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

Phase 4

Completed

• Conditions: Haemophilus Influenzae Type B Infection
• Interventions: Biological: Haemophilus influenza type b conjugate vaccine

• Registration Number: NCT01404962
• Lead Sponsor: Novartis Vaccines

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 Description

Not available

Study Timeline

• Study First Submitted: 2011-07-25
• Study First Submitted QC: 2011-07-27
• Study First Posted: 2011-07-28
• Study Start: 2011-08
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2012-09
• Last Update Submitted: 2016-11-30
• Last Update Posted: 2016-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 764

Inclusion Criteria

• Male and female children 2 months to 5 years of age scheduled to receive vaccination

Exclusion Criteria

• Contraindications to Vaxem™Hib Korean Prescribing information

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group 1	Haemophilus influenza type b conjugate vaccine	-

Primary Outcome Measures

Name	Time	Method
Number of participants with Adverse Events 28 days following vaccination	29 days to 5 months

Trial Locations

Locations (5)

Wooriai Pediatrics clinic; 🇰🇷 Incheon, Korea, Republic of

KyungHee University Hospital; 🇰🇷 Seoul, Korea, Republic of

Hanil General Hospital; 🇰🇷 Seoul, Korea, Republic of

Yonsei Pediatrics Clinic; 🇰🇷 Seoul, Korea, Republic of

Moon's Pediatrics Clinic; 🇰🇷 Gyeonggi-do, Korea, Republic of