V501 Efficacy Study in Women Aged 18 to 26 (V501-027)

Study Overview
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Brief Summary
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A study to evaluate the efficacy, immunogenicity, safety and tolerability of V501 in adult women

Official Title
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V501 Phase II Efficacy Study in Women Aged 18 to 26

Conditions
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HPV Infections

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female Subject Aged 18 To 26 Years With 1-4 Lifetime Sexual Partners Exclusion Criteria: Male Subject

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 26 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 |
| --- | --- |
| Placebo Comparator: 1<br>Placebo | Biological: Comparator: Placebo<br>* Placebo 0.5 ml injection in 3 dosing regimen<br>|
| Experimental: 2<br>Vaccine | Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine<br>* V501; Gardasil, 0.5 ml injection in 3 dosing regimen<br>* Other names: Gardasil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined Incidence of Persistent Human Papillomavirus (HPV) 6, 11, 16 and 18 Infection or HPV 6, 11, 16 and 18 Related-Disease as Determined by Clinical/Pathologic Criteria and Positive Polymerase Chain Reaction (PCR) Assay for Virus Subtype | Participants with HPV 6, 11, 16 or 18 persistent infection, and genital disease (e.g., cervical, vaginal or vulval intraepithelial neoplasia, or cancer, adenocarcinoma in situ and genital warts) per 100 person-years of follow up. | Over 30 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 6) | Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers (GMTs) 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) | 
| Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 11) | Month 7 HPV 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) | 
| Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 16) | Month 7 HPV 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) | 
| Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 18) | Month 7 HPV 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) |