Why the study?
Does the reformulated Oka strain varicella vaccine provide adequate immunogenicity and safety in healthy children?
Does the reformulated Oka strain varicella vaccine provide adequate immunogenicity and safety in healthy children?
The reformulated Oka strain varicella vaccine is highly immunogenic and safe in healthy children, supporting its widespread use to prevent childhood varicella.
Supports reformulated varicella vaccine in young children; hypothesis-generating and requires randomized confirmation before practice change.
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.
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Meurice et al. (1996) studied this question.
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