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

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

Official Title: A Phase I, Single-arm, Single-center Study to Investigate Safety and Reactogenicity of Monovalent Conjugated Vaccine Against Haemophilus Influenzae Type b in Healthy Child

Brief Summary: This study will investigate safety and reactogenicity of a monovalent conjugated vaccine against Haemophilus influenzae type b in healthy children

Detailed Summary:
Sponsor: Novartis Vaccines

Current Primary Outcome: Rates of local and systemic reactions, adverse events (AEs), and serious adverse events (SAEs) after first vaccination dose will be evaluated. [ Time Frame: 30 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 second vaccination dose will be evaluated. [ Time Frame: 90 days ]

Original Secondary Outcome: Same as current

Information By: Novartis

Dates:
Date Received: August 12, 2008
Date Started: July 2008
Date Completion:
Last Updated: February 6, 2012
Last Verified: February 2012