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Randomized, double-blind controlled phase 3 trial comparing the immunogenicity of high-dose and standard-dose influenza vaccine in adults 65 years of age and older.
J Infect Dis. 2009 Jul 15; 200(2):172-80.JI

Abstract

BACKGROUND

Influenza-associated morbidity and mortality has not decreased in the last decade, despite increased receipt of vaccine. To improve the immunogenicity of influenza vaccine, a high-dose (HD) trivalent, inactivated influenza vaccine was developed.

METHODS

A multicenter, randomized, double-blind controlled study was conducted to compare HD vaccine (which contains 60 microg of hemagglutinin per strain) with the licensed standard-dose (SD) vaccine (which contains 15 microg of hemagglutinin per strain) in adults > or = 65 years of age.

RESULTS

HD vaccine was administered to 2575 subjects, and SD vaccine was administered to 1262 subjects. There was a statistically significant increase in the rates of seroconversion and mean hemagglutination inhibition titers at day 28 after vaccination among those who received HD vaccine, compared with those who received SD vaccine. Mean postvaccination titers for individuals who received HD vaccine were 116 for H1N1, 609 for H3N2, and 69 for B strain; for those who received SD vaccine, mean postvaccination titers were as 67 for H1N1, 333 for H3N2, and 52 for B strain. The HD vaccine met superiority criteria for both A strains, and the responses for B strain met non-inferiority criteria. Seroprotection rates were also higher for those who received HD vaccine than for those who received SD vaccine vaccine, for all strains. Local reactions were more frequent in individuals who received HD vaccine, but the reactions were mild to moderate.

CONCLUSIONS

There was a statistically significant increase in the level of antibody response induced by HD influenza vaccine, compared with that induced by SD vaccine, without an attendant increase in the rate or severity of clinically relevant adverse reactions. These results suggest that the high-dose vaccine may provide improved protective benefits for older adults.

TRIAL REGISTRATION

ClinicalTrials.gov identifier: NCT00391053 .

Authors+Show Affiliations

Department of Medicine, Rochester General Hospital, Rochester, NY, USA. ann.falsey@viahealth.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

19508159

Citation

Falsey, Ann R., et al. "Randomized, Double-blind Controlled Phase 3 Trial Comparing the Immunogenicity of High-dose and Standard-dose Influenza Vaccine in Adults 65 Years of Age and Older." The Journal of Infectious Diseases, vol. 200, no. 2, 2009, pp. 172-80.
Falsey AR, Treanor JJ, Tornieporth N, et al. Randomized, double-blind controlled phase 3 trial comparing the immunogenicity of high-dose and standard-dose influenza vaccine in adults 65 years of age and older. J Infect Dis. 2009;200(2):172-80.
Falsey, A. R., Treanor, J. J., Tornieporth, N., Capellan, J., & Gorse, G. J. (2009). Randomized, double-blind controlled phase 3 trial comparing the immunogenicity of high-dose and standard-dose influenza vaccine in adults 65 years of age and older. The Journal of Infectious Diseases, 200(2), 172-80. https://doi.org/10.1086/599790
Falsey AR, et al. Randomized, Double-blind Controlled Phase 3 Trial Comparing the Immunogenicity of High-dose and Standard-dose Influenza Vaccine in Adults 65 Years of Age and Older. J Infect Dis. 2009 Jul 15;200(2):172-80. PubMed PMID: 19508159.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomized, double-blind controlled phase 3 trial comparing the immunogenicity of high-dose and standard-dose influenza vaccine in adults 65 years of age and older. AU - Falsey,Ann R, AU - Treanor,John J, AU - Tornieporth,Nadia, AU - Capellan,Jose, AU - Gorse,Geoffrey J, PY - 2009/6/11/entrez PY - 2009/6/11/pubmed PY - 2009/8/22/medline SP - 172 EP - 80 JF - The Journal of infectious diseases JO - J. Infect. Dis. VL - 200 IS - 2 N2 - BACKGROUND: Influenza-associated morbidity and mortality has not decreased in the last decade, despite increased receipt of vaccine. To improve the immunogenicity of influenza vaccine, a high-dose (HD) trivalent, inactivated influenza vaccine was developed. METHODS: A multicenter, randomized, double-blind controlled study was conducted to compare HD vaccine (which contains 60 microg of hemagglutinin per strain) with the licensed standard-dose (SD) vaccine (which contains 15 microg of hemagglutinin per strain) in adults > or = 65 years of age. RESULTS: HD vaccine was administered to 2575 subjects, and SD vaccine was administered to 1262 subjects. There was a statistically significant increase in the rates of seroconversion and mean hemagglutination inhibition titers at day 28 after vaccination among those who received HD vaccine, compared with those who received SD vaccine. Mean postvaccination titers for individuals who received HD vaccine were 116 for H1N1, 609 for H3N2, and 69 for B strain; for those who received SD vaccine, mean postvaccination titers were as 67 for H1N1, 333 for H3N2, and 52 for B strain. The HD vaccine met superiority criteria for both A strains, and the responses for B strain met non-inferiority criteria. Seroprotection rates were also higher for those who received HD vaccine than for those who received SD vaccine vaccine, for all strains. Local reactions were more frequent in individuals who received HD vaccine, but the reactions were mild to moderate. CONCLUSIONS: There was a statistically significant increase in the level of antibody response induced by HD influenza vaccine, compared with that induced by SD vaccine, without an attendant increase in the rate or severity of clinically relevant adverse reactions. These results suggest that the high-dose vaccine may provide improved protective benefits for older adults. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00391053 . SN - 0022-1899 UR - https://www.unboundmedicine.com/medline/citation/19508159/Randomized_double_blind_controlled_phase_3_trial_comparing_the_immunogenicity_of_high_dose_and_standard_dose_influenza_vaccine_in_adults_65_years_of_age_and_older_ L2 - https://academic.oup.com/jid/article-lookup/doi/10.1086/599790 DB - PRIME DP - Unbound Medicine ER -