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Rotarix post-marketing safety and reactogenicity surveillance in Sri Lankan infants
2015-001546-28Phase 4
- Sponsor
- GSK
- Start
- Jun 2015
- Modality
- Vaccines & Immunotherapeutics
- Countries
- 1
01
Overview
Phase 4, open-label, single-arm trial of human rotavirus RIX4414 strain vaccine in rotaviral diarrhea, sponsored by GSK. Primary endpoint: Occurrence of at least one grade 2 or grade 3 fever, vomiting or diarrhoea.
02
Drugs
human rotavirus RIX4414 strain vaccine
03
Conditions
rotaviral diarrhea
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