Immunogenicity and Safety of the Hepatitis B Vaccine Hepavax-Gene TF and a Comparator Hepatitis B Vaccine in Newborns

Summary

The primary purpose of this study is to determine whether HepavaxGene TF is non-inferior to the comparator vaccine both at impeding hepatitis B transmission from mothers positive for chronic hepatitis B (Stratum 1) to their children and also in terms of seroconversion rate in children of mothers negative for chronic hepatitis B (Stratum 2) one month after completion of the immunization schedule.

Timeline

Start

2011-05

Primary completion

2012-11

Completion

2013-11

Publications

• Zhu F, Deckx H, Roten R, Michiels B, Sarnecki M. Comparative Efficacy, Safety and Immunogenicity of Hepavax-Gene TF and Engerix-B Recombinant Hepatitis B Vaccines in Neonates in China. Pediatr Infect Dis J. 2017 Jan;36(1):94-101. doi: 10.1097/INF.0000000000001361.

Drugs

Indications