NCT02257645

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (estimated)
• Sponsor: LG Life Sciences · Industry
• Sex: All
• Age: 6 Weeks
• Healthy volunteers: Accepted

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.

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 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.

Conditions

• Diphtheria
• Tetanus
• Pertussis
• Hepatitis B
• Haemophilus Influenza Type B

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-05-01
• Completion: 2016-09-01
• First posted: 2014-10-06
• Last updated: 2014-10-07