Abstract | BACKGROUND: 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.
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Authors | B R Ruf, K Colberg, M Frick, A Preusche |
Journal | Infection
(Infection)
Vol. 32
Issue 4
Pg. 191-8
(Aug 2004)
ISSN: 0300-8126 [Print] Germany |
PMID | 15293073
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Adjuvants, Immunologic
- Influenza Vaccines
- MF59 oil emulsion
- Polysorbates
- Vaccines, Subunit
- Vaccines, Virosome
- Squalene
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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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