Trial Profile
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 of Trial:
Phase III
Latest Information Update: 24 Nov 2016
Price :
$35
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At a glance
- Drugs Hepatitis B vaccine recombinant (Primary)
- Indications Hepatitis B
- Focus Pharmacodynamics; Registrational; Therapeutic Use
- Sponsors Crucell
- 06 Oct 2016 Primary endpoint (Positivity for HBsAg for subjects in Stratum 1-Efficacy) has been met, according to results published in the Pediatric Infectious Disease Journal.
- 06 Oct 2016 Primary endpoint (Seroprotection rate for subjects in Stratum 2-Immunogenicity) has been met, according to results published in the Pediatric Infectious Disease Journal.
- 06 Oct 2016 Results of this study, published in the Pediatric Infectious Disease Journal.