Clinical Trial: Study in Toddlers (12-18 Months) Comparing a Booster Dose of Vaxem Hib and Hiberix Vaccines 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 Open Label, Multi-Center Pediatric Study in China Comparing Booster Doses of Vaxem Hib and Hiberix Vaccines for the Prevention of Haemophilus Influenzae Type b

Brief Summary: This study will evaluate the safety and immunogenicity of booster doses of the two vaccines used to prevent Haemophilus influenzae type b infections in children 12-18 months of age.

Detailed Summary:
Sponsor: Novartis Vaccines

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

Original Primary Outcome: Same as current

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

Original Secondary Outcome: Same as current

Information By: Novartis

Dates:
Date Received: December 2, 2009
Date Started: September 2009
Date Completion:
Last Updated: December 7, 2011
Last Verified: December 2011