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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cervical Cancer, Genital Warts

Intervention / Treatment
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* Biological: V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 23 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>100% Formulation qHPV Vaccine | Biological: V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine<br>* qHPV Vaccine (20, 40, 60 or 100% dose formulation) 0.5 mL intramuscular injection given at Day 1, Month 2 and Month 6.<br>* Other names: Gardasil;|
| Experimental: 2<br>60% Formulation qHPV Vaccine | Biological: V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine<br>* qHPV Vaccine (20, 40, 60 or 100% dose formulation) 0.5 mL intramuscular injection given at Day 1, Month 2 and Month 6.<br>* Other names: Gardasil;|
| Experimental: 3<br>40% Formulation qHPV Vaccine | Biological: V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine<br>* qHPV Vaccine (20, 40, 60 or 100% dose formulation) 0.5 mL intramuscular injection given at Day 1, Month 2 and Month 6.<br>* Other names: Gardasil;|
| Experimental: 4<br>20% Formulation qHPV Vaccine | Biological: V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine<br>* qHPV Vaccine (20, 40, 60 or 100% dose formulation) 0.5 mL intramuscular injection given at Day 1, Month 2 and Month 6.<br>* Other names: Gardasil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3 | 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 |  | Week 4 Postdose 3 (Month 7) | 
| Number of Subjects Who Seroconverted for HPV 11 by Week 4 Postdose 3 | 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 |  | Week 4 Postdose 3 (Month 7) | 
| Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3 | 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 |  | Week 4 Postdose 3 (Month 7) | 
| Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3 | 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 | 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 |  | Week 4 Postdose 3 (Month 7) |