# To Assess Safety, Reactogenicity & Immunogenicity of 2 Doses of GSK's Oral Human Rotavirus Vaccine in Pre-Term Infants

> **NCT00420745** · PHASE3 · COMPLETED · sponsor: **GlaxoSmithKline** · enrollment: 1009 (actual)

## Conditions studied

- Infections, Rotavirus

## Interventions

- **BIOLOGICAL:** Rotarix™
- **BIOLOGICAL:** Placebo

## Key facts

- **NCT ID:** NCT00420745
- **Lead sponsor:** GlaxoSmithKline
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2007-01-25
- **Primary completion:** 2008-03-01
- **Final completion:** 2008-03-25
- **Target enrollment:** 1009 (ACTUAL)
- **Last updated:** 2018-06-08


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00420745

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00420745, "To Assess Safety, Reactogenicity & Immunogenicity of 2 Doses of GSK's Oral Human Rotavirus Vaccine in Pre-Term Infants". Retrieved via AI Analytics 2026-06-01 from https://api.ai-analytics.org/clinical/NCT00420745. Licensed CC0.

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