In clinical trials, efficacy was demonstrated against gastro-enteritis due to rotavirus of the most common genotypes G1P [8], G2P [4], G3P [8], G4P [8] and G9P [8]. In addition, efficacy against uncommon rotavirus genotypes G8P [4](severe gastro-enteritis) and G12P [6] (any gastro-enteritis) has been demonstrated. These strains are circulating worldwide. Clinical studies have been conducted in Europe, Latin America, Africa and Asia to evaluate the protective efficacy of rotavirus vaccine against any and severe rotavirus gastro-enteritis.
Not applicable.
Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity.
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