Reactogenicity and immunogenicity of a live-attenuated refrigerator-stable varicella vaccine (OKA strain) in healthy seronegative subjects age 10 months to 12 years.
This study assessed the immunogenicity and reactogenicity of a live-attenuated varicella vaccine (Oka strain), Varilrix in Indonesian children age 10 months to 12 years. A total of 300 seronegative subjects were stratified into three age subgroups (10 months to < 3 years, 3 years to < 7 years and 7 to 12 years) and all received a single-dose of Oka strain varicella vaccine. One solicited local symptom (injection site soreness) was reported during the 43-day post-vaccination follow-up period. Fever (29/295; 10%) was more prevalent than rash (3/295; 1%) but the incidence of grade 3 fever (defined as axillary temperature of >39 degrees C) was infrequent. No grade 3 unsolicited events and no serious adverse events were reported. The vaccine proved to be immunogenic in all age groups; all but one subject seroconverted for anti-varicella antibodies 43-days post-vaccination. This study demonstrated that the live-attenuated varicella vaccine (Oka strain) was well tolerated and immunogenic with no safety issues when administered as a single dose primary vaccination to healthy, seronegative Indonesian subjects age 10 months to 12 years.
Division of Infection and Tropical Pediatric, Department of Child Health, Medical School, University of Indonesia, Ciptomangunkusumo General Hospital, Jakarta, Indonesia. srh3546@centrin.net.id
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Hadinegoro
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Hindra
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Han
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Gatchalian
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HL
Bock
D000367:Age Factors; D019433:Chickenpox Vaccine / Q000009:adverse effects / Q000276:immunology*; D002648:Child; D002675:Child, Preschool; D004355:Drug Stability; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood; D007214:Indonesia; D007223:Infant; D008297:Male; D013696:Temperature; D014613:Vaccines, Attenuated / Q000009:adverse effects / Q000276:immunology
D019433:Chickenpox Vaccine; D007074:Immunoglobulin G; D014613:Vaccines, Attenuated