V501 Immunogenicity Study in Females Age 9 to 17 Years (V501-028)

Study Overview
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Brief Summary
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The study evaluates the immunogenicity, safety and tolerability of V501 in preadolescent females

Official Title
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V501 Phase II Immunogenicity Study in Females Aged 9 to 17 Years

Conditions
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HPV Infections

Intervention / Treatment
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* Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)
* Biological: Comparator: Placebo (unspecified)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Virginal Female Subject Aged 9 To 17 Years Exclusion Criteria: Male Subject

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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Female

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: V501<br>V501 vaccination Quadrivalent HPV (Types 6, 11, 16, 18) L1 VLP Vaccine Injection cervix cancer exgenlesion Vaccination at Day 1, Month 2, and Month 6. Total 3 vaccinations. 0.5 mL intramuscular dose of V501 (HPV L1 Virus-Like Particle [VLP] Type 6, Type 11, Type 16, Type 18) or placebo at Day 1, Month 2 and Month 6. | Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)<br>* V501; Gardasil, 0.5 ml injection in 3 dosing regimen<br>* Other names: Gardasil;|
| Placebo Comparator: Placebo<br>Placebo vaccination, Placebo 0.5 ml injection in 3 dosing regimen | Biological: Comparator: Placebo (unspecified)<br>* Placebo 0.5 ml injection in 3 dosing regimen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Human Papilloma Virus (HPV) 6 Serum Antibody Titer at One Month After Completed Vaccination Series | Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers (GMT) by vaccine group. The limit of detection of the assay was 7 mMU/ml. GMTs and confidence limits below the limit of detection are shown as 7.0. | At one month after completed vaccination series (Month 7) | 
| Human Papilloma Virus (HPV) 11 Serum Antibody Titer at One Month After Completed Vaccination Series | Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers by vaccine group. The limit of detection of the assay was 8 mMU/ml. GMTs and confidence limits below the limit of detection are shown as 8.0. | At one month after completed vaccination series (Month 7) | 
| Human Papilloma Virus (HPV) 16 Serum Antibody Titer at One Month After Completed Vaccination Series | Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers by vaccine group. The limit of detection of the assay was 11 mMU/ml. GMTs and confidence limits below the limit of detection are shown as 11.0. | At one month after completed vaccination series (Month 7) | 
| Human Papilloma Virus (HPV) 18 Serum Antibody Titer at One Month After Completed Vaccination Series | Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers by vaccine group. The limit of detection of the assay was 10 mMU/ml. GMTs and confidence limits below the limit of detection are shown as 10.0. | At one month after completed vaccination series (Month 7) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HPV 6, 11, 16 and 18 Serum Antibody Titer at 24 Month After Completed Vaccination Series | Month 30 HPV cLIA Geometric Mean Titers by vaccine group. | 24 month after completed vaccination series (Month 30) |