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Open, randomized study to compare the immunogenicity and reactogenicity of an influenza split vaccine with an MF59-adjuvanted subunit vaccine and a virosome-based subunit vaccine in elderly.

AbstractBACKGROUND:
An open, randomized, multicenter study was carried out in elderly to compare the immunogenicity and reactogenicity of a conventional influenza split vaccine (SpV) with an MF59-adjuvanted subunit vaccine (aSuV) and a virosome-based subunit vaccine (vSuV) since earlier studies reported better immunogenicity for adjuvanted and virosome-based vaccines.
PATIENTS AND METHODS:
A total of 840 subjects, aged 60 years or more, who had not been vaccinated or diagnosed with influenza in the preceding season were investigated. Hemagglutination-inhibition antibody titers were measured, and signs and symptoms recorded.
RESULTS:
The three vaccines exceeded EU efficacy requirements for subjects aged older than 60 years and seroprotective levels (titers > 1:40) were equally maintained with the three vaccines during 8 months post vaccination. SpV was as immunogenic as aSuV for the A/H3N2 strain (p < 0.0001) and significantly more immunogenic than aSuV for A/H1N1 strain (p = 0.0006). SpV was as immunogenic as vSuV for all three strains and significantly more immunogenic than vSuV for the A/H1N1 strain (p < 0.0001). In terms of reactogenicity, aSuV showed a higher rate of solicited local signs and symptoms than SpV (p = 0.021) and vSuV (p = 0.046), respectively. Incidence of solicited general symptoms was comparable on all treatments. No serious adverse event related to vaccination was reported.
CONCLUSION:
These findings suggest that all three vaccines are highly immunogenic with an acceptable reactogenicity profile and that they are appropriate for use in elderly.
AuthorsB R Ruf, K Colberg, M Frick, A Preusche
JournalInfection (Infection) Vol. 32 Issue 4 Pg. 191-8 (Aug 2004) ISSN: 0300-8126 [Print] Germany
PMID15293073 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial)
Chemical References
  • Adjuvants, Immunologic
  • Influenza Vaccines
  • MF59 oil emulsion
  • Polysorbates
  • Vaccines, Subunit
  • Vaccines, Virosome
  • Squalene
Topics
  • Adjuvants, Immunologic (pharmacology)
  • Age Factors
  • Aged
  • Antibody Formation
  • Female
  • Hemagglutination Inhibition Tests
  • Humans
  • Influenza Vaccines (adverse effects, immunology, pharmacology)
  • Influenza, Human (prevention & control)
  • Male
  • Middle Aged
  • Polysorbates (administration & dosage)
  • Squalene (administration & dosage, immunology)
  • Vaccines, Subunit (adverse effects, immunology, pharmacology)
  • Vaccines, Virosome (adverse effects, immunology, pharmacology)

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