HPV Infections Clinical Trial
Official title:
V501 Phase II Efficacy Study in Women Aged 18 to 26
A study to evaluate the efficacy, immunogenicity, safety and tolerability of V501 in adult women
Status | Completed |
Enrollment | 1021 |
Est. completion date | September 2009 |
Est. primary completion date | September 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 26 Years |
Eligibility |
Inclusion Criteria: - Female Subject Aged 18 To 26 Years - With 1-4 Lifetime Sexual Partners Exclusion Criteria: - Male Subject |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Merck Sharp & Dohme Corp. |
Yoshikawa H, Ebihara K, Tanaka Y, Noda K. Efficacy of quadrivalent human papillomavirus (types 6, 11, 16 and 18) vaccine (GARDASIL) in Japanese women aged 18-26 years. Cancer Sci. 2013 Apr;104(4):465-72. doi: 10.1111/cas.12106. Epub 2013 Mar 7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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) | No |
Secondary | 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) | No |
Secondary | 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) | No |
Secondary | 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) | No |
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