Trial intelligence / Profile preview

Rotarix post-marketing safety surveillance in Indian infants

2017-000451-14Phase 4

Sponsor
GSK
Start
Jun 2017
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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