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Clin Vaccine Immunol. 2012 Jan 4. [Epub ahead of print]
A reduced dose seasonal trivalent influenza vaccine is safe and immunogenic in adult and elderly patients - a randomized controlled trial.
Vajo Z, Ferenc T, Jankovics I.
Source
University of Debrecen, Medical and Health Sciences Center, Debrecen, Hungary (ZV); National Institute of Epidemiology, Budapest, Hungary (IJ); State Primary Care Center, Pilisvorosvar, Hungary (TF).
Abstract
Background: With the recent pandemic of influenza A (H1N1) and vaccine shortages, there has been a considerable interest of developing influenza vaccines with reduced doses, allowing for increased production capacity.Design: Here we report a prospective, randomized, double-blind, single-center clinical trial of a reduced-dose whole-virion inactivated, adjuvanted influenza vaccine in adult and elderly volunteers.Methods: A total of 234 subjects including 120 adults (18-60 years of age) and 114 elderly subjects (>60 years of age) were enrolled to receive either 6 μg or the conventional 15 μg doses of seasonal trivalent influenza vaccines. The subjects were followed for safety analysis, and serum samples were obtained to assess immunogenicity by hemagglutination inhibition testing.Results: The subjects developed antibody responses against the seasonal influenza A H1N1 and H3N2 strains, as well as the seasonal influenza B virus included in the vaccines. Single doses of 6 μg fulfilled licensing criteria for seasonal influenza vaccines. No significant differences of rates of seroconversion, seroprotection or geometric mean titers were found between the two doses. All adverse events were rare, mild and transient.Conclusions: We found that the present reduced dose vaccine is safe and immunogenic in healthy adult and elderly subjects and triggers immune responses to comply with licensing criteria.
PMID:
22219315
[PubMed - as supplied by publisher]
A reduced dose seasonal trivalent influenza vaccine is safe and immunogenic in adult and elderly patients - a randomized controlled trial.
Vajo Z, Ferenc T, Jankovics I.
Source
University of Debrecen, Medical and Health Sciences Center, Debrecen, Hungary (ZV); National Institute of Epidemiology, Budapest, Hungary (IJ); State Primary Care Center, Pilisvorosvar, Hungary (TF).
Abstract
Background: With the recent pandemic of influenza A (H1N1) and vaccine shortages, there has been a considerable interest of developing influenza vaccines with reduced doses, allowing for increased production capacity.Design: Here we report a prospective, randomized, double-blind, single-center clinical trial of a reduced-dose whole-virion inactivated, adjuvanted influenza vaccine in adult and elderly volunteers.Methods: A total of 234 subjects including 120 adults (18-60 years of age) and 114 elderly subjects (>60 years of age) were enrolled to receive either 6 μg or the conventional 15 μg doses of seasonal trivalent influenza vaccines. The subjects were followed for safety analysis, and serum samples were obtained to assess immunogenicity by hemagglutination inhibition testing.Results: The subjects developed antibody responses against the seasonal influenza A H1N1 and H3N2 strains, as well as the seasonal influenza B virus included in the vaccines. Single doses of 6 μg fulfilled licensing criteria for seasonal influenza vaccines. No significant differences of rates of seroconversion, seroprotection or geometric mean titers were found between the two doses. All adverse events were rare, mild and transient.Conclusions: We found that the present reduced dose vaccine is safe and immunogenic in healthy adult and elderly subjects and triggers immune responses to comply with licensing criteria.
PMID:
22219315
[PubMed - as supplied by publisher]
