Professor Vesikari and colleagues from Germany assessed the efficacy of the oral live attenuated human rotavirus vaccine Rotarix for prevention of rotavirus gastroenteritis.
The team randomized 3,994 European infants during their first 2 years of life from 6 countries to treatment.
Group 1 included 2646 infants randomly assigned to 2 oral doses of Rotarix 4414.
Group 2 included 1348 infants receiving placebo.
The treatments were coadministered with the first 2 doses of specific childhood vaccinations.
|Vaccine efficacy was 96% for admission owing to rotavirus gastroenteritis,|
Follow-up for gastroenteritis episodes was undertaken from 2 weeks post-dose 2 through the 2 consecutive rotavirus seasons following vaccination.
The team's primary endpoint was vaccine efficacy against rotavirus gastroenteritis of any severity during the first efficacy follow-up period.
Stool specimens obtained during gastroenteritis episodes were tested for rotavirus by ELISA.
Episodes scoring 11 or greater on the 20-point Vesikari scale were classified as severe.
Analysis was according to protocol.
The team excluded 120 infants from the according-to-protocol analysis.
During the first efficacy follow-up period, 24 of 2572 infants allocated to Rotarix 4414 had rotavirus gastroenteritis of any severity.
The research team noted that 94 of 1302 given placebo had rotavirus gastroenteritis episodes of any severity.
The researchers observed a vaccine efficacy of 87%.
The team found for the combined efficacy follow-up period, vaccine efficacy against severe rotavirus gastroenteritis was 90%.
The team noted that vaccine efficacy was 96% for admission owing to rotavirus gastroenteritis, and 84% for rotavirus-related medical attention.
Significant protection against severe rotavirus gastroenteritis by circulating G1, G2, G3, G4, and G9 rotavirus types was shown.
Professor Vesikari's team concluded, "In a European setting, 2 doses of Rotarix 4414 coadministered with childhood vaccines provided high protection against any and severe rotavirus gastroenteritis".
"There was an overall reduction of admissions for gastroenteritis over 2 consecutive rotavirus epidemic seasons."