Pharmacological properties : תכונות פרמקולוגיות

Pharmacodynamic Properties

5.1     Pharmacodynamic properties
Pharmacotherapeutic group: Viral vaccine, ATC code: J07BC02.
This vaccine is prepared from hepatitis A virus cultured, harvested, purified and then inactivated by formaldehyde.
It confers immunity against hepatitis A virus (HAV) by inducing anti-HAV antibody titres longer lasting and higher than those obtained after passive immunisation with immunoglobulins. This vaccine has been demonstrated to elicit protective anti-HAV antibody titres (≥20 mIU/mL) within two weeks following the injection in over 95% of individuals and in 100% of individuals before the booster dose administered 6 months after the first dose.
A study conducted in Argentina (an area of intermediate endemicity for hepatis A) enabled the evaluation of long term persistence of anti-HAV antibodies in children aged 12 months to 47 months vaccinated with 2 doses of Avaxim 80 U Pediatric 6 months apart. The results show a persistence of the antibodies until 14–15 years at levels considered as protective and do not suggest the need for new administration of the vaccine.
A mathematical model using the available data from this study until 14–15 years after administration of the 2 doses of Avaxim 80 U Pediatric predicts a persistence of the protective anti-HAV antibodies for at least 30 years in 87.5% (CI 95%: 74.1; 94.8) of these children.

Pharmacokinetic Properties

5.2     Pharmacokinetic properties
Not applicable.