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Engerix B™

Hepatitis B recombinant vaccine

Product Overview

Engerix B is a Hepatitis B recombinant vaccine.

1ml of Engerix B contains 20micrograms of Hepatitis B surface antigen (HBsAg), adsorbed on 0.5mg aluminium hydroxide.

Engerix B  is produced in Saccharomyces cerevisiae yeast cells by recombinant DNA technology.

Engerix B  vaccine is indicated in adults and children, from birth onwards, for active immunisation against Hepatitis B virus (HBV) infection.

Engerix B  confers immunity against HBV infection by inducing specific anti-HBs antibodies

  • In individuals aged ≤15 years and those aged ≥16 years, protective efficacy rates were ≥96% at 7 months after the first dose when following the 0, 1 and 6 months schedule for Engerix B administration and 96% at 13 months after the first dose when using the 0, 1, 2, and 12 months immunisation schedule.
  • Engerix B vaccine administered at 0, 7, and 21 days and then 12 months in individuals aged ≥ 18 years has shown 65% efficacy at day 28, 76% protective efficacy at 2 months after the first dose and 99% efficacy 13 months after the first dose.
  • In patients aged ≥16 years with renal insufficiency, Engerix B (2 x 20 microgram doses) administered at 0, 1, 2 and 6 months achieved a protective efficacy of 55% at month 3 and 87% at month 7.

Engerix B is available as a suspension for intramuscular injection, supplied in a vial or pre-filled syringe.

Engerix B is contraindicated in individuals with documented hypersensitivity to the vaccine or any of its components.

Engerix B administration should not be performed in individuals with acute severe febrile illness.

 

For further information on Hepatitis B recombinant vaccine please see the Engerix B  Summary of Product Characteristics (SPC).  [1]  

 

References:

  1. Engerix B 20 micrograms/1 ml Suspension for injection, Hepatitis B recombinant Vaccine, adsorbed Summary of Product Characteristics.

B.M.: Last updated 07 September 2010: UK/COM/0047/10