AVAXIM^® JUNIOR

Summary

*Seroconversion defined as anti-HAV antibody titres rising from <20 mlU/ml (seronegative) to ≥20 mIU/ml. Monocentric, open trial evaluating Avaxim in children aged 18 months – 3 years (n=37), 4 – 8 years (n=53) and 9-15 years (n=83). Two weeks after the first dose, seroconversion was achieved by 94.6% of initially HAV-seronegative subjects aged 18 months – 3 years, 94.3% of subjects aged 4-8 years and 96.4% of subjects aged 9-15 years.²

^†One study was conducted in children (N=54) aged 12 through 47 months vaccinated with 2 doses of the vaccine 6 months apart. The results showed a persistence of the antibodies for a period up to 14-15 years at levels considered as protective and do not suggest a need for new administration of the vaccine. A statistical model using the available data from this study until 14-15 years after the administration of the 2 doses of the vaccine predicts a persistence of the protective anti-HAV antibodies for at least 30 years in 87.5% of these children (estimated prediction within the 95% confidence interval CI[74.1; 94.8]).³ Another long-term persistence study was conducted in Argentina with children aged between 11 and 23 months at the time of inclusion. All children had received routine vaccination with 1 dose (Group 1: N = 436) or 2 doses (Group 2: N = 108) of hepatitis A vaccine. After 15 years of follow-up, all remaining subjects showed anti HAV antibodies concentration ≥10 mIU/mL (using ATELLICA) indicative of seroprotection for up to 15 years after 1 or 2 doses. Statistical modelling using data from HAF82 (covering Year 0 to Year 15) including natural boosting effect, predicts that 94% [89-98] of subjects having received one vaccine dose and 93% [88-97] of subjects having received two vaccine doses will have anti-HAV titers above the threshold for seroprotection for up to 40 years after the first administration.⁴

.