Superior immunogenicity profile of the new intradermal influenza vaccine compared to the standard subcutaneous vaccine in subjects 65 years and older: A randomized controlled phase III study

• Published in: Vaccine Vol. 33; no. 48; pp. 6650 - 6658
• Main Authors: Arakane, Ryo, Annaka, Ryosuke, Takahama, Akiko, Ishida, Katsuyasu, Yoshiike, Michiharu, Nakayama, Tetsuo, Takeshita, Fumihiko
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Ltd 27.11.2015; Elsevier BV; Elsevier Limited
• Subjects: Aged; Aged, 80 and over; Allergy and Immunology; Antibodies, Viral; Antibodies, Viral - blood; blood serum; burden of disease; Clinical trial; Clinical trials; Double-Blind Method; Drug dosages; elderly; Female; hemagglutination; Hemagglutination Inhibition Tests; Humans; Illnesses; Immunization; Immunogenicity; Immunology and Microbiology(all); Infectious Diseases; Influenza; Influenza Vaccines; Influenza Vaccines - administration & dosage; Influenza Vaccines - immunology; Influenza, Human; Influenza, Human - prevention & control; Injection; injection site; Injections, Intradermal; Injections, Subcutaneous; Intradermal vaccine; Male; Molecular Medicine; Mortality; Novel device; Older people; Public Health, Environmental and Occupational Health; risk; seroconversion; Treatment Outcome; vaccination; Vaccines; veterinary(all); Young adults; Japan; SCR; AE; GMTR; GMT; Novel device; SC; HAI; SPR; Influenza; CHMP; HA; Clinical trial; ID; Intradermal vaccine; hemagglutination inhibition; The Committee for Medicinal Products for Human Use; hemagglutinin; ratio of GMT; adverse event; seroprotection ratio; intradermal; subcutaneous; seroconversion ratio; geometrical mean titer

Although the elderly are at high risk for influenza, the immunogenicity in the elderly is lower than that in younger adults. We developed the new type of seasonal influenza vaccine with the novel intradermal (ID) injection system. In the previous exploratory phase I/II study of the ID vaccine with a...