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Immunogenicity and safety of Intanza(®)/IDflu(®) intradermal influenza vaccine in South Korean adults: a multicenter, randomized trial.

Authors
 Sang Hoon Han  ;  Jun Hee Woo  ;  Francoise Weber  ;  Woo Joo Kim  ;  Kyong Ran Peck  ;  Sang Il Kim  ;  Young Hwa Choi  ;  June Myung Kim 
Citation
 HUMAN VACCINES & IMMUNOTHERAPEUTICS, Vol.9(9) : 1971-1977, 2013 
Journal Title
 HUMAN VACCINES & IMMUNOTHERAPEUTICS 
ISSN
 2164-5515 
Issue Date
2013
MeSH
Adolescent ; Adult ; Aged ; Aged, 80 and over ; Antibodies, Viral/blood ; Drug-Related Side Effects and Adverse Reactions/epidemiology ; Drug-Related Side Effects and Adverse Reactions/pathology ; Erythema/chemically induced ; Erythema/epidemiology ; Female ; Hemagglutination Inhibition Tests ; Humans ; Influenza Vaccines/administration & dosage ; Influenza Vaccines/adverse effects* ; Influenza Vaccines/immunology* ; Influenza, Human/immunology ; Influenza, Human/prevention & control* ; Injections, Intradermal ; Male ; Middle Aged ; Pain/chemically induced ; Pain/epidemiology ; Pruritus/chemically induced ; Pruritus/epidemiology ; Republic of Korea ; Vaccines, Inactivated/administration & dosage ; Vaccines, Inactivated/adverse effects ; Vaccines, Inactivated/immunology ; Young Adult
Keywords
Influenza vaccine ; immunogenicity ; intradermal ; intramuscular ; safety
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).
Full Text
https://www.landesbioscience.com/journals/vaccines/article/25295/?nocache=1149202344
DOI
10.4161/hv.25295
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Kim, June Myung(김준명)
Han, Sang Hoon(한상훈) ORCID logo https://orcid.org/0000-0002-4278-5198
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/88265
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