Safety and efficacy of human rotavirus vaccine during the first 2 years of life in Asian infants: randomised, double-blind, controlled study.
This study evaluates the safety and efficacy against severe rotavirus gastroenteritis of the oral live attenuated human rotavirus vaccine RIX4414 (Rotarix) during the first 2 years of life in Asian infants from high-income countries. Healthy infants were enrolled to receive 2 doses of RIX4414 (N=5,359) or placebo (N=5,349). From 2 weeks post-dose 2 to 2 years of age, vaccine efficacy was 96.1% (95%CI:85.1%; 99.5%) against severe rotavirus gastroenteritis, 100% (95%CI:80.8%; 100%) against wild-type G1P[8] and 93.6% (95%CI:74.7%; 99.3%) against circulating non-G1 rotavirus types. No intussusception cases were reported within 31 days post-vaccination. RIX4414 shows a good safety profile and offers high protection during the first 2 years of life with potentially significant public health impact in this population.
Phua
K B
KB
Department of Paediatrics, KK Women's and Children's Hospital, 100 Bukit, Timah Road, Singapore 229899, Singapore. Phua.Kong.Boo@kkh.com.sg
Lim
F S
FS
Lau
Y L
YL
Nelson
E A S
EA
Huang
L M
LM
Quak
S H
SH
Lee
B W
BW
Teoh
Y L
YL
Tang
H
H
Boudville
I
I
Oostvogels
L C
LC
Suryakiran
P V
PV
Smolenov
I V
IV
Han
H H
HH
Bock
H L
HL
D002675:Child, Preschool; D004311:Double-Blind Method; D005759:Gastroenteritis / Q000517:prevention & control* / Q000821:virology; D006801:Humans; D007223:Infant; D012400:Rotavirus Infections / Q000517:prevention & control*; D022243:Rotavirus Vaccines / Q000008:administration & dosage*; D014613:Vaccines, Attenuated / Q000008:administration & dosage
C492457:RIX4414 vaccine; D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated