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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01404962
First Posted: July 28, 2011
Last Update Posted: December 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
  Purpose
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.

Condition Intervention Phase
Haemophilus Influenzae Type B Infection Biological: Haemophilus influenza type b conjugate vaccine Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Post Marketing Surveillance Study to Monitor the Reactogenicity and Safety of Vaxem™Hib When Administered According to the Prescribing Information in Korea

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Vaccines ):

Primary Outcome Measures:
  • Number of participants with Adverse Events 28 days following vaccination [ Time Frame: 29 days to 5 months ]

Enrollment: 764
Study Start Date: August 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group 1 Biological: 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01404962


Locations
Korea, Republic of
Moon's Pediatrics Clinic
Gyeonggi-do, Korea, Republic of, 449-812
Wooriai Pediatrics clinic
Incheon, Korea, Republic of, 407-818
KyungHee University Hospital
Seoul, Korea, Republic of, 130-702
Hanil General Hospital
Seoul, Korea, Republic of, 132-703
Yonsei Pediatrics Clinic
Seoul, Korea, Republic of, 134-734
Sponsors and Collaborators
Novartis Vaccines
  More Information

Additional Information:
Responsible Party: Novartis Vaccines
ClinicalTrials.gov Identifier: NCT01404962     History of Changes
Other Study ID Numbers: V37_11
First Submitted: July 25, 2011
First Posted: July 28, 2011
Last Update Posted: December 1, 2016
Last Verified: September 2012

Keywords provided by Novartis ( Novartis Vaccines ):
Haemophilus influenza type b
children
Korea
vaccine
Prevention of haemophilus influenza type b

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs