Intradermal influenza vaccine for older adults: a randomized controlled multicenter phase III study

Vaccine. 2009 Dec 9;27(52):7304-12. doi: 10.1016/j.vaccine.2009.10.033. Epub 2009 Oct 20.

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.

Publication types

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

MeSH terms

  • Aged
  • Aged, 80 and over
  • Antibodies, Viral / blood
  • Female
  • Hemagglutinin Glycoproteins, Influenza Virus / immunology*
  • Humans
  • Immunization, Secondary
  • Influenza Vaccines / administration & dosage
  • Influenza Vaccines / adverse effects
  • Influenza Vaccines / immunology*
  • Influenza, Human / immunology
  • Influenza, Human / prevention & control*
  • Injections, Intradermal
  • Male
  • Middle Aged
  • Vaccines, Inactivated / administration & dosage
  • Vaccines, Inactivated / immunology

Substances

  • Antibodies, Viral
  • Hemagglutinin Glycoproteins, Influenza Virus
  • Influenza Vaccines
  • Vaccines, Inactivated