Trial record 11 of 163 for:    "Haemophilus influenzae"

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
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 April 17, 2014