NCT01404962

Safety of Haemophilus Influenza Type b Vaccine When Administered to Korean Children

A Post Marketing Surveillance Study to Monitor the Reactogenicity and Safety of Vaxem™Hib When Administered According to the Prescribing Information in Korea

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 764 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 2 Months – 5 Years
• Healthy volunteers: Accepted

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.

Conditions

• Haemophilus Influenzae Type B Infection

Interventions

Type	Name	Description
BIOLOGICAL	Haemophilus influenza type b conjugate vaccine	Primary series is 3 doses given to infants beginning at 2 months of age with an interval of 2 months apart (i.e. 2, 4 and 6 months of age). Booster vaccination consists of 1 dose and is given to toddlers 16 to 20 months of age. In this study, subjects will receive vaccination from routine primary care.

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2011-07-28
• Last updated: 2016-12-01

Locations

5 sites across 1 country: South Korea