This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines ) Identifier:
First received: July 25, 2011
Last updated: November 30, 2016
Last verified: September 2012
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.


Ages Eligible for Study:   2 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 identifier: NCT01404962

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 Identifier: NCT01404962     History of Changes
Other Study ID Numbers: V37_11
Study First Received: July 25, 2011
Last Updated: November 30, 2016

Keywords provided by Novartis ( Novartis Vaccines ):
Haemophilus influenza type b
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
Immunologic Factors
Physiological Effects of Drugs processed this record on September 21, 2017