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Live Oka/Merck Varicella Vaccine in Healthy ChildrenFurther Clinical and Laboratory Assessment
Robert E. Weibel, MD;
Barbara J. Kuter, MPH;
Beverly J. Neff, PhD;
Carol A. Rothenberger, RN;
Alison J. Fitzgerald, BSN;
Karen A. Connor, BSN, PNP;
David Morton, BS;
Arlene A. McLean, PhD;
Edward M. Scolnick, MD
JAMA. 1985;254(17):2435-2439.
Abstract
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A clinical trial among 137 healthy children, ages 1 to 12 years, was conducted with four different doses (4,350, 870, 435, and 43 plaque-forming units [pfu]) of live Oka/Merck varicella vaccine to evaluate clinical reactions and selected laboratory parameters and to determine the minimum effective dose and induction time of antibody. The vaccine was well tolerated with no significant difference in the rate of reported symptoms by dose. The frequency of varicellalike rash was 3% (4/137); all rashes were mild. Serum aminotransferase values were essentially unchanged after vaccination. Minor variations found in platelet counts after vaccination were not associated with any bleeding, bruising, or clotting. Among initially seronegative children who received doses of 435 pfu or greater, 94% assayed at two weeks and 100% assayed at four or six weeks seroconverted. The geometric mean titers were similar for all four doses at six weeks. IgG and IgA responses were demonstrated with no relation to the vaccine dose.
(JAMA 1985;254:2435-2439)
Author Affiliations
From the Department of Pediatrics, University of Pennsylvania, Philadelphia (Dr Weibel and Mss Rothenberger, Fitzgerald, and Connor); and the Department of Virus and Cell Biology Research, Merck Sharp & Dohme Research Laboratories, West Point, Pa (Ms Kuter, Drs Neff, McLean, and Scolnick, and Mr Morton).
Footnotes
Reprint requests to Department of Pediatrics, Children's Hospital of Philadelphia, University of Pennsylvania, 34th Street and Civic Center Boulevard, Philadelphia, PA 29204 (Dr Weibel).
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