# A Clinical Trial to Study the Effect and Safety of Rotavirus Vaccine Against Severe Rotavirus Gastroenteritis in Healthy Indian Infants

> **NCT02133690** · PHASE3 · COMPLETED · sponsor: **Serum Institute of India Pvt. Ltd.** · enrollment: 7500 (actual)

## Conditions studied

- Rotavirus Gastroenteritis

## Interventions

- **BIOLOGICAL:** Live Attenuated Pentavalent (G1-G2-G3-G4-G9) Human X Bovine Reassortant Rotavirus Vaccine (BRV-PV)
- **OTHER:** Placebo

## Key facts

- **NCT ID:** NCT02133690
- **Lead sponsor:** Serum Institute of India Pvt. Ltd.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2014-05
- **Primary completion:** 2016-03
- **Final completion:** 2017-03
- **Target enrollment:** 7500 (ACTUAL)
- **Last updated:** 2018-09-10

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT02133690

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT02133690, "A Clinical Trial to Study the Effect and Safety of Rotavirus Vaccine Against Severe Rotavirus Gastroenteritis in Healthy Indian Infants". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT02133690. Licensed CC0.

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