Study of an Investigational Vaccine in Pre-Adolescents and Adolescents (Gardasil)(V501-016)(COMPLETED) - Full Text View

Purpose

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.

Condition	Intervention	Phase
Cervical Cancer Genital Warts	Biological: V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Cervical Cancer Genital Warts Warts

Drug Information available for: Human Papillomaviruses

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3 [ Time Frame: Week 4 Postdose 3 (Month 7) ] [ Designated as safety issue: No ]
Seroconversion is defined as going from seronegative to seropositive.

Seropositivity is defined as an anti-HPV 6 titer ≥ 20 milliMerck units per milliliter (mMU/mL).
Geometric Mean Titer (GMT) for HPV 6 by Week 4 Postdose 3 [ Time Frame: Week 4 Postdose 3 (Month 7) ] [ Designated as safety issue: No ]
Number of Subjects Who Seroconverted for HPV 11 by Week 4 Postdose 3 [ Time Frame: Week 4 Postdose 3 (Month 7) ] [ Designated as safety issue: No ]
Seroconversion is defined as going from seronegative to seropositive.

Seropositivity is defined as an anti-HPV 11 titer ≥ 16 milliMerck units per milliliter (mMU/mL).
Geometric Mean Titer (GMT) for HPV 11 by Week 4 Postdose 3 [ Time Frame: Week 4 Postdose 3 (Month 7) ] [ Designated as safety issue: No ]
Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3 [ Time Frame: Week 4 Postdose 3 (Month 7) ] [ Designated as safety issue: No ]
Seropositivity is defined as an anti-HPV 16 titer ≥ 20 milliMerck units per milliliter (mMU/mL). Seroconversion is defined as going from seronegative to seropositive.
Geometric Mean Titer (GMT) for HPV 16 by Week 4 Postdose 3 [ Time Frame: Week 4 Postdose 3 (Month 7) ] [ Designated as safety issue: No ]
Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3 [ Time Frame: Week 4 Postdose 3 (Month 7) ] [ Designated as safety issue: No ]
Seroconversion is defined as going from seronegative to seropositive.

Seropositivity is defined as an anti-HPV 16 titer ≥ 20 milliMerck units per milliliter (mMU/mL).
Number of Subjects Who Seroconverted for HPV 18 by Week 4 Postdose 3 [ Time Frame: Week 4 Postdose 3 (Month 7) ] [ Designated as safety issue: No ]
Seroconversion is defined as going from seronegative to seropositive.

Seropositivity is defined as an anti-HPV 18 titer ≥ 24 milliMerck units per milliliter (mMU/mL).
Geometric Mean Titer (GMT) for HPV 18 by Week 4 Postdose 3 [ Time Frame: Week 4 Postdose 3 (Month 7) ] [ Designated as safety issue: No ]

Enrollment:	3055
Study Start Date:	December 2002
Study Completion Date:	September 2004
Primary Completion Date:	September 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 100% Formulation qHPV Vaccine	Biological: V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine qHPV Vaccine (20, 40, 60 or 100% dose formulation) 0.5 mL intramuscular injection given at Day 1, Month 2 and Month 6. Other Names: V501 Gardasil
Experimental: 2 60% Formulation qHPV Vaccine	Biological: V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine qHPV Vaccine (20, 40, 60 or 100% dose formulation) 0.5 mL intramuscular injection given at Day 1, Month 2 and Month 6. Other Names: V501 Gardasil
Experimental: 3 40% Formulation qHPV Vaccine	Biological: V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine qHPV Vaccine (20, 40, 60 or 100% dose formulation) 0.5 mL intramuscular injection given at Day 1, Month 2 and Month 6. Other Names: V501 Gardasil
Experimental: 4 20% Formulation qHPV Vaccine	Biological: V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine qHPV Vaccine (20, 40, 60 or 100% dose formulation) 0.5 mL intramuscular injection given at Day 1, Month 2 and Month 6. Other Names: V501 Gardasil

Eligibility

Ages Eligible for Study:	10 Years to 23 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00092495

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

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.

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.

Perez G, Lazcano-Ponce E, Hernandez-Avila M, García PJ, Muñoz 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.

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. Epub 2007 Sep 17.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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 EI; 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):1179-88.

Majewski S, Bosch FX, Dillner J, Iversen OE, Kjaer SK, Muñoz 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. Epub 2009 Apr 23.

Responsible Party:	Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00092495 History of Changes
Other Study ID Numbers:	V501-016, 2004_083
Study First Received:	September 22, 2004
Results First Received:	February 15, 2010
Last Updated:	May 20, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Uterine Cervical Neoplasms
Condylomata Acuminata
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on May 19, 2013