Broad Spectrum HPV Vaccine Dose Ranging Study (V502-001)

Phase 2

Completed

• Conditions: Cervical Cancer; HPV; Premalignancy Anogenital Warts

• Registration Number: NCT00260039
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

This dose-ranging study is to evaluate an investigational vaccine with the following objectives: (1) To demonstrate that the vaccine is well-tolerated in women (2) To evaluate immune responses in women who are between 16 and 23 years of age at enrollment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-11-28
• Study First Submitted QC: 2005-11-28
• Study Start: 2005-12
• Study First Posted: 2005-12-01
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-05
• Last Update Posted: 2015-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 680

Inclusion Criteria

• Lifetime history of 0-4 sexual partners

Exclusion Criteria

• History of abnormal PAP test or abnormal cervical biopsy result; history of external genital/vaginal warts; history of positive HPV test

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The octavalent HPV VLP vaccine, when administered in a 3-dose regimen, induces acceptable responses for specific HPV types at 4 weeks Post dose 3. Immune responses measured by an HPV competitive Luminex immunoassay.	4 weeks post dose 3 injection