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You are here: Home / NEWS . . . . . . . . / Vaccines / HPV / Cervarix / Immunogenicity and Tolerability of V503 Versus GARDASIL

Immunogenicity and Tolerability of V503 Versus GARDASIL

March 4, 2011 By Jonathan Leave a Comment

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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Filed Under: Cervarix, Gardasil / Silgard, Pharmaceuticals Tagged With: Autoimmune Diseases, cervarix, Cervical Cancer HPV, HPV, Merck, pharmaceuticals, STD's, vaccinations, Vaccine Adverse Reactions

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