Study of an Investigational Vaccine in Pre-Adolescents and Adolescents (Gardasil)(V501-016)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092495
First received: September 22, 2004
Last updated: January 28, 2014
Last verified: January 2014
  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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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: February 2009
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: 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: January 28, 2014
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 July 22, 2014