# Safety and Immunogenicity Study of the Tetravalent Rotavirus Vaccine

> **NCT01061658** · PHASE1,PHASE2 · UNKNOWN · sponsor: **Shantha Biotechnics Limited** · enrollment: 90 (estimated)

## Conditions studied

- Rotavirus Gastroenteritis

## Interventions

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

## Key facts

- **NCT ID:** NCT01061658
- **Lead sponsor:** Shantha Biotechnics Limited
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1,PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** UNKNOWN
- **Start date:** 2010-07
- **Primary completion:** 2010-11
- **Final completion:** 2010-12
- **Target enrollment:** 90 (ESTIMATED)
- **Last updated:** 2010-10-04


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01061658

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01061658, "Safety and Immunogenicity Study of the Tetravalent Rotavirus Vaccine". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT01061658. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*
