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A phase IIIb, double-blind, randomized, placebo-controlled, multi-country and multi-center study to assess the efficacy, safety and immunogenicity of two doses of GSK Biologicals’ oral live attenuated...

Mise à jour : Il y a 4 ans
Référence : EUCTR2004-001175-19

A phase IIIb, double-blind, randomized, placebo-controlled, multi-country and multi-center study to assess the efficacy, safety and immunogenicity of two doses of GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine in healthy infants in co-administration with specific childhood vaccines

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Extrait

To determine the efficacy of two doses of GSK Biologicals’ HRV vaccine given concomitantly with specific childhood vaccinations against any RV GE caused by the circulating wild-type RV strains during the first efficacy follow-up period.

Critère d'inclusion

  • Two-dose immunization according to 0, 1 or 2-month schedule (in Czech Republic: 0 and 1-month schedule) against rotavirus disease in healthy infants aged 6 to 14 weeks at the time of the first dose. Rotavirus infection

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