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

NCT ID: NCT01404962

Last Updated: 2016-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

764 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Haemophilus Influenzae Type B Infection

Keywords

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group 1

Group Type OTHER

Haemophilus influenza type b conjugate vaccine

Intervention Type 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.

Interventions

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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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

2 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis Vaccines

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Moon's Pediatrics Clinic

Gyeonggi-do, , South Korea

Site Status

Wooriai Pediatrics clinic

Incheon, , South Korea

Site Status

KyungHee University Hospital

Seoul, , South Korea

Site Status

Hanil General Hospital

Seoul, , South Korea

Site Status

Yonsei Pediatrics Clinic

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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V37_11

Identifier Type: -

Identifier Source: org_study_id