NCT01404962

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
764

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 28, 2011

Completed
4 days until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

December 1, 2016

Status Verified

September 1, 2012

Enrollment Period

11 months

First QC Date

July 25, 2011

Last Update Submit

November 30, 2016

Conditions

Haemophilus Influenzae Type B Infection

Keywords

Haemophilus influenza type bchildrenKoreavaccinePrevention of haemophilus influenza type b

Outcome Measures

Primary Outcomes (1)

  • Number of participants with Adverse Events 28 days following vaccination

    29 days to 5 months

Study Arms (1)

Group 1

OTHER
Biological: Haemophilus influenza type b conjugate vaccine

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.

Group 1

Eligibility Criteria

Age2 Months - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Male and female children 2 months to 5 years of age scheduled to receive vaccination

You may not qualify if:

  • Contraindications to Vaxem™Hib Korean Prescribing information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Moon's Pediatrics Clinic

Gyeonggi-do, 449-812, South Korea

Location

Wooriai Pediatrics clinic

Incheon, 407-818, South Korea

Location

KyungHee University Hospital

Seoul, 130-702, South Korea

Location

Hanil General Hospital

Seoul, 132-703, South Korea

Location

Yonsei Pediatrics Clinic

Seoul, 134-734, South Korea

Location

MeSH Terms

Conditions

Haemophilus Infections

Condition Hierarchy (Ancestors)

Pasteurellaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2011

First Posted

July 28, 2011

Study Start

August 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

December 1, 2016

Record last verified: 2012-09

Locations

KR(5)