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High-dose trivalent influenza vaccine compared to standard dose vaccine in elderly adults: safety, immunogenicity and relative efficacy during the 2009-2010 season.
Vaccine. 2013 Jan 30; 31(6):861-6.V

Abstract

BACKGROUND

High-dose trivalent influenza vaccine was developed to improve antibody responses to influenza vaccine in the elderly and hence potentially impact favorably on influenza-associated morbidity and mortality in this population.

METHODS

A phase IIIb, multicenter, randomized, double-blind, controlled trial was conducted to compare High-Dose (HD) trivalent inactivated influenza vaccine (60μg of hemagglutinin [HA] per strain) to standard dose (SD) vaccine (15μg of HA per strain) in adults ≥65 years of age. Assessments of safety (serious adverse events [SAE]), immunogenicity (hemagglutination inhibition [HAI] titers) and relative efficacy were performed during the 2009-2010 influenza season, which coincided with the H1N1 pandemic.

RESULTS

A total of 9172 participants were enrolled in 99 research centers in the US (6117 and 3055 randomized to the HD and SD groups, respectively). Within 180 days after vaccination, 6.7% and 6.5% of participants in the HD and SD vaccine groups, respectively, experienced at least one SAE, of which 0.4% and 0.3% had a fatal outcome. A total of 0.5% of participants in both groups discontinued the study due to a SAE. Post-vaccination HAI titers and rate of post-vaccination HAI titer ≥1:40 were significantly higher in the HD group. No cases of influenza caused by viral types/subtypes similar to those in the vaccines were observed. All cases genetically or antigenically characterized were classified as similar to influenza A/California/7/2009 (H1N1), the pandemic strain. The vaccine efficacy of HD vaccine relative to SD vaccine against any influenza viral type/subtype was 12.6% (95% CI -140.5; 65.8) in the intent-to-treat analysis.

CONCLUSION

High-dose trivalent inactivated influenza vaccine is safe and well tolerated and provides superior immune responses compared to standard dose vaccine. Demonstration of a superior vaccine efficacy requires a separate large randomized, controlled trial.

Authors+Show Affiliations

Sanofi Pasteur, 1 Discovery Drive, Swiftwater, PA 18370, USA. carlos.diazgranados@sanofipasteur.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23261045

Citation

DiazGranados, Carlos A., et al. "High-dose Trivalent Influenza Vaccine Compared to Standard Dose Vaccine in Elderly Adults: Safety, Immunogenicity and Relative Efficacy During the 2009-2010 Season." Vaccine, vol. 31, no. 6, 2013, pp. 861-6.
DiazGranados CA, Dunning AJ, Jordanov E, et al. High-dose trivalent influenza vaccine compared to standard dose vaccine in elderly adults: safety, immunogenicity and relative efficacy during the 2009-2010 season. Vaccine. 2013;31(6):861-6.
DiazGranados, C. A., Dunning, A. J., Jordanov, E., Landolfi, V., Denis, M., & Talbot, H. K. (2013). High-dose trivalent influenza vaccine compared to standard dose vaccine in elderly adults: safety, immunogenicity and relative efficacy during the 2009-2010 season. Vaccine, 31(6), 861-6. https://doi.org/10.1016/j.vaccine.2012.12.013
DiazGranados CA, et al. High-dose Trivalent Influenza Vaccine Compared to Standard Dose Vaccine in Elderly Adults: Safety, Immunogenicity and Relative Efficacy During the 2009-2010 Season. Vaccine. 2013 Jan 30;31(6):861-6. PubMed PMID: 23261045.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - High-dose trivalent influenza vaccine compared to standard dose vaccine in elderly adults: safety, immunogenicity and relative efficacy during the 2009-2010 season. AU - DiazGranados,Carlos A, AU - Dunning,Andrew J, AU - Jordanov,Emilia, AU - Landolfi,Victoria, AU - Denis,Martine, AU - Talbot,H Keipp, Y1 - 2012/12/20/ PY - 2012/10/29/received PY - 2012/12/03/revised PY - 2012/12/06/accepted PY - 2012/12/25/entrez PY - 2012/12/25/pubmed PY - 2013/7/3/medline SP - 861 EP - 6 JF - Vaccine JO - Vaccine VL - 31 IS - 6 N2 - BACKGROUND: High-dose trivalent influenza vaccine was developed to improve antibody responses to influenza vaccine in the elderly and hence potentially impact favorably on influenza-associated morbidity and mortality in this population. METHODS: A phase IIIb, multicenter, randomized, double-blind, controlled trial was conducted to compare High-Dose (HD) trivalent inactivated influenza vaccine (60μg of hemagglutinin [HA] per strain) to standard dose (SD) vaccine (15μg of HA per strain) in adults ≥65 years of age. Assessments of safety (serious adverse events [SAE]), immunogenicity (hemagglutination inhibition [HAI] titers) and relative efficacy were performed during the 2009-2010 influenza season, which coincided with the H1N1 pandemic. RESULTS: A total of 9172 participants were enrolled in 99 research centers in the US (6117 and 3055 randomized to the HD and SD groups, respectively). Within 180 days after vaccination, 6.7% and 6.5% of participants in the HD and SD vaccine groups, respectively, experienced at least one SAE, of which 0.4% and 0.3% had a fatal outcome. A total of 0.5% of participants in both groups discontinued the study due to a SAE. Post-vaccination HAI titers and rate of post-vaccination HAI titer ≥1:40 were significantly higher in the HD group. No cases of influenza caused by viral types/subtypes similar to those in the vaccines were observed. All cases genetically or antigenically characterized were classified as similar to influenza A/California/7/2009 (H1N1), the pandemic strain. The vaccine efficacy of HD vaccine relative to SD vaccine against any influenza viral type/subtype was 12.6% (95% CI -140.5; 65.8) in the intent-to-treat analysis. CONCLUSION: High-dose trivalent inactivated influenza vaccine is safe and well tolerated and provides superior immune responses compared to standard dose vaccine. Demonstration of a superior vaccine efficacy requires a separate large randomized, controlled trial. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/23261045/High_dose_trivalent_influenza_vaccine_compared_to_standard_dose_vaccine_in_elderly_adults:_safety_immunogenicity_and_relative_efficacy_during_the_2009_2010_season_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(12)01780-X DB - PRIME DP - Unbound Medicine ER -