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.
Hadinegoro
S R H
SR
Division of Infection and Tropical Pediatric, Department of Child Health, Medical School, University of Indonesia, Ciptomangunkusumo General Hospital, Jakarta, Indonesia. srh3546@centrin.net.id
Hindra
I S
IS
Han
H H
HH
Gatchalian
S
S
Bock
H L
HL
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