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

History of Changes

Tracking Information
First Received Date ^ICMJE	July 25, 2011
Last Updated Date	September 10, 2012
Start Date ^ICMJE	August 2011
Primary Completion Date	July 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 27, 2011)	Number of participants with Adverse Events 28 days following vaccination [ Time Frame: 29 days to 5 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01404962 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety of Haemophilus Influenza Type b Vaccine When Administered to Korean Children
Official Title ^ICMJE	A Post Marketing Surveillance Study to Monitor the Reactogenicity and Safety of Vaxem™Hib When Administered According to the Prescribing Information in Korea
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Condition ^ICMJE	Haemophilus Influenzae Type B Infection
Intervention ^ICMJE	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.
Study Arm (s)	Group 1 Intervention: Biological: Haemophilus influenza type b conjugate vaccine
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	764
Completion Date	July 2012
Primary Completion Date	July 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	2 Months to 5 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01404962
Other Study ID Numbers ^ICMJE	V37_11
Has Data Monitoring Committee	Not Provided
Responsible Party	Novartis ( Novartis Vaccines )
Study Sponsor ^ICMJE	Novartis Vaccines
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Novartis
Verification Date	September 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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