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Study to evaluate the efficacy, safety and immunogenicity of two or three doses of GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine given concomitantly with routine EPI vaccinations...

Mise à jour : Il y a 4 ans
Référence : EUCTR2015-001485-26

Study to evaluate the efficacy, safety and immunogenicity of two or three doses of GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine given concomitantly with routine EPI vaccinations in healthy infants

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Extrait

To determine if the GSK Biologicals' HRV vaccine (pooled HRV groups) given concomitantly with routine EPI vaccinations can prevent severe RV GE (>11 on the 20-point Vesikari scoring system) caused by the circulating wild-type RV strains during the period from 2 weeks after the last dose of HRV vaccine or placebo until Visit 6. Criteria: The primary objective will be reached if the lower limit of the 95% CI on vaccine efficacy is >0%.

Critère d'inclusion

  • Healthy Volunteers

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