# A Trial to Assess the Safety, Immunogenicity and Efficacy of a Trivalent Rotavirus P2-VP8 Subunit Vaccine in Prevention of Severe Rotavirus Gastroenteritis in Healthy Infants in Africa and India

> **NCT04010448** · PHASE3 · UNKNOWN · sponsor: **PATH** · enrollment: 8200 (estimated)

## Conditions studied

- Rotavirus Infection of Children

## Interventions

- **BIOLOGICAL:** TV P2-VP8
- **BIOLOGICAL:** Rotarix

## Key facts

- **NCT ID:** NCT04010448
- **Lead sponsor:** PATH
- **Sponsor class:** OTHER
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** UNKNOWN
- **Start date:** 2019-10-10
- **Primary completion:** 2025-12-15
- **Final completion:** 2025-12-15
- **Target enrollment:** 8200 (ESTIMATED)
- **Last updated:** 2021-04-09

## Collaborators

- [object Object]
- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04010448

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04010448, "A Trial to Assess the Safety, Immunogenicity and Efficacy of a Trivalent Rotavirus P2-VP8 Subunit Vaccine in Prevention of Severe Rotavirus Gastroenteritis in Healthy Infants in Africa and India". Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/clinical/NCT04010448. Licensed CC0.

---

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