TY - JOUR
T1 - Reactogenicity and immunogenicity of a live-attenuated refrigerator-stable varicella vaccine (Oka strain) in healthy seronegative subjects age 10 months to 12 years
AU - Hadinegoro, Sri Rezeki S. Harun
AU - Satari, Hindra Irawan
AU - Han, H. H.
AU - Gatchalian, S.
AU - Bock, H. L.
PY - 2009/9
Y1 - 2009/9
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=70349817128&partnerID=8YFLogxK
M3 - Article
C2 - 19842382
AN - SCOPUS:70349817128
SN - 0125-1562
VL - 40
SP - 991
EP - 999
JO - Southeast Asian Journal of Tropical Medicine and Public Health
JF - Southeast Asian Journal of Tropical Medicine and Public Health
IS - 5
ER -