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Immunogenicity and safety of high-dose quadrivalent influenza vaccine in Japanese adults ≥65 years of age: a randomized controlled clinical trial.

Abstract
A trivalent high-dose inactivated influenza vaccine has been licensed in healthy adults ≥65 years of age and provides better protection against influenza infection and related complications than trivalent standard-dose vaccine. This phase I/II clinical trial (NCT03233217), conducted at two sites in Japan, examined the safety and immunogenicity of a quadrivalent formulation of the high-dose inactivated influenza vaccine (IIV4-HD). Healthy adults ≥65 years of age were randomized to receive IIV4-HD by intramuscular injection (n = 60), IIV4-HD by subcutaneous injection (n = 60), or a quadrivalent standard-dose inactivated influenza vaccine (IIV4-SD) by subcutaneous injection (n = 55). Irrespective of administration route, post-vaccination (day 28-35) hemagglutination inhibition geometric mean titers and seroconversion rates were higher for IIV4-HD than for IIV4-SD. Hemagglutination inhibition geometric mean titers and seroconversion rates were also higher for intramuscular than subcutaneous administration of IIV4-HD. Solicited reactions were more common in participants who received IIV4-HD administered subcutaneously than in those who received IIV4-HD administered intramuscularly or IIV4-SD administered subcutaneously. Unsolicited adverse events were similar between the vaccine groups, and no safety signals were detected. This study showed that IIV4-HD administered by either intramuscular or subcutaneous injection was well tolerated and highly immunogenic in healthy Japanese adults ≥65 years of age. Although this study was descriptive, the results add to the evidence that high-dose inactivated influenza vaccines are more immunogenic than standard-dose vaccines in this age group and that intramuscular administration provides greater immunogenicity and lower reactogenicity than subcutaneous administration.
AuthorsLeilani Sanchez, Osamu Matsuoka, Satoshi Inoue, Takahiro Inoue, Ya Meng, Takahiro Nakama, Kumiko Kato, Aseem Pandey, Lee-Jah Chang
JournalHuman vaccines & immunotherapeutics (Hum Vaccin Immunother) Vol. 16 Issue 4 Pg. 858-866 (04 02 2020) ISSN: 2164-554X [Electronic] United States
PMID31634025 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Antibodies, Viral
  • Influenza Vaccines
  • Vaccines, Inactivated
Topics
  • Adult
  • Antibodies, Viral
  • Hemagglutination Inhibition Tests
  • Humans
  • Immunogenicity, Vaccine
  • Influenza Vaccines (adverse effects)
  • Influenza, Human (prevention & control)
  • Japan
  • Vaccines, Inactivated (adverse effects)

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