Efficacy, Immunogenicity and Safety of a Human Rotavirus Vaccine RIX4414 in Singaporean Infants.
Ann Acad Med Singap
; 45(2): 44-50, 2016 Feb.
Article
en En
| MEDLINE
| ID: mdl-27125345
ABSTRACT
INTRODUCTION:
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. MATERIALS ANDMETHODS:
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.RESULTS:
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.CONCLUSION:
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.
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Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Infecciones por Rotavirus
/
Vacunas contra Rotavirus
/
Inmunogenicidad Vacunal
/
Gastroenteritis
Tipo de estudio:
Clinical_trials
Límite:
Female
/
Humans
/
Infant
/
Male
País/Región como asunto:
Asia
Idioma:
En
Revista:
Ann Acad Med Singap
Año:
2016
Tipo del documento:
Article
País de afiliación:
Singapur