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.
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Authors | Leilani Sanchez, Osamu Matsuoka, Satoshi Inoue, Takahiro Inoue, Ya Meng, Takahiro Nakama, Kumiko Kato, Aseem Pandey, Lee-Jah Chang |
Journal | Human vaccines & immunotherapeutics
(Hum Vaccin Immunother)
Vol. 16
Issue 4
Pg. 858-866
(04 02 2020)
ISSN: 2164-554X [Electronic] United States |
PMID | 31634025
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antibodies, Viral
- Influenza Vaccines
- Vaccines, Inactivated
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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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