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Live Attenuated Human Rotavirus Vaccine, RIX4414, Provides Clinical Protection in Infants Against Rotavirus Strains With and Without Shared G and P Genotypes: Integrated Analysis of Randomized Controlled Trials

De Vos, Beatrice MD*; Han, Htay Htay MD*; Bouckenooghe, Alain MD*; Debrus, Serge PhD*; Gillard, Paul MD*; Ward, Richard PhD; Cheuvart, Brigitte PhD*

The Pediatric Infectious Disease Journal: April 2009 - Volume 28 - Issue 4 - p 261-266
doi: 10.1097/INF.0b013e3181907177
Original Studies

Background: The 2-dose, oral live attenuated human G1P[8] rotavirus vaccine (RIX4414) is highly effective against rotavirus gastroenteritis caused by circulating G1 and non-G1 types. An integrated analysis on vaccine efficacy was undertaken to obtain more precise estimates of the overall protective effect of the RIX4414 vaccine against rotavirus gastroenteritis due to common rotavirus types (G1, G3, G4, G9, P[8]) and less commonly encountered strains such as G2P[4] across heterogenous settings.

Methods: The studies used in the integrated analysis were all previously reported randomized, double-blind, placebo-controlled, phase II and III trials with at least 1 report of rotavirus gastroenteritis in the efficacy follow-up period (up to 1 year of age or end of first RV epidemic season after vaccination). The integrated analysis was performed for all circulating rotavirus strains sharing G and/or P genotype and not sharing G or P genotype with the vaccine strain. Vaccine efficacy was estimated as 1 minus rate of rotavirus gastroenteritis relative to placebo, using exact Poisson rate ratio stratified by study.

Results: The integrated estimates for vaccine efficacy against severe rotavirus gastroenteritis were 87.43% (95% confidence interval [CI]: 78.89–92.86) for G1P[8] strains, 71.42% (95% CI: 20.12–91.11) for G2P[4] strains, 90.19% (95% CI: 55.51–98.94) for G3P[8] strains, 93.37% (95% CI: 51.50–99.85) for G4P[8] strains, and 83.76% (95% CI: 71.18–91.28) for G9P[8] strains. The integrated estimates for vaccine efficacies against rotavirus gastroenteritis of any severity were 82.57% (95% CI: 73.91–88.56) for G1P[8] strains, 81.04% (95% CI: 31.58–95.76) for G2P[4] strains, 87.66% (95% CI: 34.57–98.76) for G3P[8] strains, 84.86% (95% CI: 50.92–96.41) for G4P[8] strains, and 60.64% (95% CI: 38.15–74.96) for G9P[8] strains.

Conclusions: Two doses of RIX4414 provide overall good clinical protection against all cases of rotavirus gastroenteritis and comparable, high clinical protection against severe rotavirus gastroenteritis caused by circulating rotavirus strains with and without G and P genotypes shared with the vaccine strain, such as G2P[4].

From the *GlaxoSmithKline Biologicals, Rixensart, Belgium; and †Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.

Accepted for publication October 7, 2008.

Alain Bouckenooghe is currently at Sanofi Pasteur, Swiftwater, PA. Beatrice De Vos is currently at Sanofi Pasteur, Lyon, France.

All studies were funded by GlaxoSmithKline Biologicals. The sponsor was involved in all study stages from study design to data analysis.

Address for correspondence: Brigitte Cheuvart, PhD, GlaxoSmithKline Biologicals, Rue de l'Institut 89, 1330 Rixensart, Belgium. E-mail: Brigitte.Cheuvart@gskbio.com.

© 2009 Lippincott Williams & Wilkins, Inc.