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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01404962

Enrollment

764

Registered

2011-07-28

Start date

2011-08-31

Completion date

2012-07-31

Last updated

2016-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Haemophilus Influenzae Type B Infection

Keywords

Haemophilus influenza type b, children, Korea, vaccine, Prevention of haemophilus influenza type b

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.

Interventions

BIOLOGICALHaemophilus 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Months to 5 Years

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

Design outcomes

Primary

Measure	Time frame
Number of participants with Adverse Events 28 days following vaccination	29 days to 5 months

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026