Double-Blind Randomized Placebo-Controlled Dose Escalating Phase Ib/IIa Study to Evaluate the Safety and Immunogenicity of Live Attenuated Oral Rotavirus Vaccine 116E in Healthy Non-Malnourished Infants 8 to 20 Weeks of Age.

Trial Profile

Double-Blind Randomized Placebo-Controlled Dose Escalating Phase Ib/IIa Study to Evaluate the Safety and Immunogenicity of Live Attenuated Oral Rotavirus Vaccine 116E in Healthy Non-Malnourished Infants 8 to 20 Weeks of Age.

Completed
Phase of Trial: Phase I/II

Latest Information Update: 30 May 2014

At a glance

  • Drugs ORV 116E (Primary)
  • Indications Rotavirus infections
  • Focus Adverse reactions; Pharmacodynamics
  • Sponsors Bharat Biotech
  • Most Recent Events

    • 30 Sep 2009 Actual end date (15 Feb 2008) added as reported by ISRCTN: Current Controlled Trials record.
    • 30 Sep 2009 New source identified and integrated (ISRCTN: Current Controlled Trials, 57452882).
    • 30 Sep 2009 Status changed from active, no longer recruiting to completed as reported by ISRCTN: Current Controlled Trials record.
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