| ID | Type | Description | Link |
|---|---|---|---|
| NCI-04-C-N191 | |||
| NCI-590299/009 | |||
| GSK-590299/009 | Other Identifier | GSK Bio |
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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.
PURPOSE: 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.
OBJECTIVES:
Primary
•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.
Secondary
OUTLINE: This is a randomized, controlled, double-blind, parallel-group study. Participants are randomized to 1 of 2 treatment arms.
After completion of study treatment, participants are followed at 6 months and then at least annually for 3 years.
PROJECTED ACCRUAL: Approximately 7,500 participants will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cervarix Group | Experimental | 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. |
|
| Havrix Group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| human papillomavirus 16/18 L1 virus-like particle/AS04 vaccine | Biological | Three doses of Cervarix vaccine administered on a 0, 1, 6-month schedule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Cases Associated With HPV16 and/or HPV18 Infection Detected in the Preceding Cervical Cytology Specimen. | 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. | From Month 6 up to Month 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Cervical Infection With HPV16 or HPV18. | Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type | From Month 6 up to Month 48 |
| Number of Histopathologically Confirmed CIN2+ Cases Associated With Infection by Any Oncogenic HPV Type |
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DISEASE CHARACTERISTICS:
•Healthy participants
Deemed to be in good general health by history and physical examination
•Resident of Guanacaste Province of Costa Rica and surrounding areas
Must remain a resident for ≥ 6 months after the first study vaccination
PATIENT CHARACTERISTICS:
Age
Performance status
•Not specified
Life expectancy
•Not specified
Hematopoietic
•Not specified
Hepatic
Renal
Cardiovascular
No acute or chronic clinically significant cardiovascular function abnormality by physical examination or laboratory findings Pulmonary
No acute or chronic clinically significant pulmonary function abnormality by physical examination or laboratory findings Immunology
No history of allergic disease
No history of autoimmune disorder requiring treatment
No history of allergic reaction (e.g., difficulty breathing) to any vaccine
No suspected allergy or reaction likely to be exacerbated by a component of the study vaccines (e.g., 2-phenoxyethanol or neomycin)
No hypersensitivity to latex
No diagnosis or suspicion of any immunodeficient condition by medical history or physical examination Other
Not pregnant or nursing
â—¦No delivery within the past 3 months
Negative pregnancy test
Fertile patients must use effective contraception for 30 days before, during, and for 60 days after completion of study treatment
Able to speak or understand Spanish
Mentally competent
Able to undergo pelvic exam (i.e., no heavy bleeding [menstruation or otherwise] or heavy vaginal discharge)
No history of cancer requiring treatment
No history of diabetes requiring treatment
No history of other chronic conditions requiring treatment
No acute or chronic clinically significant neurologic function abnormality by physical examination or laboratory findings
No other acute disease
No fever ≥ 37.5º C
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
•Not specified
Endocrine therapy
Radiotherapy
•Not specified
Surgery
•No prior hysterectomy
Other
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Proyecto Epidemiologico Guanacaste | Liberia | Costa Rica |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21908768 | Background | 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. Proof-of-principle evaluation of the efficacy of fewer than three doses of a bivalent HPV16/18 vaccine. J Natl Cancer Inst. 2011 Oct 5;103(19):1444-51. doi: 10.1093/jnci/djr319. Epub 2011 Sep 9. | |
| 21241731 |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cervarix Group | 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. |
| FG001 | Havrix Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| hepatitis A inactivated virus vaccine | Biological | Three doses of Havrix vaccine administered on a 0, 1, 6-month schedule |
|
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 |
| From Month 6 up to Month 48 |
| Number of Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 Cases | 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. | From Month 6 up to Month 48 |
| Geometric Mean Titers (GMTs) for HPV-16 Antibody in the Immunogenicity Subcohort. | 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) | Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48 |
| Geometric Mean Titers (GMTs) for HPV-18 Antibody in the Immunogenicity Subcohort | 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). | Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48 |
| HPV-16 Geometric Mean Titers (GMTs) (V5 Monoclonal Antibody Inhibition Test) | 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). | Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48 |
| HPV-18 Geometric Mean Titers (GMTs) (J4 Monoclonal Antibody Inhibition Test) | 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). | Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48 |
| Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | 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). | Within 60 minutes after vaccination |
| Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | 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. | Within 60 minutes after vaccination |
| Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms on a 10% Random Subset of Participants. | 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). | From Day 3 to Day 6 after vaccination |
| Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms on a 10% Random Subset of Participants. | 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. | From Day 3 to Day 6 after vaccination |
| Number of Subjects Reporting Serious Adverse Events (SAEs). | 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. | During the entire study period (From Month 0 up to Month 48). |
| Number of Subjects Reporting Unsolicited Adverse Events (AEs). | 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. | During the entire study period (From Month 0 up to Month 48). |
| Number of Subjects With All Possible Pregnancy Outcomes | The range of possible pregnancy outcomes was: Pregnancy loss, Pregnancy resolved alive, and Unresolved pregnancy. | During the entire study period (From Month 0 up to Month 48). |
| Number of Cervical Infection With HPV16 or HPV18. | Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type | During the first year of follow-up period |
| Number of Cervical Infection With HPV16 or HPV18. | Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type | During the second year of follow-up period |
| Number of Cervical Infection With HPV16 or HPV18. | Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type | During the third year of follow-up period |
| Number of Cervical Infection With HPV16 or HPV18. | Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type | From the fourth year follow-up period |
| Number of Subjects Reporting Unsolicited Adverse Events (AEs). | 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. | within 30 days (Days 0-29) after vaccination |
| Background |
| Kemp TJ, Hildesheim A, Safaeian M, Dauner JG, Pan Y, Porras C, Schiller JT, Lowy DR, Herrero R, Pinto LA. HPV16/18 L1 VLP vaccine induces cross-neutralizing antibodies that may mediate cross-protection. Vaccine. 2011 Mar 3;29(11):2011-4. doi: 10.1016/j.vaccine.2011.01.001. Epub 2011 Jan 15. |
| 40796225 | Derived | Sierra MS, Coto C, Porras C, Herrero R, Ugalde D, Sauer AN, Mora D, Montes CP, Schussler J, Hoffman AC, Hicks B, Ruggieri D, Cortes B, Hildesheim A, Kreimer AR, Wentzensen N, Dagnall C, Liu D. Validation of TypeSeq2, a Next-Generation-Based Sequencing Assay for the Detection of 46 Human Papillomavirus Genotypes, at the US National Cancer Institute and Costa Rica Laboratories. J Infect Dis. 2025 Dec 20;232(6):e906-e915. doi: 10.1093/infdis/jiaf369. |
| 39961279 | Derived | Sierra MS, Carvajal LJ, Dull P, Herrero R, Schussler J, Hildesheim A, Schiller JT, Ocampo R, Liu D, Kreimer AR, Rodriguez AC, Lowy DR, Porras C; Costa Rica HPV Vaccine Trial (CVT) Group. Human papillomavirus type 16 and 18 viral clearance and progression to precancer among women aged 18-25 years enrolled in the Costa Rica HPV prophylactic vaccine trial (CVT). Vaccine. 2025 Mar 19;50:126841. doi: 10.1016/j.vaccine.2025.126841. Epub 2025 Feb 16. |
| 37040086 | Derived | Befano B, Campos NG, Egemen D, Herrero R, Schiffman M, Porras C, Lowy DR, Rodriguez AC, Schiller JT, Ocampo R, Hildesheim A, Sampson JN, Das S, Kreimer AR, Cheung LC; Costa Rica HPV Vaccine Trial (CVT) Group. Estimating human papillomavirus vaccine efficacy from a single-arm trial: proof-of-principle in the Costa Rica Vaccine Trial. J Natl Cancer Inst. 2023 Jul 6;115(7):788-795. doi: 10.1093/jnci/djad064. |
| 35842229 | Derived | Sierra MS, Tsang SH, Porras C, Herrero R, Sampson JN, Cortes B, Schussler J, Wagner S, Carvajal L, Quint W, Kreimer AR, Hu S, Rodriguez AC, Romero B, Hildesheim A; Costa Rica HPV Vaccine Trial (CVT) Group. Analysis of cervical HPV infections among unvaccinated young adult women to inform vaccine strategies in this age group: the Costa Rica HPV Vaccine Trial. Sex Transm Infect. 2022 Jul 16;99(3):180-6. doi: 10.1136/sextrans-2022-055434. Online ahead of print. |
| 35709811 | Derived | Shing JZ, Hu S, Herrero R, Hildesheim A, Porras C, Sampson JN, Schussler J, Schiller JT, Lowy DR, Sierra MS, Carvajal L, Kreimer AR; Costa Rica HPV Vaccine Trial Group. Precancerous cervical lesions caused by non-vaccine-preventable HPV types after vaccination with the bivalent AS04-adjuvanted HPV vaccine: an analysis of the long-term follow-up study from the randomised Costa Rica HPV Vaccine Trial. Lancet Oncol. 2022 Jul;23(7):940-949. doi: 10.1016/S1470-2045(22)00291-1. Epub 2022 Jun 13. |
| 35017496 | Derived | Usyk M, Schlecht NF, Pickering S, Williams L, Sollecito CC, Gradissimo A, Porras C, Safaeian M, Pinto L, Herrero R, Strickler HD, Viswanathan S, Nucci-Sack A, Diaz A; Costa Rica HPV Vaccine Trial (CVT) Group; Burk RD. molBV reveals immune landscape of bacterial vaginosis and predicts human papillomavirus infection natural history. Nat Commun. 2022 Jan 11;13(1):233. doi: 10.1038/s41467-021-27628-3. |
| 32214382 | Derived | Usyk M, Zolnik CP, Castle PE, Porras C, Herrero R, Gradissimo A, Gonzalez P, Safaeian M, Schiffman M, Burk RD; Costa Rica HPV Vaccine Trial (CVT) Group. Cervicovaginal microbiome and natural history of HPV in a longitudinal study. PLoS Pathog. 2020 Mar 26;16(3):e1008376. doi: 10.1371/journal.ppat.1008376. eCollection 2020 Mar. |
| 29718393 | Derived | Safaeian M, Castellsague X, Hildesheim A, Wacholder S, Schiffman MH, Bozonnat MC, Baril L, Rosillon D; Costa Rica HPV Vaccine Trial and the PATRICIA study groups. Risk of HPV-16/18 Infections and Associated Cervical Abnormalities in Women Seropositive for Naturally Acquired Antibodies: Pooled Analysis Based on Control Arms of Two Large Clinical Trials. J Infect Dis. 2018 Jun 5;218(1):84-94. doi: 10.1093/infdis/jiy112. |
| 26892991 | Derived | Hildesheim A, Gonzalez P, Kreimer AR, Wacholder S, Schussler J, Rodriguez AC, Porras C, Schiffman M, Sidawy M, Schiller JT, Lowy DR, Herrero R; Costa Rica HPV Vaccine Trial (CVT) Group. 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. |
| 26467666 | Derived | 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. |
| 26346155 | Derived | 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. |
| 26071347 | Derived | 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. |
| 25796338 | Derived | 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. |
| 25139208 | Derived | 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. |
| 25018097 | Derived | 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. |
| 24958910 | Derived | 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. |
| 24014882 | Derived | 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. |
| 23873171 | Derived | 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. |
| 23834901 | Derived | 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. |
| 22850119 | Derived | 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. |
| 21865087 | Derived | 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. |
| 20197322 | Derived | 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. |
| 18948732 | Derived | 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. |
| 17699008 | Derived | 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. |
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.
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cervarix Group | 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. |
| BG001 | Havrix Group | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Cases Associated With HPV16 and/or HPV18 Infection Detected in the Preceding Cervical Cytology Specimen. | 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. | 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). | Posted | Number | Events | From Month 6 up to Month 48 |
|
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| Secondary | Number of Cervical Infection With HPV16 or HPV18. | Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type | 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). | Posted | Number | Events | From Month 6 up to Month 48 |
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| Secondary | Number of Histopathologically Confirmed CIN2+ Cases Associated With Infection by Any Oncogenic HPV Type | 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 | 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). | Posted | Number | Events | From Month 6 up to Month 48 |
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| Secondary | Number of Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 Cases | 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. | 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). | Posted | Number | Events | From Month 6 up to Month 48 |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Titers (GMTs) for HPV-16 Antibody in the Immunogenicity Subcohort. | 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) | 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. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48 |
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| Secondary | Geometric Mean Titers (GMTs) for HPV-18 Antibody in the Immunogenicity Subcohort | 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). | 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. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48 |
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| Secondary | HPV-16 Geometric Mean Titers (GMTs) (V5 Monoclonal Antibody Inhibition Test) | 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). | 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. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48 |
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| Secondary | HPV-18 Geometric Mean Titers (GMTs) (J4 Monoclonal Antibody Inhibition Test) | 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). | 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. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48 |
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| Secondary | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | 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). | The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented. | Posted | Number | Subjects | Within 60 minutes after vaccination |
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| Secondary | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | 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. | The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented. | Posted | Number | Subjects | Within 60 minutes after vaccination |
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| Secondary | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms on a 10% Random Subset of Participants. | 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). | The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented. | Posted | Number | Subjects | From Day 3 to Day 6 after vaccination |
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| Secondary | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms on a 10% Random Subset of Participants. | 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. | The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented. | Posted | Number | Subjects | From Day 3 to Day 6 after vaccination |
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| Secondary | Number of Subjects Reporting Serious Adverse Events (SAEs). | 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. | The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented. | Posted | Number | Subjects | During the entire study period (From Month 0 up to Month 48). |
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| Secondary | Number of Subjects Reporting Unsolicited Adverse Events (AEs). | 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. | The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented. | Posted | Number | Subjects | During the entire study period (From Month 0 up to Month 48). |
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| Secondary | Number of Subjects With All Possible Pregnancy Outcomes | The range of possible pregnancy outcomes was: Pregnancy loss, Pregnancy resolved alive, and Unresolved pregnancy. | The analysis was performed on the Total Vaccinated Cohort, on all pregnant subjects. | Posted | Number | subjects | During the entire study period (From Month 0 up to Month 48). |
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| Secondary | Number of Cervical Infection With HPV16 or HPV18. | Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type | 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). | Posted | Number | Events | During the first year of follow-up period |
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| Secondary | Number of Cervical Infection With HPV16 or HPV18. | Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type | 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). | Posted | Number | Events | During the second year of follow-up period |
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| Secondary | Number of Cervical Infection With HPV16 or HPV18. | Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type | 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). | Posted | Number | Events | During the third year of follow-up period |
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| Secondary | Number of Cervical Infection With HPV16 or HPV18. | Subjects were human papillomavirus (HPV) deoxyribonucleic acid (DNA) negative (DNA-) (by PCR) at Month 0 and Month 6 for the corresponding HPV-type | 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). | Posted | Number | Events | From the fourth year follow-up period |
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| Secondary | Number of Subjects Reporting Unsolicited Adverse Events (AEs). | 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. | The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented. | Posted | Number | Subjects | within 30 days (Days 0-29) after vaccination |
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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
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cervarix Group | 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. | 912 | 3,727 | 1,627 | 3,730 | ||
| EG001 | Havrix Group | 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. | 891 | 3,739 | 1,610 | 3,740 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abortion spontaneous incomplete | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| False labour | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Abortion spontaneous complete | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Abortion missed | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Foetal distress syndrome | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Caesarean section | Surgical and medical procedures | Non-systematic Assessment |
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| Uterine hypotonus | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Gestational hypertension | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| Dengue fever | Infections and infestations | Non-systematic Assessment |
| ||
| Abortion threatened | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Cephalo-pelvic disproportion | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Breech presentation | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Anaemia of pregnancy | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Cholecystitis | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Failed induction of labour | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Complication of pregnancy | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| Intentional self-injury | Psychiatric disorders | Non-systematic Assessment |
| ||
| Appendicitis | Infections and infestations | Non-systematic Assessment |
| ||
| Intra-uterine death | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Foetal growth restriction | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Cholelithiasis | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Premature rupture of membranes | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Obstructed labour | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Abnormal product of conception | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Postoperative wound infection | Infections and infestations | Non-systematic Assessment |
| ||
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Postpartum haemorrhage | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Postpartum sepsis | Infections and infestations | Non-systematic Assessment |
| ||
| Oligohydramnios | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Benign ovarian tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Gastrointestinal disorder | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Premature separation of placenta | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Hyperemesis gravidarum | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Multiple injuries | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Gestational diabetes | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypertension | Vascular disorders | Non-systematic Assessment |
| ||
| Ovarian cyst | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Pancreatitis acute | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Multiple pregnancy | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Placenta praevia haemorrhage | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Subcutaneous abscess | Infections and infestations | Non-systematic Assessment |
| ||
| Uterine haemorrhage | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Foetal disorder | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Depression | Psychiatric disorders | Non-systematic Assessment |
| ||
| Infectious peritonitis | Infections and infestations | Non-systematic Assessment |
| ||
| Large for dates baby | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Mental disorder | Psychiatric disorders | Non-systematic Assessment |
| ||
| Injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Menometrorrhagia | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Postoperative wound complication | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Premature delivery | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Vaginal haemorrhage | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Pelvic inflammatory disease | Infections and infestations | Non-systematic Assessment |
| ||
| Premature labour | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Pyrexia | General disorders | Non-systematic Assessment |
| ||
| Transverse presentation | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Abortion incomplete | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Cardiovascular disorder | Cardiac disorders | Non-systematic Assessment |
| ||
| Cellulitis | Infections and infestations | Non-systematic Assessment |
| ||
| Concussion | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Essential hypertension | Vascular disorders | Non-systematic Assessment |
| ||
| Irritable bowel syndrome | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Salpingitis | Infections and infestations | Non-systematic Assessment |
| ||
| Staphylococcal infection | Infections and infestations | Non-systematic Assessment |
| ||
| Umbilical cord abnormality | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Breast inflammation | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Bronchopneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Eclampsia | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Endometriosis | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Lower limb fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Open wound | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Pelvic pain | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Perineal pain | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Retained placenta or membranes | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Viral infection | Infections and infestations | Non-systematic Assessment |
| ||
| Abortion complicated | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Amniotic cavity infection | Infections and infestations | Non-systematic Assessment |
| ||
| Bartholin's abscess | Infections and infestations | Non-systematic Assessment |
| ||
| Bronchitis | Infections and infestations | Non-systematic Assessment |
| ||
| Calculus urinary | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Circulatory collapse | Vascular disorders | Non-systematic Assessment |
| ||
| Colitis ulcerative | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Foetal malpresentation | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Genital disorder female | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Humerus fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Hyperthyroidism | Endocrine disorders | Non-systematic Assessment |
| ||
| Liver disorder | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Lymphadenitis | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Menstruation irregular | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Migraine | Nervous system disorders | Non-systematic Assessment |
| ||
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Physical assault | Social circumstances | Non-systematic Assessment |
| ||
| Placenta praevia | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Sexually transmitted disease | Infections and infestations | Non-systematic Assessment |
| ||
| Toxicity to various agents | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Tubulointerstitial nephritis | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Anaphylactic shock | Immune system disorders | Non-systematic Assessment |
| ||
| Appendix disorder | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Bartholin's cyst | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Benign hydatidiform mole | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Blood disorder | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Cervix disorder | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Convulsion | Nervous system disorders | Non-systematic Assessment |
| ||
| Gastrointestinal inflammation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| HIV infection | Infections and infestations | Non-systematic Assessment |
| ||
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Multiple fractures | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Nephrolithiasis | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Nervous system disorder | Nervous system disorders | Non-systematic Assessment |
| ||
| Otitis externa | Infections and infestations | Non-systematic Assessment |
| ||
| Parametritis | Infections and infestations | Non-systematic Assessment |
| ||
| Phlebitis | Vascular disorders | Non-systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Polyhydramnios | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Post procedural complication | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Post-traumatic stress disorder | Psychiatric disorders | Non-systematic Assessment |
| ||
| Proteinuria | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Road traffic accident | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Status asthmaticus | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Tension headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Thermal burn | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Tooth abscess | Infections and infestations | Non-systematic Assessment |
| ||
| Traumatic delivery | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Ulna fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Umbilical cord prolapse | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Urticaria | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Uterine polyp | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Vaginal infection | Infections and infestations | Non-systematic Assessment |
| ||
| Varicose vein | Vascular disorders | Non-systematic Assessment |
| ||
| Venom poisoning | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Abdominal mass | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Abdominal pain lower | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Abdominal pain upper | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Abortion incomplete complicated | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Abortion spontaneous incomplete complicated | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Acute myocardial infarction | Cardiac disorders | Non-systematic Assessment |
| ||
| Acute psychosis | Psychiatric disorders | Non-systematic Assessment |
| ||
| Amenorrhoea | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Anaemia haemolytic autoimmune | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Anal abscess | Infections and infestations | Non-systematic Assessment |
| ||
| Autonomic nervous system imbalance | Nervous system disorders | Non-systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Bile duct stone | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Biliary cirrhosis | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Biliary tract disorder | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Breast abscess | Infections and infestations | Non-systematic Assessment |
| ||
| Breast disorder | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Breast enlargement | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Calculus ureteric | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Candida sepsis | Infections and infestations | Non-systematic Assessment |
| ||
| Cervical dysplasia | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Chemical poisoning | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Chronic sinusitis | Infections and infestations | Non-systematic Assessment |
| ||
| Colon neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Complicated migraine | Nervous system disorders | Non-systematic Assessment |
| ||
| Congenital flat feet | Congenital, familial and genetic disorders | Non-systematic Assessment |
| ||
| Congestive cardiomyopathy | Cardiac disorders | Non-systematic Assessment |
| ||
| Contusion | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Crohn's disease | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Diabetic ketoacidosis | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Drug dependence | Psychiatric disorders | Non-systematic Assessment |
| ||
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Embolism venous | Vascular disorders | Non-systematic Assessment |
| ||
| Emotional disorder | Psychiatric disorders | Non-systematic Assessment |
| ||
| Epilepsy | Nervous system disorders | Non-systematic Assessment |
| ||
| Eye complication associated with device | General disorders | Non-systematic Assessment |
| ||
| Eye degenerative disorder | Eye disorders | Non-systematic Assessment |
| ||
| Facial bones fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Femoral hernia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Femoral neck fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Foetal malposition | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Foot fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Foreign body | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Gait disturbance | General disorders | Non-systematic Assessment |
| ||
| Gastritis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Gastrointestinal haemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Genital herpes | Infections and infestations | Non-systematic Assessment |
| ||
| Genitourinary tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Granuloma skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Haematocolpos | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Haematosalpinx | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Haematuria | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Haemorrhagic anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Haemorrhagic disorder | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Hydrocephalus | Nervous system disorders | Non-systematic Assessment |
| ||
| Hypokalaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Ileus paralytic | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Intervertebral disc displacement | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Intestinal obstruction | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Intracranial hypotension | Nervous system disorders | Non-systematic Assessment |
| ||
| Intrapartum haemorrhage | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Jaw fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Malaria | Infections and infestations | Non-systematic Assessment |
| ||
| Mastitis postpartum | Infections and infestations | Non-systematic Assessment |
| ||
| Medical observation | Investigations | Non-systematic Assessment |
| ||
| Meningitis viral | Infections and infestations | Non-systematic Assessment |
| ||
| Multiple congenital abnormalities | Congenital, familial and genetic disorders | Non-systematic Assessment |
| ||
| Muscle injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Muscle strain | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Nasal sinus cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Neonatal respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Otitis media | Infections and infestations | Non-systematic Assessment |
| ||
| Ovarian torsion | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Ovulation pain | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Pancreatitis chronic | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Pelvic haematoma obstetric | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Peritoneal adhesions | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Peritoneal disorder | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Pilonidal cyst | Infections and infestations | Non-systematic Assessment |
| ||
| Placental disorder | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Placental neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pneumonia viral | Infections and infestations | Non-systematic Assessment |
| ||
| Polycystic ovaries | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Polymenorrhagia | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Post abortion haemorrhage | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Post procedural infection | Infections and infestations | Non-systematic Assessment |
| ||
| Postpartum disorder | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Previous caesarean section | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Prolonged labour | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Prolonged pregnancy | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Psychotic disorder | Psychiatric disorders | Non-systematic Assessment |
| ||
| Pyoderma | Infections and infestations | Non-systematic Assessment |
| ||
| Radius fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Retinal disorder | Eye disorders | Non-systematic Assessment |
| ||
| Rhesus incompatibility | Immune system disorders | Non-systematic Assessment |
| ||
| Sexual abuse | Social circumstances | Non-systematic Assessment |
| ||
| Skin disorder | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Skin infection | Infections and infestations | Non-systematic Assessment |
| ||
| Strabismus | Eye disorders | Non-systematic Assessment |
| ||
| Syphilis | Infections and infestations | Non-systematic Assessment |
| ||
| Tendon injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Tenosynovitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Therapeutic procedure | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Tibia fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Tooth ankylosis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Tooth development disorder | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Tooth malformation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Toxic skin eruption | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Twin pregnancy | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Ulcerative keratitis | Eye disorders | Non-systematic Assessment |
| ||
| Uterine inversion | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Varicella | Infections and infestations | Non-systematic Assessment |
| ||
| Varicophlebitis | Vascular disorders | Non-systematic Assessment |
| ||
| Vascular headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Vulval abscess | Infections and infestations | Non-systematic Assessment |
| ||
| Vulval neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | Systematic Assessment | Within 60 minutes after vaccination. |
| |
| Redness | General disorders | Systematic Assessment | Within 60 minutes after vaccination. |
| |
| Swelling | General disorders | Systematic Assessment | Within 60 minutes after vaccination. |
| |
| Fatigue | General disorders | Systematic Assessment | Within 60 minutes after vaccination. |
| |
| Myalgia | General disorders | Systematic Assessment | Within 60 minutes after vaccination. |
| |
| Gastrointestinal | General disorders | Systematic Assessment | Within 60 minutes after vaccination. |
| |
| Headache | General disorders | Systematic Assessment | Within 60 minutes after vaccination. |
| |
| Fever | General disorders | Systematic Assessment | Within 60 minutes after vaccination. |
| |
| Pain | General disorders | Systematic Assessment | From Day 3 to Day 6 post-vaccination, in a 10% random subset of participants. |
| |
| Swelling | General disorders | Systematic Assessment | From Day 3 to Day 6 post-vaccination, in a 10% random subset of participants. |
| |
| Fatigue | General disorders | Systematic Assessment | From Day 3 to Day 6 post-vaccination, in a 10% random subset of participants. |
| |
| Myalgia | General disorders | Systematic Assessment | From Day 3 to Day 6 post-vaccination, in a 10% random subset of participants. |
| |
| Arthralgia | General disorders | Systematic Assessment | From Day 3 to Day 6 post-vaccination, in a 10% random subset of participants. |
| |
| Gastrointestinal | General disorders | Systematic Assessment | From Day 3 to Day 6 post-vaccination, in a 10% random subset of participants. |
| |
| Headache | General disorders | Systematic Assessment | From Day 3 to Day 6 post-vaccination, in a 10% random subset of participants. |
| |
| Rash | General disorders | Systematic Assessment | From Day 3 to Day 6 post-vaccination, in a 10% random subset of participants. |
| |
| Fever | General disorders | Systematic Assessment | From Day 3 to Day 6 post-vaccination, in a 10% random subset of participants. |
| |
| Influenza | Infections and infestations | Non-systematic Assessment | Within 30 days (Days 0-29) after vaccination |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Within 30 days (Days 0-29) after vaccination |
| |
| Headache | Nervous system disorders | Non-systematic Assessment | Within 30 days (Days 0-29) after vaccination |
| |
| Menstruation irregular | Reproductive system and breast disorders | Non-systematic Assessment | From Month 0 up to Month 48 |
| |
| Influenza | Infections and infestations | Non-systematic Assessment | From Month 0 up to Month 48 |
| |
| Vaginal infection | Infections and infestations | Non-systematic Assessment | From Month 0 up to Month 48 |
| |
| Vulvovaginal candidiasis | Infections and infestations | Non-systematic Assessment | From Month 0 up to Month 48 |
| |
| Urinary tract infection | Infections and infestations | Non-systematic Assessment | From Month 0 up to Month 48 |
| |
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment | From Month 0 up to Month 48 |
| |
| Headache | Nervous system disorders | Non-systematic Assessment | From Month 0 up to Month 48 |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | From Month 0 up to Month 48 |
| |
| Gastrointestinal inflammation | Gastrointestinal disorders | Non-systematic Assessment | From Month 0 up to Month 48 |
| |
| Dengue fever | Infections and infestations | Non-systematic Assessment | From Month 0 up to Month 48 |
|
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.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D011230 | Precancerous Conditions |
| D002578 | Uterine Cervical Dysplasia |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C510352 | human papillomavirus vaccine, L1 type 16, 18 |
Not provided
Not provided
Not provided
| Male |
|
| HPV16 and/or 18 Associated CIN2+ (N=2635;2677) |
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