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| ID | Type | Description | Link |
|---|---|---|---|
| 2004_081 |
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The primary purpose of the study is to determine if GARDASIL (V501) with four components is able to prevent cervical cancer, cervical dysplasia, including Cervical Intraepithelial Neoplasia (CIN)(Any Grade) and Adenocarcinoma In Situ (AIS), and genital warts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | V501 |
|
| 2 | Placebo Comparator | Placebo |
|
| 3 | Experimental | HPV 16 Monovalent Vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V501 | Biological | Final Manufactured Product (FMP) quadrivalent HPV vaccine, a 0.5 mL intramuscular injection given at Day 1, Month 2 and Month 6. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia (CIN)(Any Grade), Adenocarcinoma In Situ (AIS) or Cervical Cancer | Follow-up through end of study (4 years) | |
| Incidence of HPV 6/11/16/18-related External Genital Lesions (EGL) [Genital Warts, Vulvar/Vaginal Intraepithelial Neoplasia (Any Grade), Vulvar/Vaginal Cancer] | Follow-up through end of study (4 years) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19199546 | Background | Garland SM, Steben M, Sings HL, James M, Lu S, Railkar R, Barr E, Haupt RM, Joura EA. Natural history of genital warts: analysis of the placebo arm of 2 randomized phase III trials of a quadrivalent human papillomavirus (types 6, 11, 16, and 18) vaccine. J Infect Dis. 2009 Mar 15;199(6):805-14. doi: 10.1086/597071. | |
| 18313445 | Background |
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The study Protocol 013 (NCT00092521) (N =5759 total randomized) was comprised of two sub-studies: Protocol 011 (NCT00517309) (N=1877 total randomized) and Protocol 012 (NCT00092482) (N=3882 total randomized). Final safety data are presented in the results for Protocol 013 (NCT00092521): the final participant visit took place on 19 January 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine | The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent Human papillomavirus (HPV) vaccine. The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study. |
| FG001 | Group 2 - Base Study Monovalent HPV (Type 16) Vaccine | The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with the Monovalent (HPV 16) HPV vaccine. The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Monovalent (HPV 16) HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study. Group 2 Base Study Monovalent HPV (Type 16) Vaccine was not part of the pre-specified efficacy analysis population. |
| FG002 | Group 3 - Base Study Placebo | The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo. The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study. |
| FG003 | Group 4 - Quadrivalent Human Papillomavirus Vaccine Extension | This group includes subjects who entered the extension including subjects who in the base study received fewer than the full three doses of Quadrivalent HPV vaccine during the base study (i.e., subjects who received placebo in the base study; subjects who received monovalent [type 16] HPV vaccine in the base study, or subjects who received <=2 doses of quadrivalent HPV vaccine in the base study). Subjects who discontinued the base portion of the study could enter the extension portion of the study. In the extension period subjects designated as "Completed Period" are those who received three doses of quadrivalent HPV vaccine and completed all required follow-up visits. Subjects designated as "Not Completed" are those who: a) Received all three vaccinations, but did not complete follow-up; b) Did not receive all vaccinations, but completed follow-up, or c) Did not receive all vaccinations, and did not complete follow-up. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Vaccination (Day 1 Through Month 7) |
|
| ||||||||||||||||||
| Follow-Up (After Month 7) |
| |||||||||||||||||||
| Extension Study (Group 4) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine | The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine. The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia (CIN)(Any Grade), Adenocarcinoma In Situ (AIS) or Cervical Cancer | Per-protocol population: subjects must have no major protocol violations, must be seronegative to the relevant type at Day 1 and Polymerase Chain Reaction (PCR) negative to the relevant type through Month 7, and must provide follow-up data. Group 2 Base Study Monovalent HPV Vaccine was not part of the pre-specified efficacy analysis population. | Posted | Number | incidence rate per 100 person-years | Follow-up through end of study (4 years) |
|
Not provided
Number of subjects at risk included randomized subjects who had follow-up. For Group 4 (Extension), number of subjects at risk included those who received >=1 vaccination in the extension study. Both serious and Other AEs were collected in the base period and only serious AEs were collected in the extension period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine | The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine. The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Executive Vice President, Clinical and Quantitative Sciences | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D003218 | Condylomata Acuminata |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000068857 | Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 |
| D053918 | Papillomavirus Vaccines |
| ID | Term |
|---|---|
| D017778 | Vaccines, Combined |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Comparator: Placebo | Biological | a 0.5 mL intramuscular placebo injection given at Day 1, Month 2 and Month 6. |
|
| Human Papillomavirus (HPV) 16 Monovalent | Biological | HPV 16 Monovalent vaccine, a 0.5 mL intramuscular injection given at Day 1, Month 2 and Month 6. |
|
| Barr E, Gause CK, Bautista OM, Railkar RA, Lupinacci LC, Insinga RP, Sings HL, Haupt RM. Impact of a prophylactic quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle vaccine in a sexually active population of North American women. Am J Obstet Gynecol. 2008 Mar;198(3):261.e1-11. doi: 10.1016/j.ajog.2007.09.001. |
| 17494926 | Background | Garland SM, Hernandez-Avila M, Wheeler CM, Perez G, Harper DM, Leodolter S, Tang GW, Ferris DG, Steben M, Bryan J, Taddeo FJ, Railkar R, Esser MT, Sings HL, Nelson M, Boslego J, Sattler C, Barr E, Koutsky LA; Females United to Unilaterally Reduce Endo/Ectocervical Disease (FUTURE) I Investigators. Quadrivalent vaccine against human papillomavirus to prevent anogenital diseases. N Engl J Med. 2007 May 10;356(19):1928-43. doi: 10.1056/NEJMoa061760. |
| 17512854 | Background | Joura EA, Leodolter S, Hernandez-Avila M, Wheeler CM, Perez G, Koutsky LA, Garland SM, Harper DM, Tang GW, Ferris DG, Steben M, Jones RW, Bryan J, Taddeo FJ, Bautista OM, Esser MT, Sings HL, Nelson M, Boslego JW, Sattler C, Barr E, Paavonen J. Efficacy of a quadrivalent prophylactic human papillomavirus (types 6, 11, 16, and 18) L1 virus-like-particle vaccine against high-grade vulval and vaginal lesions: a combined analysis of three randomised clinical trials. Lancet. 2007 May 19;369(9574):1693-702. doi: 10.1016/S0140-6736(07)60777-6. |
| 18489503 | Background | Insinga RP, Dasbach EJ, Allen SE, Carides GW, Myers ER. Reductions in human papillomavirus-disease resource use and costs with quadrivalent human papillomavirus (types 6, 11, 16, and 18) recombinant vaccination: the FUTURE Study Economic Evaluation. Value Health. 2008 Dec;11(7):1022-32. doi: 10.1111/j.1524-4733.2008.00342.x. Epub 2008 May 16. |
| 18000825 | Background | Perez G, Lazcano-Ponce E, Hernandez-Avila M, Garcia PJ, Munoz N, Villa LL, Bryan J, Taddeo FJ, Lu S, Esser MT, Vuocolo S, Sattler C, Barr E. Safety, immunogenicity, and efficacy of quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like-particle vaccine in Latin American women. Int J Cancer. 2008 Mar 15;122(6):1311-8. doi: 10.1002/ijc.23260. |
| 18008221 | Background | FUTURE II Study Group. Prophylactic efficacy of a quadrivalent human papillomavirus (HPV) vaccine in women with virological evidence of HPV infection. J Infect Dis. 2007 Nov 15;196(10):1438-46. doi: 10.1086/522864. Epub 2007 Oct 31. |
| 17544766 | Background | Ault KA; Future II Study Group. Effect of prophylactic human papillomavirus L1 virus-like-particle vaccine on risk of cervical intraepithelial neoplasia grade 2, grade 3, and adenocarcinoma in situ: a combined analysis of four randomised clinical trials. Lancet. 2007 Jun 2;369(9576):1861-1868. doi: 10.1016/S0140-6736(07)60852-6. |
| 17955433 | Background | Giuliano AR, Lazcano-Ponce E, Villa L, Nolan T, Marchant C, Radley D, Golm G, McCarroll K, Yu J, Esser MT, Vuocolo SC, Barr E. Impact of baseline covariates on the immunogenicity of a quadrivalent (types 6, 11, 16, and 18) human papillomavirus virus-like-particle vaccine. J Infect Dis. 2007 Oct 15;196(8):1153-62. doi: 10.1086/521679. Epub 2007 Sep 17. |
| 19505910 | Background | Garland SM, Insinga RP, Sings HL, Haupt RM, Joura EA. Human papillomavirus infections and vulvar disease development. Cancer Epidemiol Biomarkers Prev. 2009 Jun;18(6):1777-84. doi: 10.1158/1055-9965.EPI-09-0067. |
| 41166720 | Derived | Joura E, Kjaer SK, Bautista O, Luxembourg A, Saah A, Giuliano A. Effect of Prior 9-Valent Human Papillomavirus Vaccination on Subsequent Lower Genital Tract Dysplasia After Cervical Excisional Surgery. Obstet Gynecol. 2026 Jan 1;147(1):73-82. doi: 10.1097/AOG.0000000000006113. Epub 2025 Oct 30. |
| 32184277 | Derived | Doshi P, Bourgeois F, Hong K, Jones M, Lee H, Shamseer L, Spence O, Jefferson T. Adjuvant-containing control arms in pivotal quadrivalent human papillomavirus vaccine trials: restoration of previously unpublished methodology. BMJ Evid Based Med. 2020 Dec;25(6):213-219. doi: 10.1136/bmjebm-2019-111331. Epub 2020 Mar 17. |
| 30982556 | Derived | Giuliano AR, Joura EA, Garland SM, Huh WK, Iversen OE, Kjaer SK, Ferenczy A, Kurman RJ, Ronnett BM, Stoler MH, Bautista OM, Moeller E, Ritter M, Shields C, Luxembourg A. Nine-valent HPV vaccine efficacy against related diseases and definitive therapy: comparison with historic placebo population. Gynecol Oncol. 2019 Jul;154(1):110-117. doi: 10.1016/j.ygyno.2019.03.253. Epub 2019 Apr 11. |
| 29995724 | Derived | Garland SM, Joura EA, Ault KA, Bosch FX, Brown DR, Castellsague X, Ferenczy A, Ferris DG, Giuliano AR, Hernandez-Avila M, Huh WK, Iversen OE, Kjaer SK, Kurman RJ, Luna J, Monsonego J, Munoz N, Paavonen J, Pitisuttihum P, Ronnett BM, Steben M, Stoler MH, Wheeler CM, Wiley DJ, Perez G, Saah AJ, Luxembourg A, Li S, DiNubile MJ, Wagner M, Velicer C. Human Papillomavirus Genotypes From Vaginal and Vulvar Intraepithelial Neoplasia in Females 15-26 Years of Age. Obstet Gynecol. 2018 Aug;132(2):261-270. doi: 10.1097/AOG.0000000000002736. |
| 29074187 | Derived | Castellsague X, Ault KA, Bosch FX, Brown D, Cuzick J, Ferris DG, Joura EA, Garland SM, Giuliano AR, Hernandez-Avila M, Huh W, Iversen OE, Kjaer SK, Luna J, Monsonego J, Munoz N, Myers E, Paavonen J, Pitisuttihum P, Steben M, Wheeler CM, Perez G, Saah A, Luxembourg A, Sings HL, Velicer C. Human papillomavirus detection in cervical neoplasia attributed to 12 high-risk human papillomavirus genotypes by region. Papillomavirus Res. 2016 Dec;2:61-69. doi: 10.1016/j.pvr.2016.03.002. Epub 2016 Mar 14. |
| 23299013 | Derived | Clark LR, Myers ER, Huh W, Joura EA, Paavonen J, Perez G, James MK, Sings HL, Haupt RM, Saah AJ, Garner EI. Clinical trial experience with prophylactic human papillomavirus 6/11/16/18 vaccine in young black women. J Adolesc Health. 2013 Mar;52(3):322-9. doi: 10.1016/j.jadohealth.2012.07.003. Epub 2012 Aug 15. |
| 23066159 | Derived | Ruiz AM, Ruiz JE, Gavilanes AV, Eriksson T, Lehtinen M, Perez G, Sings HL, James MK, Haupt RM; FUTURE I and II Study Group. Proximity of first sexual intercourse to menarche and risk of high-grade cervical disease. J Infect Dis. 2012 Dec 15;206(12):1887-96. doi: 10.1093/infdis/jis612. Epub 2012 Oct 12. |
| 22454089 | Derived | Joura EA, Garland SM, Paavonen J, Ferris DG, Perez G, Ault KA, Huh WK, Sings HL, James MK, Haupt RM; FUTURE I and II Study Group. Effect of the human papillomavirus (HPV) quadrivalent vaccine in a subgroup of women with cervical and vulvar disease: retrospective pooled analysis of trial data. BMJ. 2012 Mar 27;344:e1401. doi: 10.1136/bmj.e1401. |
| 21491420 | Derived | Haupt RM, Wheeler CM, Brown DR, Garland SM, Ferris DG, Paavonen JA, Lehtinen MO, Steben M, Joura EA, Giacoletti KE, Radley DR, James MK, Saah AJ, Sings HL; FUTURE I and II Investigators. Impact of an HPV6/11/16/18 L1 virus-like particle vaccine on progression to cervical intraepithelial neoplasia in seropositive women with HPV16/18 infection. Int J Cancer. 2011 Dec 1;129(11):2632-42. doi: 10.1002/ijc.25940. Epub 2011 Apr 13. |
| 21471141 | Derived | Lehtinen M, Ault KA, Lyytikainen E, Dillner J, Garland SM, Ferris DG, Koutsky LA, Sings HL, Lu S, Haupt RM, Paavonen J; FUTURE I and II Study Group. Chlamydia trachomatis infection and risk of cervical intraepithelial neoplasia. Sex Transm Infect. 2011 Aug;87(5):372-6. doi: 10.1136/sti.2010.044354. Epub 2011 Apr 6. |
| 20949623 | Derived | Ault KA, Joura EA, Kjaer SK, Iversen OE, Wheeler CM, Perez G, Brown DR, Koutsky LA, Garland SM, Olsson SE, Tang GW, Ferris DG, Paavonen J, Steben M, Bosch FX, Majewski S, Munoz N, Sings HL, Harkins K, Rutkowski MA, Haupt RM, Garner EI; FUTURE I and II Study Group. Adenocarcinoma in situ and associated human papillomavirus type distribution observed in two clinical trials of a quadrivalent human papillomavirus vaccine. Int J Cancer. 2011 Mar 15;128(6):1344-53. doi: 10.1002/ijc.25723. Epub 2011 Jan 12. |
| 20647284 | Derived | FUTURE I/II Study Group; Dillner J, Kjaer SK, Wheeler CM, Sigurdsson K, Iversen OE, Hernandez-Avila M, Perez G, Brown DR, Koutsky LA, Tay EH, Garcia P, Ault KA, Garland SM, Leodolter S, Olsson SE, Tang GW, Ferris DG, Paavonen J, Lehtinen M, Steben M, Bosch FX, Joura EA, Majewski S, Munoz N, Myers ER, Villa LL, Taddeo FJ, Roberts C, Tadesse A, Bryan JT, Maansson R, Lu S, Vuocolo S, Hesley TM, Barr E, Haupt R. Four year efficacy of prophylactic human papillomavirus quadrivalent vaccine against low grade cervical, vulvar, and vaginal intraepithelial neoplasia and anogenital warts: randomised controlled trial. BMJ. 2010 Jul 20;341:c3493. doi: 10.1136/bmj.c3493. |
| 19935017 | Derived | Garland SM, Ault KA, Gall SA, Paavonen J, Sings HL, Ciprero KL, Saah A, Marino D, Ryan D, Radley D, Zhou H, Haupt RM, Garner EIO; Quadrivalent Human Papillomavirus Vaccine Phase III Investigators. Pregnancy and infant outcomes in the clinical trials of a human papillomavirus type 6/11/16/18 vaccine: a combined analysis of five randomized controlled trials. Obstet Gynecol. 2009 Dec;114(6):1179-1188. doi: 10.1097/AOG.0b013e3181c2ca21. |
| 19236279 | Derived | Brown DR, Kjaer SK, Sigurdsson K, Iversen OE, Hernandez-Avila M, Wheeler CM, Perez G, Koutsky LA, Tay EH, Garcia P, Ault KA, Garland SM, Leodolter S, Olsson SE, Tang GW, Ferris DG, Paavonen J, Steben M, Bosch FX, Dillner J, Joura EA, Kurman RJ, Majewski S, Munoz N, Myers ER, Villa LL, Taddeo FJ, Roberts C, Tadesse A, Bryan J, Lupinacci LC, Giacoletti KE, Sings HL, James M, Hesley TM, Barr E. The impact of quadrivalent human papillomavirus (HPV; types 6, 11, 16, and 18) L1 virus-like particle vaccine on infection and disease due to oncogenic nonvaccine HPV types in generally HPV-naive women aged 16-26 years. J Infect Dis. 2009 Apr 1;199(7):926-35. doi: 10.1086/597307. |
| 19236277 | Derived | Wheeler CM, Kjaer SK, Sigurdsson K, Iversen OE, Hernandez-Avila M, Perez G, Brown DR, Koutsky LA, Tay EH, Garcia P, Ault KA, Garland SM, Leodolter S, Olsson SE, Tang GW, Ferris DG, Paavonen J, Steben M, Bosch FX, Dillner J, Joura EA, Kurman RJ, Majewski S, Munoz N, Myers ER, Villa LL, Taddeo FJ, Roberts C, Tadesse A, Bryan J, Lupinacci LC, Giacoletti KE, James M, Vuocolo S, Hesley TM, Barr E. The impact of quadrivalent human papillomavirus (HPV; types 6, 11, 16, and 18) L1 virus-like particle vaccine on infection and disease due to oncogenic nonvaccine HPV types in sexually active women aged 16-26 years. J Infect Dis. 2009 Apr 1;199(7):936-44. doi: 10.1086/597309. |
| 19116707 | Derived | Six L, Leodolter S, Sings HL, Barr E, Haupt R, Joura EA. Prevalence of human papillomavirus types 6, 11, 16 and 18 in young Austrian women - baseline data of a phase III vaccine trial. Wien Klin Wochenschr. 2008;120(21-22):666-71. doi: 10.1007/s00508-008-1093-3. |
| 18164106 | Derived | Wheeler CM, Bautista OM, Tomassini JE, Nelson M, Sattler CA, Barr E; Protocol 11 study Investigators. Safety and immunogenicity of co-administered quadrivalent human papillomavirus (HPV)-6/11/16/18 L1 virus-like particle (VLP) and hepatitis B (HBV) vaccines. Vaccine. 2008 Jan 30;26(5):686-96. doi: 10.1016/j.vaccine.2007.11.043. Epub 2007 Dec 5. |
| Adverse Event |
|
| Death |
|
| Lost to Follow-up |
|
| Pregnancy |
|
| Withdrawal by Subject |
|
| Moved |
|
| Unblinded |
|
| New Medical History (Not AE) |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Initiated Extension Study |
|
| Received >=1 Dose in Extension Study |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG001 | Group 2 - Base Study Monovalent HPV (Type 16) Vaccine | The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with the Monovalent (HPV 16) HPV vaccine. The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Monovalent (HPV 16) HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study. |
| BG002 | Group 3 - Base Study Placebo | The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo. The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Age, Continuous | Median | Full Range | Years |
|
| Age, Customized | Although the upper age limit for this study was 23 years old, four subjects aged 24 were randomized into the study. | Number | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| OG001 | Group 3 - Base Study Placebo | The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo. The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study. |
|
|
|
| Primary | Incidence of HPV 6/11/16/18-related External Genital Lesions (EGL) [Genital Warts, Vulvar/Vaginal Intraepithelial Neoplasia (Any Grade), Vulvar/Vaginal Cancer] | Per-protocol population: subjects must have no major protocol violations, must be seronegative to the relevant type at Day 1 and PCR negative to the relevant type through Month 7, and must provide follow-up data. Group 2 Base Study Monovalent HPV (Type 16) Vaccine was not part of the pre-specified efficacy analysis population. | Posted | Number | incidence rate per 100 person-years | Follow-up through end of study (4 years) |
|
|
|
|
| 50 |
| 2,673 |
| 2,458 |
| 2,673 |
| EG001 | Group 2 - Base Study Monovalent HPV (Type 16) Vaccine | The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with the Monovalent (HPV 16) HPV vaccine. The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Monovalent (HPV 16) HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study. | 4 | 299 | 276 | 299 |
| EG002 | Group 3 - Base Study Placebo | The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo. The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study. | 45 | 2,672 | 2,331 | 2,672 |
| EG003 | Group 4 - Quadrivalent Human Papillomavirus Vaccine Extension | This group includes subjects who entered the extension including subjects who in the base study received fewer than the full three doses of Quadrivalent HPV vaccine during the base study (i.e., subjects who received placebo in the base study; subjects who received monovalent [type 16] HPV vaccine in the base study, or subjects who received <=2 doses of quadrivalent HPV vaccine in the base study). Subjects who discontinued the base portion of the study could enter the extension portion of the study. In the extension period subjects designated as "Completed Period" are those who received three doses of quadrivalent HPV vaccine and completed all required follow-up visits. Subjects designated as "Not Completed" are those who: a) Received all three vaccinations, but did not complete follow-up; b) Did not receive all vaccinations, but completed follow-up, or c) Did not receive all vaccinations, and did not complete follow-up. | 5 | 801 | 0 | 0 |
| Gastric Ulcer | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Allergy to vaccine | Immune system disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Anogenital warts | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Breast abscess | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Endometritis decidual | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Enterocolitis infectious | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Pelvic inflammatory disease | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Post procedural infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Tonsillitis streptococcal | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Varicella | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Abdominal injury | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
|
| Accidental poisoning | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
|
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
|
| Operative haemorrhage | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Facial palsy | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Transient ischemic attack | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Abortion threatened | Pregnancy, puerperium and perinatal conditions | MedDRA 11.1 | Systematic Assessment |
|
| Breech presentation | Pregnancy, puerperium and perinatal conditions | MedDRA 11.1 | Non-systematic Assessment |
|
| Cephalo-pelvic disproportion | Pregnancy, puerperium and perinatal conditions | MedDRA 11.1 | Non-systematic Assessment |
|
| Cervix dystocia | Pregnancy, puerperium and perinatal conditions | MedDRA 11.1 | Non-systematic Assessment |
|
| Failed induction of labor | Pregnancy, puerperium and perinatal conditions | MedDRA 11.1 | Non-systematic Assessment |
|
| Failed trial of labor | Pregnancy, puerperium and perinatal conditions | MedDRA 11.1 | Non-systematic Assessment |
|
| Fetal distress syndrome | Pregnancy, puerperium and perinatal conditions | MedDRA 11.1 | Non-systematic Assessment |
|
| Fetal malposition | Pregnancy, puerperium and perinatal conditions | MedDRA 11.1 | Non-systematic Assessment |
|
| Oligohydramnios | Pregnancy, puerperium and perinatal conditions | MedDRA 11.1 | Non-systematic Assessment |
|
| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | MedDRA 11.1 | Non-systematic Assessment |
|
| Premature labor | Pregnancy, puerperium and perinatal conditions | MedDRA 11.1 | Non-systematic Assessment |
|
| Premature rupture of membranes | Pregnancy, puerperium and perinatal conditions | MedDRA 11.1 | Non-systematic Assessment |
|
| Prolonged labor | Pregnancy, puerperium and perinatal conditions | MedDRA 11.1 | Non-systematic Assessment |
|
| Transverse presentation | Pregnancy, puerperium and perinatal conditions | MedDRA 11.1 | Non-systematic Assessment |
|
| Completed suicide | Psychiatric disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Cervix haemorrhage uterine | Reproductive system and breast disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Vulvovaginal candidiasis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Dysmenorrhea | Reproductive system and breast disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Pelvic Pain | Reproductive system and breast disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Injection site haematoma | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Injection site hypersensitivity | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 11.1 | Systematic Assessment |
|
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck 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.
| 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 |
| D030361 | Papillomavirus Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014860 | Warts |
| D017193 | Skin Diseases, Viral |
| D014412 | Tumor Virus Infections |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014765 |
| Viral Vaccines |