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

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

Completed
Phase of Trial: Phase III

Latest Information Update: 06 Oct 2016

At a glance

  • Drugs Hepatitis B vaccine recombinant (Primary)
  • Indications Hepatitis B
  • Focus Pharmacodynamics; Registrational; Therapeutic Use
  • Sponsors Crucell
  • Most Recent Events

    • 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.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top