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
- PMID: 19508159
- DOI: 10.1086/599790
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
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 .
Comment in
-
The imperative of influenza vaccines for elderly individuals-an evolving story.J Infect Dis. 2009 Jul 15;200(2):161-3. doi: 10.1086/599791. J Infect Dis. 2009. PMID: 19508160 Free PMC article. No abstract available.
-
Statins and influenza: can we move forward?J Infect Dis. 2012 Jan 1;205(1):1-3. doi: 10.1093/infdis/jir693. Epub 2011 Dec 13. J Infect Dis. 2012. PMID: 22170953 Free PMC article. No abstract available.
-
Sometimes, more is better.J Infect Dis. 2012 Mar 1;205(5):697-9. doi: 10.1093/infdis/jir838. Epub 2012 Jan 24. J Infect Dis. 2012. PMID: 22275400 Free PMC article. No abstract available.
Similar articles
-
Immunization with trivalent inactivated influenza vaccine in partially immunized toddlers.Pediatrics. 2006 Sep;118(3):e579-85. doi: 10.1542/peds.2006-0201. Pediatrics. 2006. PMID: 16950949 Clinical Trial.
-
Immunogenicity and safety of Fluzone(®) intradermal and high-dose influenza vaccines in older adults ≥65 years of age: a randomized, controlled, phase II trial.Vaccine. 2014 May 1;32(21):2507-17. doi: 10.1016/j.vaccine.2013.09.074. Epub 2013 Oct 11. Vaccine. 2014. PMID: 24120672 Clinical Trial.
-
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. doi: 10.1016/j.vaccine.2012.12.013. Epub 2012 Dec 20. Vaccine. 2013. PMID: 23261045 Clinical Trial.
-
Fluzone® High-Dose Influenza Vaccine.Expert Rev Vaccines. 2016 Dec;15(12):1495-1505. doi: 10.1080/14760584.2016.1254044. Epub 2016 Nov 14. Expert Rev Vaccines. 2016. PMID: 27813430 Review.
-
High-Dose Inactivated Influenza Vaccine Quadrivalent for Older Adults.Ann Pharmacother. 2021 Jan;55(1):89-97. doi: 10.1177/1060028020935645. Epub 2020 Jun 24. Ann Pharmacother. 2021. PMID: 32578447 Review.
Cited by
-
The roles of CD4+ T cell help, sex, and dose in the induction of protective CD8+ T cells against a lethal poxvirus by mRNA-LNP vaccines.Mol Ther Nucleic Acids. 2024 Jul 20;35(3):102279. doi: 10.1016/j.omtn.2024.102279. eCollection 2024 Sep 10. Mol Ther Nucleic Acids. 2024. PMID: 39188304 Free PMC article.
-
Routine and Special Vaccinations in People With HIV.Top Antivir Med. 2024 Apr 18;32(2):411-419. Top Antivir Med. 2024. PMID: 39141919 Free PMC article. Review.
-
Trivalent and quadrivalent seasonal influenza vaccine in adults aged 60 and older: a systematic review and network meta-analysis.BMJ Evid Based Med. 2024 Jul 23;29(4):239-254. doi: 10.1136/bmjebm-2023-112767. BMJ Evid Based Med. 2024. PMID: 38604619 Free PMC article.
-
High-Dose Quadrivalent Influenza Vaccine for Prevention of Cardiovascular and Respiratory Hospitalizations in Older Adults.Influenza Other Respir Viruses. 2024 Apr;18(4):e13270. doi: 10.1111/irv.13270. Influenza Other Respir Viruses. 2024. PMID: 38569647 Free PMC article. Clinical Trial.
-
Influenza A(H3N2) Antibody Responses to Standard-Dose Versus Enhanced Influenza Vaccine Immunogenicity in Older Adults and Prior Season's Vaccine Status.J Infect Dis. 2024 May 15;229(5):1451-1459. doi: 10.1093/infdis/jiad497. J Infect Dis. 2024. PMID: 37950884 Clinical Trial.
Publication types
MeSH terms
Substances
Associated data
LinkOut - more resources
Full Text Sources
Medical
Miscellaneous