Field performance of VAQTA (inactivated, purified hepatitis a vaccine) in Chinese children in Jiangsu.
Wang, Hua; Chen, X; Chen, Zhixian; Lu, W; Poerschke, Gabriele; Eves, Karen; Gress, Jacqueline; Kuter, Barbara.
Southeast Asian J Trop Med Public Health
; 2004 Dec; 35(4): 949-53
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en Inglés
| IMSEAR | ID: sea-34236
In Jiangsu, 30% of children between the ages of 5 and 8 years test seropositive for hepatitis A. The safety, tolerability, and immunogenicity of a 2-dose regimen (0, 6 months) of VAQTA (0.5 ml of 25U) administered IM in 50 healthy children aged 5 to 8 years without prior serological screening was evaluated. Blood samples were collected prior to the first dose and after each additional dose of VAQTA to determine the initial anti-HAV serostatus and response rates to the vaccine. Twelve children (24%) were initially seropositive and 38 (76%) were initially seronegative. Four weeks after the primary dose of VAQTA, 34 of the 38 subjects (89.5%, 95% CI 75 to 97) were anti-HAV seropositive. The geometric mean titer was 33.1 mIU/ml (95% CI 22.4 to 49.0). After the booster dose at 6 months, all the subjects were seropositive (37/37), giving a seroconversion of 100% (95% CI 90, 100). The geometric mean titer was 7585.8 mIU/ml (95% CI 5623.4 to 10,471.3). Adverse experiences were generally mild and transient. Results of this study are consistent with results from a previous double-blind randomized trial of this vaccine and confirm that VAQTA is highly immunogenic, and generally well-tolerated.
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