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