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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
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.
Details
| Lead sponsor | Crucell Holland BV |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 1738 |
| Start date | 2011-05 |
| Completion | 2013-11 |
Conditions
- Hepatitis B
Interventions
- HepavaxGene (thiomersal free)
- Engerix B
Primary outcomes
- Seroconversion rate for subjects in Stratum 2 — Month 7
Hepatitis B surface antibody (HBsAb) concentrations are measured from blood samples by standard enzyme linked immuno sorbent assay (ELISA) for subjects whose mothers are negative for chronic hepatitis B. Seroconversion rate is defined as HBsAb ≥10 mIU/mL. - Positivity for HBsAg for subjects in Stratum 1 — Month 2, Month 7 and Month 12
The presence of hepatitis B surface antigen (HBsAg), as determined by ELISA, for subjects whose mothers are positive for chronic hepatitis B
Countries
China