A rotavirus vaccine for prophylaxis of infants against rotavirus gastroenteritis.
The need for safe and effective vaccines to reduce morbidity and mortality caused by rotavirus gastroenteritis in children is well-known. A live attenuated monovalent rotavirus vaccine (Rotarix) containing human rotavirus strain RIX4414 of G1P1A P[8] specificity is being developed to meet the global need. An overview of RIX4414 trials in developed and developing settings is presented for 3 selected trials conducted in Finland (pilot study), Latin America (Brazil, Mexico and Venezuela) and Singapore involving 5024 infants. The vaccine was well-tolerated, with no increase in any solicited symptoms as compared with the placebo. After 2 doses, 61-91% of vaccinated infants developed rotavirus-specific IgA antibodies. There was no interference with immunogenicity of coadministered routine pediatric vaccines. Rotarix significantly reduced rotavirus gastroenteritis episodes and rotavirus-related hospitalizations in vaccinated infants compared with placebo recipients (P < 0.05). Vaccine efficacy was observed against severe rotavirus gastroenteritis caused by G1 and non-G1 types including the emerging G9 type (P < 0.05) in Latin America. These results show prospects for widespread use of Rotarix to reduce rotavirus disease burden and warrant continued worldwide evaluation.
De Vos
Beatrice
B
GlaxoSmithKline Biologicals, Rixensart, Belgium.
Vesikari
Timo
T
Linhares
Alexandre C
AC
Salinas
Belén
B
Pérez-Schael
Irene
I
Ruiz-Palacios
Guillermo M
GM
Guerrero
Maria de Lourdes
Mde L
Phua
Kong Boo
KB
Delem
Andrée
A
Hardt
Karin
K
D002986:Clinical Trials as Topic; D005759:Gastroenteritis / Q000517:prevention & control* / Q000821:virology*; D006801:Humans; D007223:Infant; D012400:Rotavirus Infections / Q000517:prevention & control*; D022243:Rotavirus Vaccines / Q000276:immunology*
D022243:Rotavirus Vaccines