A Phase-III, Single Arm, Multi-Center, Open-Label Study to Assess the Immunogenicity, Safety and Tolerability of a Fully Liquid Pentavalent Vaccine (DTwP-Hib-HepB Vaccine) When Administered to Indian Infants at 6, 10, and 14 Weeks of Age.

Trial Profile

A Phase-III, Single Arm, Multi-Center, Open-Label Study to Assess the Immunogenicity, Safety and Tolerability of a Fully Liquid Pentavalent Vaccine (DTwP-Hib-HepB Vaccine) When Administered to Indian Infants at 6, 10, and 14 Weeks of Age.

Completed
Phase of Trial: Phase III

Latest Information Update: 20 May 2017

At a glance

  • Drugs Hib-DTP-hepatitis B vaccine (Primary)
  • Indications Diphtheria; Haemophilus infections; Hepatitis B; Pertussis; Tetanus
  • Focus Pharmacodynamics
  • Most Recent Events

    • 15 Feb 2012 Actual initiation date changed from 1 Dec 2011 to 15 Nov 2011 as reported by as reported by Clinical Trials Registry - India.
    • 15 Feb 2012 Status changed from recruiting to completed as reported by Clinical Trials Registry - India.
    • 02 Dec 2011 Actual initiation date (Dec 2011) added as reported by ClinicalTrials.gov.
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