# A Study to Evaluate the Safety of Tetravalent Rotavirus Vaccine in Healthy Indian Adult Male Volunteers

> **NCT01091298** · PHASE1 · COMPLETED · sponsor: **Shantha Biotechnics Limited** · enrollment: 20 (estimated)

## Conditions studied

- Rotavirus Gastroenteritis

## Interventions

- **BIOLOGICAL:** Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine (BRV-TV)
- **OTHER:** Placebo

## Key facts

- **NCT ID:** NCT01091298
- **Lead sponsor:** Shantha Biotechnics Limited
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2010-04
- **Primary completion:** 2010-05
- **Final completion:** 2010-05
- **Target enrollment:** 20 (ESTIMATED)
- **Last updated:** 2011-06-08


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01091298

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01091298, "A Study to Evaluate the Safety of Tetravalent Rotavirus Vaccine in Healthy Indian Adult Male Volunteers". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT01091298. Licensed CC0.

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