Clinical trial NCT00092495: Study of an Investigational Vaccine in Pre-Adolescents and Adolescents (Gardasil)(V501-016)
Official title: A Study to Demonstrate Immunogenicity and Tolerability of Gardasil (V501) Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Preadolescents, and To Determine End-Expiry Specifications for the Vaccine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cervical Cancer
Genital Warts
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2004-09-27
Enrollment: 3055
Sex: ALL
Minimum age (years): 10
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary purpose of the study is to determine if an investigational vaccine Gardasil (V501) with 4 components will provide an immune response and will be well tolerated in pre-adolescents and adolescents.


Eligibility criteria: Inclusion Criteria:

* Healthy adolescents and pre-adolescents with no prior sexual history
* Healthy women who have an intact uterus with lifetime history of 0-4 sexual partners

Exclusion Criteria:

* Prior Human Papillomavirus (HPV) vaccination
* Prior abnormal Paps
* Prior history of genital warts

Primary outcomes:
measure: Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3
timeFrame: Week 4 Postdose 3 (Month 7)
measure: Geometric Mean Titer (GMT) for HPV 6 by Week 4 Postdose 3
timeFrame: Week 4 Postdose 3 (Month 7)
measure: Number of Subjects Who Seroconverted for HPV 11 by Week 4 Postdose 3
timeFrame: Week 4 Postdose 3 (Month 7)
measure: Geometric Mean Titer (GMT) for HPV 11 by Week 4 Postdose 3
timeFrame: Week 4 Postdose 3 (Month 7)
measure: Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3
timeFrame: Week 4 Postdose 3 (Month 7)
measure: Geometric Mean Titer (GMT) for HPV 16 by Week 4 Postdose 3
timeFrame: Week 4 Postdose 3 (Month 7)
measure: Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3
timeFrame: Week 4 Postdose 3 (Month 7)
measure: Number of Subjects Who Seroconverted for HPV 18 by Week 4 Postdose 3
timeFrame: Week 4 Postdose 3 (Month 7)
measure: Geometric Mean Titer (GMT) for HPV 18 by Week 4 Postdose 3
timeFrame: Week 4 Postdose 3 (Month 7)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Block SL, Nolan T, Sattler C, Barr E, Giacoletti KE, Marchant CD, Castellsague X, Rusche SA, Lukac S, Bryan JT, Cavanaugh PF Jr, Reisinger KS; Protocol 016 Study Group. Comparison of the immunogenicity and reactogenicity of a prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in male and female adolescents and young adult women. Pediatrics. 2006 Nov;118(5):2135-45. doi: 10.1542/peds.2006-0461.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Majewski S, Bosch FX, Dillner J, Iversen OE, Kjaer SK, Munoz N, Olsson SE, Paavonen J, Sigurdsson K, Bryan J, Esser MT, Giacoletti K, James M, Taddeo F, Vuocolo S, Barr E. The impact of a quadrivalent human papillomavirus (types 6, 11, 16, 18) virus-like particle vaccine in European women aged 16 to 24. J Eur Acad Dermatol Venereol. 2009 Oct;23(10):1147-55. doi: 10.1111/j.1468-3083.2009.03266.x. Epub 2009 Apr 23.