Efficacy of the human rotavirus vaccine RIX4414 in malnourished children.

Authors :: Perez-Schael I
Salinas B
Tomat M
Linhares AC
Guerrero ML
Ruiz-Palacios GM
Bouckenooghe A
Yarzabal JP
Source :: The Journal of infectious diseases [J Infect Dis] 2007 Aug 15; Vol. 196 (4), pp. 537-40. Date of Electronic Publication: 2007 Jun 29.
Publication Year :: 2007
Abstract: Unlabelled: The effect of nutritional status on protective efficacy of a live attenuated human rotavirus vaccine (RIX4414) was studied. Vaccine protection was evaluated through a secondary analysis of data from an efficacy study conducted in Brazil, Mexico, and Venezuela. Vaccine efficacy against rotavirus gastroenteritis (RVGE) was similar in well-nourished and malnourished infants: 74.1% (95% confidence interval [CI], 52.2%-86.2%) and 73% (95% CI, 11.2%-92.3%) for severe RVGE and 60.9% (95% CI, 37.4%-75.4%) and 61.2% (95% CI, 10.4%-83.1%) for RVGE of any severity, respectively. RIX4414 significantly decreased the rate of RVGE regardless of nutritional status, which suggests that this patient group can also benefit from rotavirus vaccination.<br />Clinical Trials Registry: e-Track 444563-006, NCT00385320 (http://www.clinicaltrials.gov).