', 'type': 'DERIVED', 'citation': 'Gonzalez P, Hildesheim A, Herrero R, Katki H, Wacholder S, Porras C, Safaeian M, Jimenez S, Darragh TM, Cortes B, Befano B, Schiffman M, Carvajal L, Palefsky J, Schiller J, Ocampo R, Schussler J, Lowy D, Guillen D, Stoler MH, Quint W, Morales J, Avila C, Rodriguez AC, Kreimer AR; Costa Rica HPV Vaccine Trial (CVT) Group. Rationale and design of a long term follow-up study of women who did and did not receive HPV 16/18 vaccination in Guanacaste, Costa Rica. Vaccine. 2015 Apr 27;33(18):2141-51. doi: 10.1016/j.vaccine.2015.03.015. Epub 2015 Mar 18.'}, {'pmid': '25139208', 'type': 'DERIVED', 'citation': 'Lang Kuhs KA, Porras C, Schiller JT, Rodriguez AC, Schiffman M, Gonzalez P, Wacholder S, Ghosh A, Li Y, Lowy DR, Kreimer AR, Poncelet S, Schussler J, Quint W, van Doorn LJ, Sherman ME, Sidawy M, Herrero R, Hildesheim A, Safaeian M; Costa Rica Vaccine Trial Group. Effect of different human papillomavirus serological and DNA criteria on vaccine efficacy estimates. Am J Epidemiol. 2014 Sep 15;180(6):599-607. doi: 10.1093/aje/kwu168. Epub 2014 Aug 19.'}, {'pmid': '25018097', 'type': 'DERIVED', 'citation': 'Hildesheim A, Wacholder S, Catteau G, Struyf F, Dubin G, Herrero R; CVT Group. Efficacy of the HPV-16/18 vaccine: final according to protocol results from the blinded phase of the randomized Costa Rica HPV-16/18 vaccine trial. Vaccine. 2014 Sep 3;32(39):5087-97. doi: 10.1016/j.vaccine.2014.06.038. Epub 2014 Jul 10.'}, {'pmid': '24958910', 'type': 'DERIVED', 'citation': 'Lang Kuhs KA, Gonzalez P, Rodriguez AC, van Doorn LJ, Schiffman M, Struijk L, Chen S, Quint W, Lowy DR, Porras C, DelVecchio C, Jimenez S, Safaeian M, Schiller JT, Wacholder S, Herrero R, Hildesheim A, Kreimer AR; Costa Rica Vaccine Trial Group. Reduced prevalence of vulvar HPV16/18 infection among women who received the HPV16/18 bivalent vaccine: a nested analysis within the Costa Rica Vaccine Trial. J Infect Dis. 2014 Dec 15;210(12):1890-9. doi: 10.1093/infdis/jiu357. Epub 2014 Jun 23.'}, {'pmid': '24014882', 'type': 'DERIVED', 'citation': 'Lang Kuhs KA, Gonzalez P, Struijk L, Castro F, Hildesheim A, van Doorn LJ, Rodriguez AC, Schiffman M, Quint W, Lowy DR, Porras C, Delvecchio C, Katki HA, Jimenez S, Safaeian M, Schiller J, Solomon D, Wacholder S, Herrero R, Kreimer AR; Costa Rica Vaccine Trial Group. Prevalence of and risk factors for oral human papillomavirus among young women in Costa Rica. J Infect Dis. 2013 Nov 15;208(10):1643-52. doi: 10.1093/infdis/jit369. Epub 2013 Sep 6.'}, {'pmid': '23873171', 'type': 'DERIVED', 'citation': 'Herrero R, Quint W, Hildesheim A, Gonzalez P, Struijk L, Katki HA, Porras C, Schiffman M, Rodriguez AC, Solomon D, Jimenez S, Schiller JT, Lowy DR, van Doorn LJ, Wacholder S, Kreimer AR; CVT Vaccine Group. Reduced prevalence of oral human papillomavirus (HPV) 4 years after bivalent HPV vaccination in a randomized clinical trial in Costa Rica. PLoS One. 2013 Jul 17;8(7):e68329. doi: 10.1371/journal.pone.0068329. Print 2013.'}, {'pmid': '23834901', 'type': 'DERIVED', 'citation': 'Clarke M, Schiffman M, Wacholder S, Rodriguez AC, Hildesheim A, Quint W; Costa Rican Vaccine Trial Group. A prospective study of absolute risk and determinants of human papillomavirus incidence among young women in Costa Rica. BMC Infect Dis. 2013 Jul 8;13:308. doi: 10.1186/1471-2334-13-308.'}, {'pmid': '22850119', 'type': 'DERIVED', 'citation': 'Castro FA, Quint W, Gonzalez P, Katki HA, Herrero R, van Doorn LJ, Schiffman M, Struijk L, Rodriguez AC, DelVecchio C, Lowy DR, Porras C, Jimenez S, Schiller J, Solomon D, Wacholder S, Hildesheim A, Kreimer AR; Costa Rica Vaccine Trial Group. Prevalence of and risk factors for anal human papillomavirus infection among young healthy women in Costa Rica. J Infect Dis. 2012 Oct 1;206(7):1103-10. doi: 10.1093/infdis/jis458. Epub 2012 Jul 30.'}, {'pmid': '21865087', 'type': 'DERIVED', 'citation': 'Kreimer AR, Gonzalez P, Katki HA, Porras C, Schiffman M, Rodriguez AC, Solomon D, Jimenez S, Schiller JT, Lowy DR, van Doorn LJ, Struijk L, Quint W, Chen S, Wacholder S, Hildesheim A, Herrero R; CVT Vaccine Group. Efficacy of a bivalent HPV 16/18 vaccine against anal HPV 16/18 infection among young women: a nested analysis within the Costa Rica Vaccine Trial. Lancet Oncol. 2011 Sep;12(9):862-70. doi: 10.1016/S1470-2045(11)70213-3. Epub 2011 Aug 22.'}, {'pmid': '20197322', 'type': 'DERIVED', 'citation': 'Wacholder S, Chen BE, Wilcox A, Macones G, Gonzalez P, Befano B, Hildesheim A, Rodriguez AC, Solomon D, Herrero R, Schiffman M; CVT group. Risk of miscarriage with bivalent vaccine against human papillomavirus (HPV) types 16 and 18: pooled analysis of two randomised controlled trials. BMJ. 2010 Mar 2;340:c712. doi: 10.1136/bmj.c712.'}, {'pmid': '18948732', 'type': 'DERIVED', 'citation': 'Dessy FJ, Giannini SL, Bougelet CA, Kemp TJ, David MP, Poncelet SM, Pinto LA, Wettendorff MA. Correlation between direct ELISA, single epitope-based inhibition ELISA and pseudovirion-based neutralization assay for measuring anti-HPV-16 and anti-HPV-18 antibody response after vaccination with the AS04-adjuvanted HPV-16/18 cervical cancer vaccine. Hum Vaccin. 2008 Nov-Dec;4(6):425-34. doi: 10.4161/hv.4.6.6912. Epub 2008 Nov 11.'}, {'pmid': '17699008', 'type': 'DERIVED', 'citation': 'Hildesheim A, Herrero R, Wacholder S, Rodriguez AC, Solomon D, Bratti MC, Schiller JT, Gonzalez P, Dubin G, Porras C, Jimenez SE, Lowy DR; Costa Rican HPV Vaccine Trial Group. Effect of human papillomavirus 16/18 L1 viruslike particle vaccine among young women with preexisting infection: a randomized trial. JAMA. 2007 Aug 15;298(7):743-53. doi: 10.1001/jama.298.7.743.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Chemoprevention is the use of certain drugs to keep cancer form forming, growing, or coming back. Vaccines may help the body build an effective immune response against human papillomavirus and may be effective in preventing cervical intraepithelial neoplasia or cervical cancer. It is not yet known whether human papillomavirus vaccine is more effective than hepatitis A vaccine in preventing cervical intraepithelial neoplasia or cervical cancer.\n\nPURPOSE: This randomized phase III trial is studying human papillomavirus vaccine to see how well it works compared to hepatitis A vaccine in preventing cervical intraepithelial neoplasia or cervical cancer in younger healthy participants.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n•Demonstrate the efficacy of the candidate vaccine, human papillomavirus 16/18 (HPV 16/18) L1 virus-like particle (VLP)/AS04 vaccine compared with control in preventing grade 2 or 3 cervical intraepithelial neoplasia, adenocarcinoma in situ of the cervix, or invasive cervical cancer (CIN2+) associated with HPV 16 or HPV 18 cervical infection in younger healthy participants who are negative for HPV DNA by polymerase chain reaction (PCR) for the corresponding HPV type at months 0 and 6.\n\nSecondary\n\n* Determine the duration of protection against HPV 16 or HPV 18 cervical infection in participants treated with the HPV 16/18 L1 VLP/AS04 vaccine.\n* Determine the safety of this vaccine in these participants, regardless of their initial HPV 16/18 DNA status.\n* Evaluate the efficacy of the candidate vaccine, HPV 16/18 L1 VLP/AS04 vaccine compared with control in preventing CIN2+ associated with any oncogenic HPV type cervical infection in participants who are negative for HPV DNA by PCR for the corresponding HPV type at months 0 and 6.\n* Compare the efficacy of the candidate vaccine with control in preventing CIN2+ associated with HPV 16 or HPV 18 cervical infection, detected within the lesional component of the cervical tissue specimen by PCR, in participants who are negative for HPV DNA by PCR for the corresponding HPV type at months 0 and 6 and by enzyme-linked immunosorbent assay (ELISA) at month 0.\n* Compare the efficacy of the candidate vaccine with control in preventing persistent HPV 16 or HPV 18 cervical infection in these participants.\n* Determine the immunogenicity of HPV 16/18 L1 VLP/AS04 vaccine by ELISA and V5/J4 monoclonal antibody inhibition enzyme immunoassay in the first 600 participants randomized to receive HPV 16/18 L1 VLP/AS04 vaccine.\n\nOUTLINE: This is a randomized, controlled, double-blind, parallel-group study. Participants are randomized to 1 of 2 treatment arms.\n\n* Arm I: Participants receive human papillomavirus 16/18 L1 virus-like particle/AS04 vaccine intramuscularly (IM) once in months 0, 1, and 6.\n* Arm II: Participants receive hepatitis A vaccine (Havrix®) IM once in months 0, 1, and 6.\n\nAfter completion of study treatment, participants are followed at 6 months and then at least annually for 3 years.\n\nPROJECTED ACCRUAL: Approximately 7,500 participants will be accrued for this study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n•Healthy participants\n\n* Deemed to be in good general health by history and physical examination\n\n •Resident of Guanacaste Province of Costa Rica and surrounding areas\n* Must remain a resident for ≥ 6 months after the first study vaccination\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 to 25\n\nPerformance status\n\n•Not specified\n\nLife expectancy\n\n•Not specified\n\nHematopoietic\n\n•Not specified\n\nHepatic\n\n* No history of chronic hepatitis requiring treatment\n* No acute or chronic clinically significant hepatic function abnormality by physical examination or laboratory findings\n* No known history of hepatitis A infection\n\nRenal\n\n* No history of kidney disease requiring treatment\n* No acute or chronic clinically significant kidney function abnormality by physical examination or laboratory findings\n\nCardiovascular\n\n* No acute or chronic clinically significant cardiovascular function abnormality by physical examination or laboratory findings Pulmonary\n* No acute or chronic clinically significant pulmonary function abnormality by physical examination or laboratory findings Immunology\n* No history of allergic disease\n* No history of autoimmune disorder requiring treatment\n* No history of allergic reaction (e.g., difficulty breathing) to any vaccine\n* No suspected allergy or reaction likely to be exacerbated by a component of the study vaccines (e.g., 2-phenoxyethanol or neomycin)\n* No hypersensitivity to latex\n* No diagnosis or suspicion of any immunodeficient condition by medical history or physical examination Other\n* Not pregnant or nursing\n\n ◦No delivery within the past 3 months\n* Negative pregnancy test\n* Fertile patients must use effective contraception for 30 days before, during, and for 60 days after completion of study treatment\n* Able to speak or understand Spanish\n* Mentally competent\n* Able to undergo pelvic exam (i.e., no heavy bleeding \\[menstruation or otherwise\\] or heavy vaginal discharge)\n* No history of cancer requiring treatment\n* No history of diabetes requiring treatment\n* No history of other chronic conditions requiring treatment\n* No acute or chronic clinically significant neurologic function abnormality by physical examination or laboratory findings\n* No other acute disease\n* No fever ≥ 37.5º C\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* More than 6 months since prior chronic administration (i.e., \\> 14 days) of immune-modulating drugs\n* More than 90 days since prior immunoglobulins\n* More than 30 days since prior and no other concurrent investigational or non-registered vaccines\n* More than 30 days since prior registered vaccines\n* More than 8 days since prior routine meningococcal, hepatitis B, influenza, or diphtheria/tetanus vaccine\n* No prior vaccination against hepatitis A\n* No prior vaccination against human papillomavirus\n* No prior monophosphoryl lipid A or AS04 adjuvant\n\nChemotherapy\n\n•Not specified\n\nEndocrine therapy\n\n* More than 6 months since prior chronic administration (i.e., \\> 14 days) of corticosteroids (e.g., ≥ 0.5 mg/kg/day of prednisone or equivalent)\n* Concurrent inhaled or topical steroids allowed\n\nRadiotherapy\n\n•Not specified\n\nSurgery\n\n•No prior hysterectomy\n\nOther\n\n* More than 6 months since prior chronic administration (i.e., \\> 14 days) of immunosuppressants\n* More than 30 days since prior and no other concurrent investigational or non-registered drugs'}, 'identificationModule': {'nctId': 'NCT00128661', 'briefTitle': 'Vaccine To Prevent Cervical Intraepithelial Neoplasia or Cervical Cancer in Younger Healthy Participants', 'nctIdAliases': ['NCT00344357'], 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Double-Blind, Controlled, Randomized, Phase III Study of the Efficacy of an HPV16/18 VLP Vaccine in the Prevention of Advanced Cervical Intraepithelial Neoplasia (CIN2, CIN3, Adenocarcinoma In Situ [AIS] and Invasive Cervical Cancer) Associated With HPV 16 or HPV 18 Cervical Infection in Healthy Young Adult Women in Costa Rica.', 'orgStudyIdInfo': {'id': 'CDR0000441189'}, 'secondaryIdInfos': [{'id': 'NCI-04-C-N191'}, {'id': 'NCI-590299/009'}, {'id': 'GSK-590299/009', 'type': 'OTHER', 'domain': 'GSK Bio'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cervarix Group', 'description': 'Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.', 'interventionNames': ['Biological: human papillomavirus 16/18 L1 virus-like particle/AS04 vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Havrix Group', 'description': 'Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.', 'interventionNames': ['Biological: hepatitis A inactivated virus vaccine']}], 'interventions': [{'name': 'human papillomavirus 16/18 L1 virus-like particle/AS04 vaccine', 'type': 'BIOLOGICAL', 'description': 'Three doses of Cervarix vaccine administered on a 0, 1, 6-month schedule', 'armGroupLabels': ['Cervarix Group']}, {'name': 'hepatitis A inactivated virus vaccine', 'type': 'BIOLOGICAL', 'description': 'Three doses of Havrix vaccine administered on a 0, 1, 6-month schedule', 'armGroupLabels': ['Havrix Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Liberia', 'country': 'Costa Rica', 'facility': 'Proyecto Epidemiologico Guanacaste', 'geoPoint': {'lat': 10.63517, 'lon': -85.43779}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}