NCT01349283

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

A Prospective, Randomized, Double-blind, Parallel-group, Controlled Study of the Immunogenicity and Safety of the Recombinant Hepatitis B Vaccine (Hepavax-Gene TF) and a Comparator Univalent Hepatitis B Vaccine in Neonates

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,738 (actual)
• Sponsor: Crucell Holland BV · Industry
• Sex: All
• Age: 1 Day
• Healthy volunteers: Accepted

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.

Conditions

• Hepatitis B

Interventions

Type	Name	Description
BIOLOGICAL	HepavaxGene (thiomersal free)	10 µg/0.5 mL, intramuscular injection on Day 1, Month 1, Month 6
BIOLOGICAL	Engerix B	10 µg/0.5 mL, intramuscular injection on Day 1, Month 1, Month 6

Timeline

• Start date: 2011-05-01
• Primary completion: 2012-11-01
• Completion: 2013-11-01
• First posted: 2011-05-06
• Last updated: 2014-03-04

Locations

1 site across 1 country: China