Clinical Trial: Safety of Haemophilus Influenza Type b Vaccine When Administered to Korean Children
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Post Marketing Surveillance Study to Monitor the Reactogenicity and Safety of Vaxem™Hib When Administered According to the Prescribing Information in Korea
Brief Summary: This is a multicenter, post marketing surveillance study which aims to evaluate the safety profile of haemophilus influenza type b vaccine when administered to Korean children according to the product insert.
Detailed Summary:
Sponsor: Novartis Vaccines
Current Primary Outcome: Number of participants with Adverse Events 28 days following vaccination [ Time Frame: 29 days to 5 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Novartis
Dates:
Date Received: July 25, 2011
Date Started: August 2011
Date Completion:
Last Updated: November 30, 2016
Last Verified: September 2012