title: Immunogenicity and safety of Intanza(®)/IDflu(®) intradermal influenza vaccine in South Korean adults: a multicenter, randomized trial.
abstract: Intanza(®)/IDflu(®) (Sanofi Pasteur, Lyon, France) is an intradermal inactivated trivalent influenza vaccine developed as an alternative to intramuscular influenza vaccine. The objective of this study was to confirm the immunogenicity and safety of Intanza/IDflu in South Korean adults. In a phase IV multicenter trial, South Korean adults 18-59 y old (n = 120) and ≥ 60 y old (n = 120) were randomized 1:1 to receive a single dose of Intanza/IDflu (9 µg for 18-59 y, 15 µg for ≥ 60 y) or trivalent intramuscular vaccine (Vaxigrip(®) 15 µg, Sanofi Pasteur, Lyon, France). Blood was collected on pre-vaccination (day 0) and on day 21. Hemagglutination inhibition titers, seroprotection rates and seroconversion rates were determined on day 21. Geometric mean titers, seroprotection and seroconversion rates were similar between the intradermal and intramuscular vaccines in both age groups for all three vaccine strains (A/H1N1, A/H3N2 and B). Both vaccines met Committee for Medicinal Products for Human Use criteria for all three strains. Solicited systemic reactions of the intradermal groups were generally mild, transient, and similar to those of the intramuscular groups. Solicited injection site reactions were more frequent in the intradermal groups but were mostly mild, transient, and consisted mainly of pain, erythema, and pruritus. No treatment-related serious adverse events or other safety concerns were reported. These results confirm that Intanza/IDflu is an effective and well-tolerated alternative to IM influenza vaccination. (Clinicaltrials.gov NCT ID: NCT01215669).
authors.affiliation: Department of Internal Medicine; Yonsei University College of Medicine; Seoul, Korea.
authors.forename: Sang
authors.initials: S
authors.lastname: Hoon Han
authors.forename: Jun
authors.initials: J
authors.lastname: Hee Woo
authors.forename: Francoise
authors.initials: F
authors.lastname: Weber
authors.forename: Woo
authors.initials: W
authors.lastname: Joo Kim
authors.forename: Kyong
authors.initials: K
authors.lastname: Ran Peck
authors.forename: Sang
authors.initials: S
authors.lastname: Il Kim
authors.forename: Young
authors.initials: Y
authors.lastname: Hwa Choi
authors.forename: June
authors.initials: J
authors.lastname: Myung Kim
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000914:Antibodies, Viral / Q000097:blood; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D004890:Erythema / Q000139:chemically induced / Q000453:epidemiology; D005260:Female; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D007251:Influenza, Human / Q000276:immunology / Q000517:prevention & control*; D007271:Injections, Intradermal; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000139:chemically induced / Q000453:epidemiology; D011537:Pruritus / Q000139:chemically induced / Q000453:epidemiology; D056910:Republic of Korea; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D055815:Young Adult
chemical_list: D000914:Antibodies, Viral; D007252:Influenza Vaccines; D015164:Vaccines, Inactivated
keywords: Influenza vaccine; immunogenicity; intradermal; intramuscular; safety