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Clinical Trials/NCT01404962
NCT01404962
Completed
Phase 4

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

Novartis Vaccines5 sites in 1 country764 target enrollmentAugust 2011
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ConditionsHaemophilus Influenzae Type B Infection

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Haemophilus Influenzae Type B Infection
Sponsor
Novartis Vaccines
Enrollment
764
Locations
5
Primary Endpoint
Number of participants with Adverse Events 28 days following vaccination
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2011
End Date
July 2012
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Novartis Vaccines
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Number of participants with Adverse Events 28 days following vaccination

Time Frame: 29 days to 5 months

Study Sites (5)

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