Rotavirus is a leading cause of childhood gastroenteritis and death worldwide.
Dr Timo Vesikari and colleagues studied healthy infants approximately 6 to 12 weeks old.
The investigative team included 34,035 infants in the vaccine group and 34,003 in the placebo group.
The infants were randomized to 3 oral doses of live pentavalent human-bovine (WC3 strain) reassortant rotavirus vaccine or placebo in a blinded fashion.
The investigators administered the vaccine and placebo at 4- to 10-week intervals.
The vaccine contained human serotypes G1, G2, G3, G4, and P.
| Efficacy against severe gastroenteritis was 98%|
|New England Journal of Medicine|
The investigators used active surveillance to identify subjects with serious adverse and other events.
Intussusception occurred in 12 vaccine recipients and 15 placebo recipients within 1 year after the first dose.
This included 6 vaccine recipients and 5 placebo recipients within 42 days after any dose.
The team found that the vaccine reduced hospitalizations related to G1 to G4 rotavirus gastroenteritis occurring 14 or more days after the final dose by 95%.
The vaccine also reduced emergency department visits related to G1 to G4 rotavirus gastroenteritis occurring 14 or more days after the third dose by 95%.
In a nested substudy, the team observed 74% efficacy against any G1 to G4 rotavirus gastroenteritis through the first full rotavirus season after vaccination.
Efficacy against severe gastroenteritis was 98% .
In addition, the investigators observed that the vaccine reduced clinic visits for G1 to G4 rotavirus gastroenteritis by 86%.
Dr Vesikari's team concludes, “This vaccine was efficacious in preventing rotavirus gastroenteritis, decreasing severe disease and health care contacts.”
“The risk of intussusception was similar in vaccine and placebo recipients.”