Dr Guillermo Ruiz Palacios and colleagues tested the safety and efficacy of an attenuated G1P human rotavirus vaccine.
The research team conducted a randomized, double-blind, phase 3 trial.
The team studied 63,225 healthy infants from 11 Latin American countries and Finland.
The patients received 2 oral doses of either the human rotavirus vaccine or placebo at approximately 2 months and 4 months of age.
The researchers identified severe gastroenteritis episodes by active surveillance.
| Efficacy reached 100% against more severe rotavirus gastroenteritis|
|New England Journal of Medicine|
The severity of disease was graded with the use of the 20-point Vesikari scale.
Vaccine efficacy was evaluated in a subgroup of 20,169 infants, of which 10,159 were vaccinees and 10,010 were placebo recipients.
The researchers found that the efficacy of the vaccine against severe rotavirus gastroenteritis and rotavirus-associated hospitalization was 85%.
Efficacy reached 100% against more severe rotavirus gastroenteritis.
The team noted that hospitalization for diarrhea of any cause was reduced by 42%.
During the 31-day window after each dose, 6 vaccine recipients and 7 placebo recipients had definite intussusception.
Dr Ruiz Palacios' team concluded, “The 2 oral doses of the live attenuated G1P human rotavirus vaccine were highly efficacious.”
“It protects infants against severe rotavirus gastroenteritis.”
“The vaccine also significantly reduced the rate of severe gastroenteritis from any cause, and was not associated with an increased risk of intussusception.”