Safety of Haemophilus Influenza Type b Vaccine When Administered to Korean Children
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ClinicalTrials.gov Identifier: NCT01404962 |
Recruitment Status
:
Completed
First Posted
: July 28, 2011
Last Update Posted
: December 1, 2016
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Sponsor:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
Tracking Information | |||
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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 |
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 |
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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. |
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Study Arms | Group 1
Intervention: Biological: Haemophilus influenza type b conjugate vaccine |
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Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
764 | ||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |