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.
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
- 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.