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Post-authorization Safety Study of Euforvac-Hib Vaccine for Active Primary Immunization in Infants From 6 Weeks

Hepatitis B Clinical Trial

Official title:
A Multicenter, Post-authorization Safety Study of Euforvac-Hib Vaccine for Active Primary Immunization Against Diphtheria, Tetanus, Pertussis, Hepatitis B and Haemophilus Influenza Type B in Infants

Clinical Trial 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 in infants.

Clinical Trial 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 the safety study for assessing the vaccine safety if Euforvac-Hib is prequalified.

The objectives of this safety study are to identify any problems and questionable issues likely to emerge from the actual use of Euforvac-Hib vaccine after launching in the market. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02257645
Study type Observational
Source LG Life Sciences
Contact Hyejin Yoon
Phone 82-2-6924-3148
Email hyejin0611@lgls.com
Status Not yet recruiting
Phase N/A
Start date March 2015
Completion date September 2016
View Details
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