AVAXIM Suspension for injection in a prefilled syringe Ref.[28228] Active ingredients: Hepatitis A, inactivated vaccine

Source: Υπουργείο Υγείας (CY)  Revision Year: 2021  Publisher: SANOFI PASTEUR, 14 Espace Henry Vallee, 69007 Lyon, France

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Vaccine against hepatitis A
ATC code: J07BC02

This vaccine is prepared from hepatitis A virus cultured, purified and then inactivated by formaldehyde. It confers immunity against hepatitis A virus by inducing a higher antibody response than that obtained after passive immunisation with immunoglobulins. The antibodies appear soon after the first injection, and 14 days after vaccination, more than 90% of immunocompetent subjects are seroprotected (titres above 20 mIU/ml).

One month after the first injection, almost 100% of subjects have titres higher than 20 mIU/ml. Immunity may persist up to the 36th month. In a study with 103 healthy subjects whose serology levels were monitored for 3 years after the first injection of AVAXIM 160 U, 99% still had, by the 36th month, antibody titres of at least 20 mIU/ml against the hepatitis A virus.

Long-term persistence of a protective antibody level against the hepatitis A virus after a second dose (booster) of AVAXIM 160 U is not currently established. However, the available data suggest that the antibodies against the hepatitis A virus persist beyond 10 years after the second dose in healthy people.

5.2. Pharmacokinetic properties

Not applicable.

5.3. Preclinical safety data

Non clinical data reveal no special hazard for humans based on conventional studies of acute toxicity, repeated dose toxicity, local tolerance and hypersensitivity.

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