Clinical Trial: Study in Infants (6-12 Months) Comparing Two Doses of a Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Vaccine Versus a Tetanus Toxoid-Conjugated Vaccine Available for the Prevention of Haemophilus Influenzae Type b Infections in China

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase III Observer-Blind, Randomized, Controlled, Single-Coordinating Center Pediatric Study in China Comparing Two Doses of a Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Vaccine Ve

Brief Summary: This study will evaluate the safety and efficacy of two doses of two commercially available vaccines used to prevent Haemophilus influenzae type b infections in children 6-12 months of age.

Detailed Summary:
Sponsor: Novartis Vaccines

Current Primary Outcome: Anti-PRP antibody levels at day 31 post last vaccination [ Time Frame: 30 days after last vaccination ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Solicited local and systemic reactions, AEs, and SAEs [ Time Frame: 30 days post last vaccination ]

Original Secondary Outcome: Same as current

Information By: Novartis

Dates:
Date Received: January 3, 2010
Date Started: April 2010
Date Completion:
Last Updated: December 27, 2011
Last Verified: December 2011