Reactogenicity and immunogenicity of a live-attenuated refrigerator-stable varicella vaccine (Oka strain) in healthy seronegative subjects age 10 months to 12 years

Sri Rezeki S. Harun Hadinegoro, Hindra Irawan Satari, H. H. Han, S. Gatchalian, H. L. Bock

Research output: Contribution to journalArticlepeer-review

7 Citations (Scopus)

Abstract

This study assessed the immunogenicity and reactogenicity of a live-attenuated varicella vaccine (Oka strain), Varilrix™ in Indonesian childrer 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°C) was infrequent. No grade 3 insolicited 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 satety issues when administered as a single dose primary vaccination to healthy, seronegative Indonesian subjects age 10 months to 12 years.

Original languageEnglish
Pages (from-to)991-999
Number of pages9
JournalSoutheast Asian Journal of Tropical Medicine and Public Health
Volume40
Issue number5
Publication statusPublished - 1 Sep 2009

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