A short report on highlights of worldwide development of RIX4414: a Singaporean experience.
In Singapore, we conducted a phase II randomized, double-blind, placebo-controlled dose ranging study using an attenuated human rotavirus vaccine, RIX4414. Altogether, 2464 healthy infants were recruited. Two oral doses of vaccine at 104.7, 105.2 or 106.1 ffu or placebo were administered with routine immunizations at 3 and 4 months of age. Seroconversion and 'vaccine take' in the vaccine groups 1-month post dose 2 varied from 76 to 91% and 98 to 100% respectively. Vaccine was well tolerated and did not interfere with response of concomitantly administered vaccines.
Phua
K B
KB
Department of Pediatrics, KK Women's and Children's Hospital, 100 Bukit Timah Road, Singapore 229899, Singapore. kbphua@kkh.com.sg
Quak
S H
SH
Emmanuel
S
S
Goh
P S C
PS
Han
H H
HH
Hardt
K
K
Bock
H L
HL
De Vos
B
B
D000914:Antibodies, Viral / Q000097:blood; D004311:Double-Blind Method; D006801:Humans; D007223:Infant; D012401:Rotavirus / Q000276:immunology; D022243:Rotavirus Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D012846:Singapore; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
D000914:Antibodies, Viral; C492457:RIX4414 vaccine; D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated