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Clinical trial

A Phase III, Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Protective Efficacy of Three Doses of Oral Rotavirus Vaccine (ORV) 116E, Against Severe Rotavirus Gastroenteritis in Infants

NCT01305109 is registered in ClinicalTrials.gov with Bharat Biotech International Limited as lead sponsor.

NCT NCT01305109
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Registry record

As filed in ClinicalTrials.gov.

Title
A Phase III, Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Protective Efficacy of Three Doses of Oral Rotavirus Vaccine (ORV) 116E, Against Severe Rotavirus Gastroenteritis in Infants
Lead sponsor
Bharat Biotech International Limited
Phase
Phase 3
Overall status
Unknown status
Start date
March 31, 2011
Completion date
April 30, 2014
Enrollment
6,800 (estimated)
Sites
3

Conditions

As the registry lists them; a condition with its own page is linked.

viral gastroenteritis due to rotavirus