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Intradermal influenza vaccine for older adults: a randomized controlled multicenter phase III study.
Vaccine. 2009 Dec 09; 27(52):7304-12.V

Abstract

In a 3-year, randomized, controlled, open-label phase III trial enrolling 3707 adults aged > or = 60 years we evaluated whether the immunogenicity of an intradermal trivalent inactivated seasonal influenza vaccine, containing 15 microg of haemagglutinin per strain per 0.1 ml dose, is superior to that of a conventional intramuscular vaccine. Intradermal vaccine was given using an intradermal microinjection system. After the first vaccination, both vaccines satisfied the immunogenicity criteria for influenza vaccines for older adults set out in European regulatory guidelines, and geometric mean haemagglutination inhibition antibody titers and seroprotection rates were higher (statistically superior) with intradermal vaccination. Higher immune responses with intradermal vaccine were also observed after the 2nd and 3rd annual vaccinations. Both vaccines were well tolerated with similar systemic reactogenicity profiles. This intradermal influenza vaccine for older adults is a beneficial option for influenza protection, consistently enhancing antibody responses without compromising safety.

Authors+Show Affiliations

ALTI Clinical Research Network, 49000 Angers, France.No affiliation info availableNo 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

19849996

Citation

Arnou, Robert, et al. "Intradermal Influenza Vaccine for Older Adults: a Randomized Controlled Multicenter Phase III Study." Vaccine, vol. 27, no. 52, 2009, pp. 7304-12.
Arnou R, Icardi G, De Decker M, et al. Intradermal influenza vaccine for older adults: a randomized controlled multicenter phase III study. Vaccine. 2009;27(52):7304-12.
Arnou, R., Icardi, G., De Decker, M., Ambrozaitis, A., Kazek, M. P., Weber, F., & Van Damme, P. (2009). Intradermal influenza vaccine for older adults: a randomized controlled multicenter phase III study. Vaccine, 27(52), 7304-12. https://doi.org/10.1016/j.vaccine.2009.10.033
Arnou R, et al. Intradermal Influenza Vaccine for Older Adults: a Randomized Controlled Multicenter Phase III Study. Vaccine. 2009 Dec 9;27(52):7304-12. PubMed PMID: 19849996.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Intradermal influenza vaccine for older adults: a randomized controlled multicenter phase III study. AU - Arnou,Robert, AU - Icardi,Giancarlo, AU - De Decker,Marijke, AU - Ambrozaitis,Arvydas, AU - Kazek,Marie-Pierre, AU - Weber,Françoise, AU - Van Damme,Pierre, Y1 - 2009/10/20/ PY - 2009/06/04/received PY - 2009/10/01/revised PY - 2009/10/08/accepted PY - 2009/10/24/entrez PY - 2009/10/24/pubmed PY - 2010/1/23/medline SP - 7304 EP - 12 JF - Vaccine JO - Vaccine VL - 27 IS - 52 N2 - In a 3-year, randomized, controlled, open-label phase III trial enrolling 3707 adults aged > or = 60 years we evaluated whether the immunogenicity of an intradermal trivalent inactivated seasonal influenza vaccine, containing 15 microg of haemagglutinin per strain per 0.1 ml dose, is superior to that of a conventional intramuscular vaccine. Intradermal vaccine was given using an intradermal microinjection system. After the first vaccination, both vaccines satisfied the immunogenicity criteria for influenza vaccines for older adults set out in European regulatory guidelines, and geometric mean haemagglutination inhibition antibody titers and seroprotection rates were higher (statistically superior) with intradermal vaccination. Higher immune responses with intradermal vaccine were also observed after the 2nd and 3rd annual vaccinations. Both vaccines were well tolerated with similar systemic reactogenicity profiles. This intradermal influenza vaccine for older adults is a beneficial option for influenza protection, consistently enhancing antibody responses without compromising safety. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/19849996/Intradermal_influenza_vaccine_for_older_adults:_a_randomized_controlled_multicenter_phase_III_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(09)01561-8 DB - PRIME DP - Unbound Medicine ER -