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Phase III Safety and Immunogenicity of an Investigational versus the Licensed Formulation of the Pentavalent Vaccine (DTwP-HepB-Hib) SHAN 5® when administered as Three Dose Primary Series at 6-8, 10-12 and 14-16 Weeks of Age in Healthy Indian Infants and Safety and Immunogenicity of the Investigational SHAN 5® Formulation when administered as a Single Booster Dose at 12-24 Months of Age

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Trial Profile

Phase III Safety and Immunogenicity of an Investigational versus the Licensed Formulation of the Pentavalent Vaccine (DTwP-HepB-Hib) SHAN 5® when administered as Three Dose Primary Series at 6-8, 10-12 and 14-16 Weeks of Age in Healthy Indian Infants and Safety and Immunogenicity of the Investigational SHAN 5® Formulation when administered as a Single Booster Dose at 12-24 Months of Age

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 21 Jan 2020

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At a glance

  • Drugs Hib-DTP-hepatitis B vaccine (Primary)
  • Indications Diphtheria; Haemophilus infections; Hepatitis B; Pertussis; Tetanus
  • Focus Pharmacodynamics; Registrational
  • Sponsors Shantha Biotechnics

Most Recent Events

  • 10 Jan 2020 Status changed from recruiting to active, no longer recruiting.
  • 26 Mar 2019 Status changed from not yet recruiting to recruiting.
  • 26 Mar 2019 New trial record

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