Status:
UNKNOWN
Post-authorization Safety Study of Euforvac-Hib Vaccine for Active Primary Immunization in Infants From 6 Weeks
Lead Sponsor:
LG Life Sciences
Conditions:
Diphtheria
Tetanus
Eligibility:
All Genders
6+ years
Brief Summary
A multicenter, observational study to evaluate the safety of Euforvac-Hib vaccine for active primary immunization against diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenza type B i...
Detailed Description
Euforvac-Hib vaccine manufactured by LG Life science in Korea, but it's not marketed in Korea. It is distributed to UN agencies in diverse countries. Thus, WHO recommended LG Life Science to conduct t...
Eligibility Criteria
Inclusion
- Patients who had been signed informed consent by subjects legally acceptable Representative
- Infant from 6 weeks of age.who is given this vaccine for active primary immunization against diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenza type B
Exclusion
- Patients with hypersensitivity to any component for the vaccine
- Patients who had a severe reaction to a previous dose of the combination vaccine or any of its constituents is absolute contraindication to subsequent doses of the combination vaccine.
- Patients who had pertussis, encephalopathy or other serious neurological abnormality in the newborn period
Key Trial Info
Start Date :
March 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2016
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT02257645
Start Date
March 1 2015
End Date
September 1 2016
Last Update
October 7 2014
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