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HRV vaccine immunogenicity and heat stability in healthy infants
NCT00169455Phase 3
Key facts
- Status
- Completed
- Start
- Mar 2005
- Primary completion
- Dec 2005
- Countries
- 1
- Sponsor
- GSK
- Modality
- Live Attenuated Vaccines
- Conditions
- rotavirus gastroenteritis
01
Overview
Phase 3, randomised, single-blind trial of human rotavirus RIX4414 strain vaccine in rotavirus gastroenteritis, sponsored by GSK. Primary endpoint: Percentage of subjects with vaccine take. Started Mar 2005; status: completed.
02
Design
- Study design
- RandomizedSingle-blind
03
Who it enrols
Healthy infants aged 6-12 weeks, previously uninfected with rotavirus, without chronic GI disease or immunodeficiency.
04
Endpoints
Primary
Percentage of subjects with vaccine take
Secondary
Percentage of subjects who seroconverted
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