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Vaccine
Available online 20 December 2012
In Press, Uncorrected Proof ? Note to users
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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
Carlos A. DiazGranadosa, Corresponding author contact information, E-mail the corresponding author,
Andrew J. Dunninga,
Emilia Jordanova,
Victoria Landolfia,
Martine Denisb,
H. Keipp Talbotc
a Sanofi Pasteur, 1 Discovery Drive, Swiftwater, PA 18370, USA
b Sanofi Pasteur, 1541 Avenue Marcel Merieux, 69280 Marcy-l??toile, France
c Vanderbilt University Medical Center, A2200 MCN, 1161 21st Ave S, Nashville, TN 37212, USA
http://dx.doi.org/10.1016/j.vaccine.2012.12.013, How to Cite or Link Using DOI
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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 (60 μg of hemagglutinin [HA] per strain) to standard dose (SD) vaccine (15 μg 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.
Highlights
► The high-dose vaccine was safe and well tolerated (comparable to standard dose). ► The high-dose vaccine induced superior immune responses. ► Efficacy assessments presented are only exploratory (limited numbers/precision). ► All viruses typified were classified as A/California/7/2009 (vaccine unmatched).
http://www.sciencedirect.com/science/article/pii/S0264410X1201780X
Available online 20 December 2012
In Press, Uncorrected Proof ? Note to users
Cover image
High-dose trivalent influenza vaccine compared to standard dose vaccine in elderly adults: Safety, immunogenicity and relative efficacy during the 2009?2010 season
Carlos A. DiazGranadosa, Corresponding author contact information, E-mail the corresponding author,
Andrew J. Dunninga,
Emilia Jordanova,
Victoria Landolfia,
Martine Denisb,
H. Keipp Talbotc
a Sanofi Pasteur, 1 Discovery Drive, Swiftwater, PA 18370, USA
b Sanofi Pasteur, 1541 Avenue Marcel Merieux, 69280 Marcy-l??toile, France
c Vanderbilt University Medical Center, A2200 MCN, 1161 21st Ave S, Nashville, TN 37212, USA
http://dx.doi.org/10.1016/j.vaccine.2012.12.013, How to Cite or Link Using DOI
Permissions & Reprints
View full text
Purchase $31.50
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 (60 μg of hemagglutinin [HA] per strain) to standard dose (SD) vaccine (15 μg 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.
Highlights
► The high-dose vaccine was safe and well tolerated (comparable to standard dose). ► The high-dose vaccine induced superior immune responses. ► Efficacy assessments presented are only exploratory (limited numbers/precision). ► All viruses typified were classified as A/California/7/2009 (vaccine unmatched).
http://www.sciencedirect.com/science/article/pii/S0264410X1201780X