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

December 29, 2014 updated by: Merck Sharp & Dohme LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3055

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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:
  • Gardasil
  • V501
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:
  • Gardasil
  • V501
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:
  • Gardasil
  • V501
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:
  • Gardasil
  • V501

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Week 4 Postdose 3 (Month 7)
Geometric Mean Titer (GMT) for HPV 6 by Week 4 Postdose 3
Time Frame: Week 4 Postdose 3 (Month 7)
Week 4 Postdose 3 (Month 7)
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).
Week 4 Postdose 3 (Month 7)
Geometric Mean Titer (GMT) for HPV 11 by Week 4 Postdose 3
Time Frame: Week 4 Postdose 3 (Month 7)
Week 4 Postdose 3 (Month 7)
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.
Week 4 Postdose 3 (Month 7)
Geometric Mean Titer (GMT) for HPV 16 by Week 4 Postdose 3
Time Frame: Week 4 Postdose 3 (Month 7)
Week 4 Postdose 3 (Month 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).
Week 4 Postdose 3 (Month 7)
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).
Week 4 Postdose 3 (Month 7)
Geometric Mean Titer (GMT) for HPV 18 by Week 4 Postdose 3
Time Frame: Week 4 Postdose 3 (Month 7)
Week 4 Postdose 3 (Month 7)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2002

Primary Completion (Actual)

September 1, 2004

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

September 22, 2004

First Submitted That Met QC Criteria

September 24, 2004

First Posted (Estimate)

September 27, 2004

Study Record Updates

Last Update Posted (Estimate)

January 13, 2015

Last Update Submitted That Met QC Criteria

December 29, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V501-016
  • 2004_083

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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