Ten Years of Experience with the Trivalent Split-Influenza Vaccine, Fluarixâ„¢

Hehme, N.W.; Künzel, W.; Petschke, F.; Türk, G.; Raderecht, C.; van Hoecke, C.; Sänger, R.
November 2002
Clinical Drug Investigation;2002, Vol. 22 Issue 11, p751
Academic Journal
Background: The trivalent inactivated split-influenza vaccine, Fluarix™, has been available since 1992. Aim: To assess the safety and immunogenicity of the vaccine from studies in healthy adults and the elderly performed from 1992 to 2001 to comply with European Union registration requirements, and from studies in children and populations at high risk of severe influenza illness or influenza-related complications. Methods: Annual registration studies were performed in healthy adults aged 18-60 years and the elderly aged >60 years. Six studies in children aged 6 months-18 years, and five studies in adults with high-risk conditions, were done during the same period. The high-risk populations included immunosuppressed patients with solid tumours or systemic malignancies, renal or liver transplant recipients, and patients with chronic obstructive pulmonary disease or insulin-dependent diabetes mellitus. Adults and children aged >36 months received 0.5ml of the vaccine by intramuscular or deep subcutaneous injection. Children aged 6-35 months received 0.25ml; in some children not previously vaccinated or exposed to influenza, a second dose was given 4 weeks later. Immunogenicity was determined by measuring haemagglutination inhibiting antibodies just before and 21 ± 2 days after vaccination. Redness, swelling, induration and pain at the injection site were recorded, along with systemic symptoms such as fever. Results: In all registration studies (n = 1 558), the vaccine consistently exceeded European Union immunogenicity criteria. Geometric mean titres in adults peaked 21 days after vaccination and remained above the protection level for all three strains for up to 12 months. In healthy adults and the elderly, seroprotection rates were 69-100% and consistently exceeded 82% from 1996. Immunogenicity in children (n = 364) and high-risk populations (n = 285) exceeded the targets for healthy adults. The vaccine was well tolerated in all age groups and populations. The most frequently reported symptoms in healthy adults and the elderly were local redness of >20mm (10-31%) and swelling of >20mm (11-16%). The incidence of fever >38.5°C was ≤4% in healthy adults and high-risk groups; fever of >37°C was also rare (0-5%) in children over 6 years old, but was more frequent in younger children (11-27%). The reactogenicity of the vaccine was low in the high-risk populations. Conclusions: Fluarix™ has a good safety profile and is highly immunogenic in all age groups as well as in high-risk populations. The all-year persistence of antibodies means that the vaccine gives protection for the entire influenza season.


Related Articles

  • Correction.  // Contemporary Pediatrics;Aug2003, Vol. 20 Issue 8, p17 

    Presents a correction to a statement about flu vaccine in the column "Updates" that was previously published in the June 2003 issue.

  • Beware: The Beijing flu is coming. Butler, Robert N. // Geriatrics;Sep93, Vol. 48 Issue 9, p17 

    Editorial. Cautions against the Beijing strain of influenza A virus that is anticipated to hit the United States. Inclusion of mutated Beijing strain in vaccine; Main classes of influenza virus; Increase in genetically mixed influenza A viruses; Estimated number of people who die during flu...

  • Recently asked Questions.  // South African Pharmaceutical Journal;2013, Vol. 80 Issue 2, p10 

    The article presents questions and answers related to influenza vaccination.

  • Avoid the high-dose flu vaccine.  // Consumer Reports on Health;Jan2013, Vol. 25 Issue 1, p3 

    The article discusses the Fluzone High-Dose vaccine for influenza and discusses side effects linked to the vaccine which made the journal "Consumer Reports on Health" recommend that consumers avoid getting the vaccine.

  • CNE /CME Questions.  // Hospital Infection Control & Prevention;Jan2013, Vol. 40 Issue 1, p11 

    A continuing nursing education (CNE) / continuing medical education (CME) quiz on the influenza vaccine is presented.

  • Influenza vaccine, 1999-2000. Maudlin, Robert K. // Modern Medicine;Nov99, Vol. 67 Issue 11, p58 

    Offers information on trivalent influenza vaccines. Indications; Dosages; Side effects.

  • Influenza vaccine.  // Presidents & Prime Ministers;Mar/Apr97, Vol. 6 Issue 2, p31 

    Announces the composition of the influenza vaccine for the 1997-1998 season at a meeting of international experts held at the World Health Organization's headquarters. Purpose of the meeting; How the timing of the recommendation of vaccines are critical before the new influenza season; Number...

  • Flu Season: To Vaccinate or Not to Vaccinate?  // Atlanta Tribune;Oct2013, Vol. 27 Issue 7, p13 

    The article discusses the flu vaccines offered in the U.S. for the 2013-2014 flu season.

  • Trivalent influenza vaccine: It may be time to step up our game. Shihadeh, Kati // Infectious Disease News;Oct2013, Vol. 26 Issue 10, p31 

    The article discusses the dilemma among U.S. hospitals over whether they will purchase the quadrivalent influenza vaccine for the 2013-2013 influenza season.


Read the Article


Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics