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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 )
July 25, 2011
July 28, 2011
December 1, 2016
August 2011
July 2012   (Final data collection date for primary outcome measure)
Number of participants with Adverse Events 28 days following vaccination [ Time Frame: 29 days to 5 months ]
Same as current
Complete list of historical versions of study NCT01404962 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety of Haemophilus Influenza Type b Vaccine When Administered to Korean Children
A Post Marketing Surveillance Study to Monitor the Reactogenicity and Safety of Vaxem™Hib When Administered According to the Prescribing Information in Korea
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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Haemophilus Influenzae Type B Infection
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.
Group 1
Intervention: Biological: Haemophilus influenza type b conjugate vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
764
July 2012
July 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
2 Months to 5 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01404962
V37_11
Not Provided
Not Provided
Not Provided
Novartis ( Novartis Vaccines )
Novartis Vaccines
Not Provided
Not Provided
Novartis
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP