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

Sponsor

Novartis Vaccines (Industry)

Overall Status

Completed

CT.gov ID

NCT01404962

Collaborator

(none)

764

Enrollment

Locations

Arm

Duration (Months)

152.8

Patients Per Site

13.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Haemophilus Influenzae Type B Infection	Biological: Haemophilus influenza type b conjugate vaccine	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

764 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Study Start Date :

Aug 1, 2011

Actual Primary Completion Date :

Jul 1, 2012

Actual Study Completion Date :

Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Other: Group 1	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.

Arm

Intervention/Treatment

Other: Group 1

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.

Outcome Measures

Primary Outcome Measures

Number of participants with Adverse Events 28 days following vaccination [29 days to 5 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Months to 5 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Moon's Pediatrics Clinic	Gyeonggi-do	Korea, Republic of	449-812
2	Wooriai Pediatrics clinic	Incheon	Korea, Republic of	407-818
3	KyungHee University Hospital	Seoul	Korea, Republic of	130-702
4	Hanil General Hospital	Seoul	Korea, Republic of	132-703
5	Yonsei Pediatrics Clinic	Seoul	Korea, Republic of	134-734