Back to resultsSafety of Haemophilus Influenza Type b Vaccine When Administered to Korean Children
Primary Purpose
Haemophilus Influenzae Type B Infection
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Haemophilus influenza type b conjugate vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Haemophilus Influenzae Type B Infection focused on measuring Haemophilus influenza type b, children, Korea, vaccine, Prevention of haemophilus influenza type b
Eligibility Criteria
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
Sites / Locations
- Moon's Pediatrics Clinic
- Wooriai Pediatrics clinic
- KyungHee University Hospital
- Hanil General Hospital
- Yonsei Pediatrics Clinic
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Group 1
Arm Description
Outcomes
Primary Outcome Measures
Number of participants with Adverse Events 28 days following vaccination
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01404962
Brief Title
Safety of Haemophilus Influenza Type b Vaccine When Administered to Korean Children
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 Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Haemophilus Influenzae Type B Infection
Keywords
Haemophilus influenza type b, children, Korea, vaccine, Prevention of haemophilus influenza type b
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
764 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Other
Intervention Type
Biological
Intervention Name(s)
Haemophilus influenza type b conjugate vaccine
Intervention Description
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 Measure Information:
Title
Number of participants with Adverse Events 28 days following vaccination
Time Frame
29 days to 5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Moon's Pediatrics Clinic
City
Gyeonggi-do
ZIP/Postal Code
449-812
Country
Korea, Republic of
Facility Name
Wooriai Pediatrics clinic
City
Incheon
ZIP/Postal Code
407-818
Country
Korea, Republic of
Facility Name
KyungHee University Hospital
City
Seoul
ZIP/Postal Code
130-702
Country
Korea, Republic of
Facility Name
Hanil General Hospital
City
Seoul
ZIP/Postal Code
132-703
Country
Korea, Republic of
Facility Name
Yonsei Pediatrics Clinic
City
Seoul
ZIP/Postal Code
134-734
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Safety of Haemophilus Influenza Type b Vaccine When Administered to Korean Children
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