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

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.

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Key information

Conditions

Haemophilus Influenzae Type B Infection Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Haemophilus Infections Infections Pasteurellaceae Infections

Age range

2 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Moon's Pediatrics Clinic, Gyeonggi-do, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Haemophilus influenza type b conjugate vaccine

Biological

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.

Primary outcomes

Number of participants with Adverse Events 28 days following vaccination

Time frame: 29 days to 5 months

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Jul 28, 2011
Registry last updated: Dec 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed