# Safety Study of 2 Formulations of GSK's Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks

> **NCT03954743** · PHASE3 · COMPLETED · sponsor: **GlaxoSmithKline** · enrollment: 1351 (actual)

## Conditions studied

- Infections, Rotavirus

## Interventions

- **BIOLOGICAL:** PCV-free liquid formulation of GSK's oral live attenuated HRV vaccine
- **BIOLOGICAL:** Lyophilized formulation of GSK's oral live attenuated HRV vaccine

## Key facts

- **NCT ID:** NCT03954743
- **Lead sponsor:** GlaxoSmithKline
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2019-07-19
- **Primary completion:** 2020-11-30
- **Final completion:** 2020-11-30
- **Target enrollment:** 1351 (ACTUAL)
- **Last updated:** 2022-03-10


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03954743

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03954743, "Safety Study of 2 Formulations of GSK's Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT03954743. Licensed CC0.

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