Immunogenicity and safety of a live attenuated varicella vaccine (Oka/SB Bio) in healthy children.
An Oka strain varicella vaccine developed by SmithKline Beecham Biologicals in the early 1980s is registered for immunization of high-risk groups in nine European countries. Because the preparation must be stored at -20 degrees C, it was reformulated to facilitate its use for general vaccination in healthy children with storage at 2-8 degrees C for 2 years. Studies using production lots of the reformulated vaccine in approximately 1400 healthy children are summarized. During the 42-day follow-up, no vaccine-related serious adverse events were reported. Unsolicited reactogenicity rates were low: 14.2% in children ages 9-36 months (the main target age group for the vaccine). Seroconversion rates were 98.6% after a single dose. Consistent reactogenicity and immunogenicity were observed across vaccine lots. After efficacy is demonstrated in other studies, widespread use of this vaccine will prevent a common and potentially serious childhood illness.
Meurice
F
F
Clinical Research and Development Dept., Smithkline Beecham Biologicals S.A., Rixensart, Belgium.
De Bouver
J L
JL
Vandevoorde
D
D
Woods
S
S
Bogaerts
H
H
D019433:Chickenpox Vaccine / Q000009:adverse effects / Q000276:immunology*; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007114:Immunization; D007223:Infant; D008297:Male; D014613:Vaccines, Attenuated / Q000276:immunology
D019433:Chickenpox Vaccine; D014613:Vaccines, Attenuated