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

July 25, 2011
September 10, 2012
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 ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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
Both
2 Months to 5 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01404962
V37_11
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