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Safety, Immune Lot-to-Lot Consistency and Non-Inferiority of Shan 5 (DTwP-HepB-Hib) Vaccine in Comparison to Pentavac SD When Administered as a Single Booster Dose at 15-18 months and Three Doses at 6-8, 10-12 and 14-16 Weeks of Age in Healthy Indian Children and Infants.

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Trial Profile

Safety, Immune Lot-to-Lot Consistency and Non-Inferiority of Shan 5 (DTwP-HepB-Hib) Vaccine in Comparison to Pentavac SD When Administered as a Single Booster Dose at 15-18 months and Three Doses at 6-8, 10-12 and 14-16 Weeks of Age in Healthy Indian Children and Infants.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Nov 2019

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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

    • 05 Mar 2016 Status changed from active, no longer recruiting to completed, as per an abstract presented at the 17th International Congress on Infectious Diseases.
    • 05 Mar 2016 Primary endpoint has been met. (Seroprotection rate), as per an abstract presented at the 17th International Congress on Infectious Diseases.
    • 05 Mar 2016 Results presented at the 17th International Congress on Infectious Diseases
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