Immunogenicity and safety of Intanza®/IDflu® intradermal influenza vaccine in South Korean adults

A multicenter, randomized trial

Sang Hoon Han, Jun Hee Woo, Francoise Weber, Woo Joo Kim, Kyong Ran Peck, Sang Il Kim, Young Hwa Choi, June Myung Kim

Research output: Contribution to journalArticle

8 Citations (Scopus)

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).

Original languageEnglish
Pages (from-to)1971-1977
Number of pages7
JournalHuman Vaccines and Immunotherapeutics
Volume9
Issue number9
DOIs
Publication statusPublished - 2013 Sep 1

Fingerprint

Influenza Vaccines
Multicenter Studies
Vaccines
Safety
France
Vaccination
Hemagglutination
Erythema
Pruritus
Human Influenza
Age Groups
Pain
Injections
Seroconversion
Therapeutics

Keywords

  • Immunogenicity
  • Influenza vaccine
  • Intradermal
  • Intramuscular
  • Safety

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Pharmacology

Cite this

Immunogenicity and safety of Intanza®/IDflu® intradermal influenza vaccine in South Korean adults : A multicenter, randomized trial. / Han, Sang Hoon; Woo, Jun Hee; Weber, Francoise; Kim, Woo Joo; Peck, Kyong Ran; Kim, Sang Il; Choi, Young Hwa; Kim, June Myung.

In: Human Vaccines and Immunotherapeutics, Vol. 9, No. 9, 01.09.2013, p. 1971-1977.

Research output: Contribution to journalArticle

Han, Sang Hoon ; Woo, Jun Hee ; Weber, Francoise ; Kim, Woo Joo ; Peck, Kyong Ran ; Kim, Sang Il ; Choi, Young Hwa ; Kim, June Myung. / Immunogenicity and safety of Intanza®/IDflu® intradermal influenza vaccine in South Korean adults : A multicenter, randomized trial. In: Human Vaccines and Immunotherapeutics. 2013 ; Vol. 9, No. 9. pp. 1971-1977.
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AB - 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).

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