Efficacy, Immunogenicity and Safety of a Human Rotavirus Vaccine RIX4414 in Singaporean Infants
Annals of the Academy of Medicine, Singapore
;
: 44-50, 2016.
Artículo
en Inglés
| WPRIM
| ID: wpr-309459
ABSTRACT
<p><b>INTRODUCTION</b>This was the first study conducted to evaluate the efficacy of 2 oral doses of the human rotavirus vaccine, RIX4414 in Singaporean infants during the first 3 years of life.</p><p><b>MATERIALS AND METHODS</b>Healthy infants, 11 to 17 weeks of age were enrolled in this randomised (11), double-blinded, placebo-controlled study to receive 2 oral doses of RIX4414 vaccine/placebo following a 0-, 1-month schedule. Vaccine efficacy against severe rotavirus (RV) gastroenteritis (Vesikari score ≥11) caused by wild-type RV strains from a period starting from 2 weeks post-Dose 2 until 2 and 3 years of age was calculated with 95% confidence interval (CI). Immunogenicity and safety of the vaccine were also assessed.</p><p><b>RESULTS</b>Of 6542 infants enrolled, 6466 were included in the efficacy analysis and a subset of 100 infants was included in the immunogenicity analysis. Fewer severe RV gastroenteritis episodes were reported in the RIX4414 group when compared to placebo at both 2 and 3 year follow-up periods. Vaccine efficacy against severe RV gastroenteritis at the respective time points were 93.8% (95% CI, 59.9 to 99.9) and 95.2% (95% CI, 70.5 to 99.9). One to 2 months post-Dose 2 of RIX4414, 97.5% (95% CI, 86.8 to 99.9) of infants seroconverted for anti-RV IgA antibodies. The number of serious adverse events recorded from Dose 1 until 3 years of age was similar in both groups.</p><p><b>CONCLUSION</b>Two oral doses of RIX4414 vaccine was immunogenic and provided high level of protection against severe RV gastroenteritis in Singaporean children, during the first 3 years of life when the disease burden is highest.</p>
Texto completo:
Disponible
Índice:
WPRIM (Pacífico Occidental)
Asunto principal:
Infecciones por Rotavirus
/
Singapur
/
Virología
/
Inmunoglobulina A
/
Vacunas Atenuadas
/
Método Doble Ciego
/
Resultado del Tratamiento
/
Rotavirus
/
Vacunas contra Rotavirus
/
Usos Terapéuticos
Tipo de estudio:
Ensayo Clínico Controlado
Límite:
Femenino
/
Humanos
/
Lactante
/
Masculino
País/Región como asunto:
Asia
Idioma:
Inglés
Revista:
Annals of the Academy of Medicine, Singapore
Año:
2016
Tipo del documento:
Artículo
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