HPV Infections Clinical Trial
Official title:
V501 Phase II Immunogenicity Study in Females Aged 9 to 17 Years
The study evaluates the immunogenicity, safety and tolerability of V501 in preadolescent females
Status | Completed |
Enrollment | 107 |
Est. completion date | September 2009 |
Est. primary completion date | September 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 9 Years to 17 Years |
Eligibility |
Inclusion Criteria: - Virginal Female Subject Aged 9 To 17 Years 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 |
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Merck Sharp & Dohme Corp. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | No |
Primary | 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) | No |
Primary | 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) | No |
Primary | 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) | No |
Secondary | 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) | No |
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