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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01404962
First received: July 25, 2011
Last updated: September 10, 2012
Last verified: September 2012
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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:

Primary Outcome Measures:
  • Number of participants with Adverse Events 28 days following vaccination [ Time Frame: 29 days to 5 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   2 Months to 5 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Hanil General Hospital
Seoul, Korea, Republic of, 132-703
KyungHee University Hospital
Seoul, Korea, Republic of, 130-702
Yonsei Pediatrics Clinic
Seoul, Korea, Republic of, 134-734
Sponsors and Collaborators
Novartis Vaccines
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01404962     History of Changes
Other Study ID Numbers: V37_11
Study First Received: July 25, 2011
Last Updated: September 10, 2012
Health Authority: Korea: Food and Drug Administration

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

Additional relevant MeSH terms:
Haemophilus Infections
Influenza, Human
Pasteurellaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 20, 2014