Clinical Trial: Immunogenicity and Safety of a Booster Dose of Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 365-569 Days Old Healthy Infants

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

Official Title: A Phase III Observer Blind Single-Coordinating Center Pediatric Study in China Comparing a Booster Dose of Vaxem™ Hib to HIBERIX® When Given as Part of a Local

Brief Summary: This study will evaluate the safety and immunogenicity of booster dose of two commercially available vaccines used to prevent Haemophilus influenzae type b infections in children 365-569 days of age

Detailed Summary:
Sponsor: Novartis Vaccines

Current Primary Outcome: Anti-PRP (polyribosyl-ribitol-phosphate) 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, adverse events (AEs), and serious adverse events (SAEs) [ Time Frame: 30 days post last vaccination ]

Original Secondary Outcome: Same as current

Information By: Novartis

Dates:
Date Received: October 21, 2010
Date Started: October 2010
Date Completion:
Last Updated: December 27, 2011
Last Verified: December 2011