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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00092495
Recruitment Status : Completed
First Posted : September 27, 2004
Results First Posted : March 8, 2010
Last Update Posted : January 13, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
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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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3055 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : December 2002
Actual Primary Completion Date : September 2004
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3 [ Time Frame: Week 4 Postdose 3 (Month 7) ]

    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).


  2. Geometric Mean Titer (GMT) for HPV 6 by Week 4 Postdose 3 [ Time Frame: Week 4 Postdose 3 (Month 7) ]
  3. Number of Subjects Who Seroconverted for HPV 11 by Week 4 Postdose 3 [ Time Frame: Week 4 Postdose 3 (Month 7) ]

    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).


  4. Geometric Mean Titer (GMT) for HPV 11 by Week 4 Postdose 3 [ Time Frame: Week 4 Postdose 3 (Month 7) ]
  5. Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3 [ Time Frame: Week 4 Postdose 3 (Month 7) ]
    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.

  6. Geometric Mean Titer (GMT) for HPV 16 by Week 4 Postdose 3 [ Time Frame: Week 4 Postdose 3 (Month 7) ]
  7. Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3 [ Time Frame: Week 4 Postdose 3 (Month 7) ]

    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).


  8. Number of Subjects Who Seroconverted for HPV 18 by Week 4 Postdose 3 [ Time Frame: Week 4 Postdose 3 (Month 7) ]

    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).


  9. Geometric Mean Titer (GMT) for HPV 18 by Week 4 Postdose 3 [ Time Frame: Week 4 Postdose 3 (Month 7) ]

Eligibility Criteria
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Ages Eligible for Study:   10 Years to 23 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00092495


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

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

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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00092495    
Other Study ID Numbers: V501-016
2004_083
First Posted: September 27, 2004    Key Record Dates
Results First Posted: March 8, 2010
Last Update Posted: January 13, 2015
Last Verified: December 2014
Additional relevant MeSH terms:
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Condylomata Acuminata
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Communicable Diseases
Infections
Warts
Papillomavirus Infections
 DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases