COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

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. Identifier: NCT01404962
Recruitment Status : Completed
First Posted : July 28, 2011
Last Update Posted : December 1, 2016
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

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.

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 764 participants
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
Study Start Date : August 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
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.

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
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

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 identifier (NCT number): NCT01404962

Layout table for location information
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
Additional Information:
Layout table for additonal information
Responsible Party: Novartis Vaccines Identifier: NCT01404962    
Other Study ID Numbers: V37_11
First Posted: July 28, 2011    Key Record Dates
Last Update Posted: December 1, 2016
Last Verified: September 2012
Keywords provided by Novartis ( Novartis Vaccines ):
Haemophilus influenza type b
Prevention of haemophilus influenza type b
Additional relevant MeSH terms:
Layout table for MeSH terms
Haemophilus Infections
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Pasteurellaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections