# Assess the Immunogenicity of the Human Rotavirus (HRV) Vaccine After Reconstitution Without Buffering Agent; & Evaluate the Immunogenicity, Reactogenicity & Safety of the Vaccine After Storage for 7 d at 37°C Following 2 Doses in Healthy Infants

> **NCT00169455** · PHASE3 · COMPLETED · sponsor: **GlaxoSmithKline** · enrollment: 450 (actual)

## Conditions studied

- Rotavirus Gastroenteritis

## Interventions

- **BIOLOGICAL:** Live attenuated human rotavirus vaccine

## Key facts

- **NCT ID:** NCT00169455
- **Lead sponsor:** GlaxoSmithKline
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2005-03
- **Primary completion:** 2005-12
- **Final completion:** 2005-12
- **Target enrollment:** 450 (ACTUAL)
- **Last updated:** 2017-01-16


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00169455

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00169455, "Assess the Immunogenicity of the Human Rotavirus (HRV) Vaccine After Reconstitution Without Buffering Agent; & Evaluate the Immunogenicity, Reactogenicity & Safety of the Vaccine After Storage for 7 d at 37°C Following 2 Doses in Healthy Infants". Retrieved via AI Analytics 2026-06-01 from https://api.ai-analytics.org/clinical/NCT00169455. Licensed CC0.

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