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

Tracking Information
First Submitted Date ICMJE	July 25, 2011
First Posted Date ICMJE	July 28, 2011
Last Update Posted Date	December 1, 2016
Study Start Date ICMJE	August 2011
Actual 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 ]
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; Intervention Model: Single Group Assignment; Masking: None (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 Arms	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
Actual Enrollment ICMJE; (submitted: September 10, 2012)	764
Original Estimated Enrollment ICMJE; (submitted: July 27, 2011)	750
Actual Study Completion Date	July 2012
Actual 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
Sex/Gender	Sexes Eligible for Study: All
Ages	2 Months to 5 Years (Child)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Korea, Republic of
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01404962
Other Study ID Numbers ICMJE	V37_11
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Novartis ( Novartis Vaccines )
Study Sponsor ICMJE	Novartis Vaccines
Collaborators ICMJE	Not Provided
Investigators ICMJE	Not Provided
PRS Account	Novartis
Verification Date	September 2012
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP