Oral live attenuated human rotavirus vaccine (RotarixTM) offers sustained high protection against severe G9P[8] rotavirus gastroenteritis during the first two years of life in Brazilian children
Mem. Inst. Oswaldo Cruz
;
107(7): 846-853, Nov. 2012. ilus, graf, tab
Article
in English
| LILACS
| ID: lil-656038
ABSTRACT
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 11 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% [95% confidence interval (CI) 37.5-89.1%] against severe rotavirus-related gastroenteritis, reaching a protection rate of 81.8% (95% CI 36.4-96.6%) 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.
Full text:
Available
Index:
LILACS (Americas)
Main subject:
Rotavirus Infections
/
Rotavirus Vaccines
/
Gastroenteritis
/
Antibodies, Viral
Type of study:
Controlled clinical trial
Limits:
Child, preschool
/
Female
/
Humans
/
Infant
/
Male
Country/Region as subject:
South America
/
Brazil
Language:
English
Journal:
Mem. Inst. Oswaldo Cruz
Journal subject:
Tropical Medicine
/
Parasitology
Year:
2012
Type:
Article
Affiliation country:
Brazil
/
Netherlands
Institution/Affiliation country:
DDL Diagnostic Laboratory/NL
/
Secretaria de Vigilância em Saúde/BR
/
Universidade Federal do Pará/BR
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