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

Novartis Vaccines764 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

764

Conditions

Haemophilus Influenzae Type B Infection

Interventions

Haemophilus influenza type b conjugate vaccineBIOLOGICAL

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.

Eligibility

Sex: ALLMin age: 2 MonthsMax age: 5 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (5)

Moon's Pediatrics Clinic

Gyeonggi-do, South Korea

Wooriai Pediatrics clinic

Incheon, South Korea

KyungHee University Hospital

Seoul, South Korea

Hanil General Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Number of participants with Adverse Events 28 days following vaccination

Time frame: 29 days to 5 months

Data from ClinicalTrials.gov

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