ClinicalTrials.gov
This study is currently recruiting participants.
Verified by Sanofi Pasteur MSD, February 2011
First Received: February 24, 2011 No Changes Posted
Purpose
Primary objective:
• To demonstrate that administration of V503 induces non-inferior Geometric Mean Titers (GMTs) (for serum anti-HPV16 and anti-HPV18) compared to GARDASIL.
Secondary objectives:
- To evaluate the tolerability of V503 in 9-15 year-old girls.
- To summarize humoral immune response (anti-HPV 6, 11, 16, 18) induced by V503 or GARDASIL.
| Condition | Intervention | Phase |
|---|---|---|
| Human Papillomavirus | Biological: 1 dose at Day 1, 1 dose at Month 2 and 1 dose at Month 6 | Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Control: Active Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | A Randomized, Double-Blinded, Controlled With GARDASIL (Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, Adsorbed)), Phase III Clinical Trial to Study the Immunogenicity and Tolerability of V503 (9-Valent Human Papillomavirus (HPV) Vaccine) in Preadolescent and Adolescent Girls (9- to 15-year-old) |
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