Bruno Granwehr, MD, MS
What is the immunogenicity and safety of a monovalent MF59-adjuvanted influenza A (H1N1) 2009 vaccine?
Interim analysis of a randomized controlled trial. ClinicalTrials.gov NCT00943358.
Unclear allocation concealment.*
Unclear if blinded.*
Single center in Leicester, England, UK.
100 adults 18 to 50 years of age (median age 33 y, 65% women) who were healthy or had a stable medical condition. Exclusion criteria included lactation or pregnancy; parenteral blood products or immunoglobulins in the past 3 months; immunosuppressive disease or medications; acute respiratory disorders requiring systemic antibiotic or antiviral treatment in the past 7 days; temperature > 38°C in the past 3 days; and confirmed pandemic influenza H1 infection.
Two 7.5-µg doses of monovalent, inactivated, MF59-adjuvanted influenza A (H1N1) 2009 vaccine given concurrently on day 0 (n = 25) or 1 on day 0 and the other on day 7 (n = 25), day 14 (n = 25), or day 21 (n = 25).
Geometric mean titers, proportion of persons with seroconversion (increase in hemagglutination-inhibition [HI] antibody titer from ≤ 1:10 to ≥ 1:40 or from ≥ 1:10 by a factor ≥ 4) or seroprotection (HI antibody titer ≥ 1:40), and adverse effects. The 2nd dose in the day 21 group was given after day 21 assessment, and response to the 2nd dose in this group was not reported.
4% to 12% of persons had seroprotection before vaccination. Groups did not differ for immunogenicity at day 21 (Table). Mild muscle aches were more common with 2 vaccine doses on day 0 than in other dose groups (52% vs 16% to 32%, P = 0.02); groups did not differ for other local or systemic adverse effects.
In adults, single and double 7.5-µg doses of MF59-adjuvanted influenza A (H1N1) 2009 vaccine did not differ for immunogenicity within 21 days.
Two 7.5-µg doses of MF59-adjuvanted influenza A (H1N1) 2009 vaccine given on different schedules†
†HI = hemagglutination-inhibition; other abbreviations defined in Glossary. RBI, NNT, and CI calculated from data in article.
‡Second dose given after assessment on day 21.
§HI antibody titer increase from ≤ 1:10 to ≥ 1:40 or from ≥ 1:10 by a factor ≥ 4.
Granwehr B. One or two 7.5-µg doses of MF59-adjuvanted influenza A (H1N1) 2009 vaccine was immunogenic in adults within 21 days. Ann Intern Med. ;152:JC1–8. doi: 10.7326/0003-4819-152-2-201001190-02008
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Published: Ann Intern Med. 2010;152(2):JC1-8.
Infectious Disease, Influenza, Prevention/Screening, Vaccines/Immunization.
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