These virus types are responsible for more than 98% of gastroenteritis disease in Europe during the first two years of life.
Results from this multi-center, randomized, double-blind, placebo-controlled Phase III trial involving nearly 4,000 infants indicate that two doses of Rotarix provide broad and sustained protection through two consecutive rotavirus seasons (early December through to late May in Europe).
The vaccine was given concomitantly with other routine primary childhood vaccines. Vaccine efficacy during this follow-up period was 90% against severe rotavirus gastroenteritis and 96% against rotavirus hospitalizations irrespective of the rotavirus type.
Thomas Breuer, head of clinical R&D and chief medical officer at GSK Biologicals, said: “The vaccine’s efficacy against the rotavirus G2 (G2P) type described in The Lancet publication is scientifically very important, as it demonstrates for the first time within a single controlled study cross-protection against a non-vaccine strain (fully heterotypic protection).”