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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

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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

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At a glance

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.

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