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.

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.

Completed
Phase of Trial: Phase III

Latest Information Update: 24 Aug 2016

At a glance

  • Drugs Hib-DTP-hepatitis B-poliovirus 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
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top