A Phase III Bridging study to evaluate Immunogenicity and Safety of a Pentavalent vaccine (DTwP-HepB-Hib) Shan5 (with Shantha pertussis) as compared to the licensed vaccine, Shan5 (with imported pertussis) when administered as three dose primary series at 6-8, 10-12 and 14-16 Weeks of Age in Healthy Indian Infants.

Trial Profile

A Phase III Bridging study to evaluate Immunogenicity and Safety of a Pentavalent vaccine (DTwP-HepB-Hib) Shan5 (with Shantha pertussis) as compared to the licensed vaccine, Shan5 (with imported pertussis) when administered as three dose primary series at 6-8, 10-12 and 14-16 Weeks of Age in Healthy Indian Infants.

Completed
Phase of Trial: Phase III

Latest Information Update: 16 Nov 2016

At a glance

  • Drugs Hib-DTP-hepatitis B vaccine (Primary)
  • Indications Diphtheria; Haemophilus infections; Hepatitis B; Pertussis; Tetanus
  • Focus Therapeutic Use
  • Sponsors Shantha Biotechnics
  • Most Recent Events

    • 07 Nov 2016 Status changed from active, no longer recruiting to completed.
    • 01 Sep 2016 New trial record
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