A comparison of safety, tolerability and immunogenicity of Oka/Merck varicella vaccine and VARILRIX in healthy children.
This study compared safety, tolerability, and immunogenicity of the Oka/Merck varicella vaccine and VARILRIX [Oka-RIT strain SmithKline Beecham Biologicals] in healthy children 12-24 months of age. Subjects were randomized in this double blind study to receive either a single dose of Oka/Merck varicella vaccine, (approximately 50,000 plaque forming units (PFU), Group A or approximately 16,000 PFU, Group B) or 1 dose of VARILRIX, (approximately 40,000 PFU/dose, Group C). Safety profiles in each treatment group were similar. The proportions of subjects achieving a 6-week postvaccination titer> or = 5 gpELISA units in Groups A, B or C were 97.1, 95.2 and 85.6%, respectively.
Lau
Yu-Lung
YL
Queen Mary Hospital, Pokfulum, Hong Kong, PR China.
Vessey
S J Rupert
SJ
Chan
Ivan S F
IS
Lee
Tsz-Leung
TL
Huang
Li-Min
LM
Lee
Chin-Yun
CY
Lin
Tzou-Yien
TY
Lee
Bee Wah
BW
Kwan
Kow
K
Kasim
Siti M
SM
Chan
Christina Y
CY
Kaplan
Karen M
KM
Distefano
Daniel J
DJ
Harmon
Anna L
AL
Golie
Amy
A
Hartzel
Jonathan
J
Xu
Jin
J
Li
Shu
S
Matthews
Holly
H
Sadoff
Jerald C
JC
Shaw
Alan
A
D000914:Antibodies, Viral / Q000097:blood; D019433:Chickenpox Vaccine / Q000009:adverse effects* / Q000276:immunology; D004311:Double-Blind Method; D004361:Drug Tolerance; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D014645:Herpesvirus 3, Human / Q000276:immunology; D006801:Humans; D007223:Infant; D008297:Male; D012449:Safety; D014613:Vaccines, Attenuated / Q000009:adverse effects / Q000276:immunology
D000914:Antibodies, Viral; D019433:Chickenpox Vaccine; D014613:Vaccines, Attenuated