Clinical Trial: Safety and Immunogenicity of a Monovalent Conjugated Vaccine Against Haemophilus Influenzae Type b

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

Official Title: A Phase III, Observer-blind, Randomized, Controlled, Multicenter Study to Investigate Immunogenicity and Safety of Haemophilus Influenzae Type b Vaccine in 2 - 4 Months Ol

Brief Summary: This study will investigate safety and immunogenicity of a monovalent conjugated vaccine against Haemophilus influenzae type b in healthy children aged 2 to 4 months in China.

Detailed Summary:
Sponsor: Novartis Vaccines

Current Primary Outcome: Immunogenic response measured by detection of anti-PRP antibodies by IgG enzyme linked immunosorbent assay (ELISA). [ Time Frame: 90 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Rates of local and systemic reactions, adverse events (AEs), and serious adverse events (SAEs) after each single vaccination dose will be evaluated. [ Time Frame: 90 days ]

Original Secondary Outcome: Same as current

Information By: Novartis

Dates:
Date Received: December 12, 2008
Date Started: November 2008
Date Completion:
Last Updated: December 26, 2011
Last Verified: December 2011