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


Phase 2
9 Years
17 Years
Not Enrolling
Female
HPV Infections

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Trial Information

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


Inclusion Criteria:



- Virginal Female Subject Aged 9 To 17 Years

Exclusion Criteria:

- Male Subject

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

Human Papilloma Virus (HPV) 6 Serum Antibody Titer at One Month After Completed Vaccination Series

Outcome Description:

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".

Outcome Time Frame:

At one month after completed vaccination series (Month 7)

Safety Issue:

No

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Merck

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

V501-028

NCT ID:

NCT00411749

Start Date:

December 2006

Completion Date:

September 2009

Related Keywords:

  • HPV Infections

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