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