Oral live attenuated rotavirus vaccine (RotarixTM) offers a sustained high protection against severe G9P[8] rotavirus gastroenteritis during the first two years of life in Brazilian children

In a large Phase III trial conducted in 10 Latin American countries, the safety and efficacy of the live attenuated monovalent rotavirus vaccine RIX4414 was evaluated in 15,183 healthy infants followed up during the first two years of life. Belém was the only site in Brazil included in this multicen...

Full description

Bibliographic Details
Authors: Justino, Maria Cleonice Aguiar, Araújo, Eliete da Cunha, Doorn, Leen-Jan Van, Oliveira, Consuelo Silva de, Gabbay, Yvone Benchimol, Mascarenhas, Joana D'Arc Pereira, Miranda, Yllen S, Guerra, Sylvia de Fátima dos Santos, Silva, Veronilce B da, Linhares, Alexandre da Costa
Format: article
Status:Published version
Publication Date:2012
Country:Brasil
Institution:Instituto Evandro Chagas (IEC)
Repository:Repositório Digital do Instituto Evandro Chagas (Patuá)
Language:English
OAI Identifier:oai:patua.iec.gov.br:iec/3271
Online Access:https://patua.iec.gov.br/handle/iec/3271
Access Level:Open access
Keyword:Rotavirus
Vacinas contra Rotavirus / isolamento & purificação
Gastroenterite
Description
Summary:In a large Phase III trial conducted in 10 Latin American countries, the safety and efficacy of the live attenuated monovalent rotavirus vaccine RIX4414 was evaluated in 15,183 healthy infants followed up during the first two years of life. Belém was the only site in Brazil included in this multicentre trial. The study in Belém included a subset of 653 infants who were followed up until 24 months of age for protection against severe rotavirus gastroenteritis. These subjects were randomly assigned in a 1:1 ratio to receive two doses of vaccine (n = 328) or two doses of placebo (n = 325) at approximately two and four months of age. Of the 653 enrolled infants, 23 dropped out during the study period. For the combined two-year period, the efficacy of RIX4414 was 72.3 per cent [95 per cent confidence interval (CI) 37.5-89.1per cent] against severe rotavirus-related gastroenteritis, reaching a protection rate of 81.8 per cent (95 per cent CI 36.4-96.6 per cent) against circulating wild-type G9 rotavirus strains. It is concluded that two doses of RIX4414 are highly efficacious against severe rotavirus gastroenteritis in Belém during the first two years of life and provide high protection against the worldwide emergence and spread of G9P[8] strains.

Similar Items