Safety of Haemophilus Influenza Type b Vaccine When Administered to Korean Children
This study has been completed.
Sponsor:
Novartis Vaccines
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Haemophilus Influenzae Type B Infection |
Biological: Haemophilus influenza type b conjugate vaccine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Flu
Drug Information available for:
Haemophilus Influenzae type b Conjugate Vaccine
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- Number of participants with Adverse Events 28 days following vaccination [ Time Frame: 29 days to 5 months ] [ Designated as safety issue: No ]
| Enrollment: | 764 |
| Study Start Date: | August 2011 |
| Study Completion Date: | July 2012 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Group 1 |
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.
|
Eligibility| Ages Eligible for Study: | 2 Months to 5 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01404962
Locations
| Korea, Republic of | |
| Moon's Pediatrics Clinic | |
| Gyeonggi-do, Korea, Republic of, 449-812 | |
| Wooriai Pediatrics clinic | |
| Incheon, Korea, Republic of, 407-818 | |
| Hanil General Hospital | |
| Seoul, Korea, Republic of, 132-703 | |
| KyungHee University Hospital | |
| Seoul, Korea, Republic of, 130-702 | |
| Yonsei Pediatrics Clinic | |
| Seoul, Korea, Republic of, 134-734 | |
Sponsors and Collaborators
Novartis Vaccines
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Vaccines ) |
| ClinicalTrials.gov Identifier: | NCT01404962 History of Changes |
| Other Study ID Numbers: | V37_11 |
| Study First Received: | July 25, 2011 |
| Last Updated: | September 10, 2012 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Novartis:
|
Haemophilus influenza type b children Korea vaccine Prevention of haemophilus influenza type b |
Additional relevant MeSH terms:
|
Haemophilus Infections Influenza, Human Pasteurellaceae Infections Gram-Negative Bacterial Infections Bacterial Infections |
Orthomyxoviridae Infections RNA Virus Infections Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 16, 2013