# A Phase III Clinical Trial to Evaluate the Protective Efficacy of Three Doses of Oral Rotavirus Vaccine (ORV) 116E

> **NCT01305109** · PHASE3 · UNKNOWN · sponsor: **Bharat Biotech International Limited** · enrollment: 6800 (estimated)

## Conditions studied

- Viral Gastroenteritis Due to Rotavirus

## Interventions

- **BIOLOGICAL:** ORV 116E
- **BIOLOGICAL:** Placebo

## Key facts

- **NCT ID:** NCT01305109
- **Lead sponsor:** Bharat Biotech International Limited
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** UNKNOWN
- **Start date:** 2011-03
- **Primary completion:** 2013-12
- **Final completion:** 2014-04
- **Target enrollment:** 6800 (ESTIMATED)
- **Last updated:** 2012-06-12

## Collaborators

- [object Object]
- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01305109

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01305109, "A Phase III Clinical Trial to Evaluate the Protective Efficacy of Three Doses of Oral Rotavirus Vaccine (ORV) 116E". Retrieved via AI Analytics 2026-06-04 from https://api.ai-analytics.org/clinical/NCT01305109. Licensed CC0.

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