Abstract
VaxigripTetra® (Sanofi Pasteur, Lyon, France) is a quadrivalent split-virion inactivated influenza vaccine (IIV4) containing two B-lineage strains approved in the European Union and Taiwan in 2016 for individuals ≥ 3 years of age. Here, we describe an observer-blind, randomized, controlled, multicenter trial study evaluating the immunogenicity and safety of the Northern Hemisphere 2015–2016 formulations of IIV4 and the licensed split-virion trivalent inactivated influenza vaccine (IIV3) in the Republic of Korea (ClinicalTrials.gov no. NCT02550197). The study included 300 Korean adults 18–60 years of age randomized 2:1 to receive a single injection of IIV4 or IIV3. For each of the four vaccine strains in IIV4, 21 days after vaccination, geometric mean post-/pre-vaccination ratios of hemagglutination inhibition titers were ≥ 3.97. Seroconversion/significant increases rates were ≥ 40% for all but the A/H1N1 strain, for which the rate was 39.7%. Results were similar for the three strains in IIV3. For the additional B-lineage strain not in IIV3 (Victoria), hemagglutination inhibition antibody titers were higher for IIV4 than for IIV3. Solicited reactions and adverse events were similar between IIV4 and IIV3, and no serious adverse events or new safety signals were detected. These results confirm the robust immunogenicity and acceptable safety of IIV4 in adults 18–60 years of age and show that including a second B-lineage strain should provide broader protection against B-strain influenza without affecting vaccine safety or the immunogenicity of other three vaccine strains.
| Original language | English |
|---|---|
| Pages (from-to) | 1-6 |
| Number of pages | 6 |
| Journal | Human Vaccines and Immunotherapeutics |
| DOIs | |
| Publication status | Accepted/In press - 2017 Nov 15 |
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Keywords
- adults
- inactivated influenza vaccine
- quadrivalent influenza vaccine
- Republic of Korea
ASJC Scopus subject areas
- Immunology and Allergy
- Immunology
- Pharmacology
Cite this
Immunogenicity and safety of a split-virion quadrivalent influenza vaccine in adults 18–60 years of age in the Republic of Korea. / Choi, Wonseok; Noh, Ji Yun; Lee, Jacob; Choi, Jun Yong; Lee, Jin Soo; Kim, Moo Soo; Kim, Hee Soo; Bang, Joon; Lavis, Nathalie; Kim, Woo Joo.
In: Human Vaccines and Immunotherapeutics, 15.11.2017, p. 1-6.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Immunogenicity and safety of a split-virion quadrivalent influenza vaccine in adults 18–60 years of age in the Republic of Korea
AU - Choi, Wonseok
AU - Noh, Ji Yun
AU - Lee, Jacob
AU - Choi, Jun Yong
AU - Lee, Jin Soo
AU - Kim, Moo Soo
AU - Kim, Hee Soo
AU - Bang, Joon
AU - Lavis, Nathalie
AU - Kim, Woo Joo
PY - 2017/11/15
Y1 - 2017/11/15
N2 - VaxigripTetra® (Sanofi Pasteur, Lyon, France) is a quadrivalent split-virion inactivated influenza vaccine (IIV4) containing two B-lineage strains approved in the European Union and Taiwan in 2016 for individuals ≥ 3 years of age. Here, we describe an observer-blind, randomized, controlled, multicenter trial study evaluating the immunogenicity and safety of the Northern Hemisphere 2015–2016 formulations of IIV4 and the licensed split-virion trivalent inactivated influenza vaccine (IIV3) in the Republic of Korea (ClinicalTrials.gov no. NCT02550197). The study included 300 Korean adults 18–60 years of age randomized 2:1 to receive a single injection of IIV4 or IIV3. For each of the four vaccine strains in IIV4, 21 days after vaccination, geometric mean post-/pre-vaccination ratios of hemagglutination inhibition titers were ≥ 3.97. Seroconversion/significant increases rates were ≥ 40% for all but the A/H1N1 strain, for which the rate was 39.7%. Results were similar for the three strains in IIV3. For the additional B-lineage strain not in IIV3 (Victoria), hemagglutination inhibition antibody titers were higher for IIV4 than for IIV3. Solicited reactions and adverse events were similar between IIV4 and IIV3, and no serious adverse events or new safety signals were detected. These results confirm the robust immunogenicity and acceptable safety of IIV4 in adults 18–60 years of age and show that including a second B-lineage strain should provide broader protection against B-strain influenza without affecting vaccine safety or the immunogenicity of other three vaccine strains.
AB - VaxigripTetra® (Sanofi Pasteur, Lyon, France) is a quadrivalent split-virion inactivated influenza vaccine (IIV4) containing two B-lineage strains approved in the European Union and Taiwan in 2016 for individuals ≥ 3 years of age. Here, we describe an observer-blind, randomized, controlled, multicenter trial study evaluating the immunogenicity and safety of the Northern Hemisphere 2015–2016 formulations of IIV4 and the licensed split-virion trivalent inactivated influenza vaccine (IIV3) in the Republic of Korea (ClinicalTrials.gov no. NCT02550197). The study included 300 Korean adults 18–60 years of age randomized 2:1 to receive a single injection of IIV4 or IIV3. For each of the four vaccine strains in IIV4, 21 days after vaccination, geometric mean post-/pre-vaccination ratios of hemagglutination inhibition titers were ≥ 3.97. Seroconversion/significant increases rates were ≥ 40% for all but the A/H1N1 strain, for which the rate was 39.7%. Results were similar for the three strains in IIV3. For the additional B-lineage strain not in IIV3 (Victoria), hemagglutination inhibition antibody titers were higher for IIV4 than for IIV3. Solicited reactions and adverse events were similar between IIV4 and IIV3, and no serious adverse events or new safety signals were detected. These results confirm the robust immunogenicity and acceptable safety of IIV4 in adults 18–60 years of age and show that including a second B-lineage strain should provide broader protection against B-strain influenza without affecting vaccine safety or the immunogenicity of other three vaccine strains.
KW - adults
KW - inactivated influenza vaccine
KW - quadrivalent influenza vaccine
KW - Republic of Korea
UR - http://www.scopus.com/inward/record.url?scp=85034250766&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85034250766&partnerID=8YFLogxK
U2 - 10.1080/21645515.2017.1381808
DO - 10.1080/21645515.2017.1381808
M3 - Article
C2 - 28933625
AN - SCOPUS:85034250766
SP - 1
EP - 6
JO - Human Vaccines and Immunotherapeutics
JF - Human Vaccines and Immunotherapeutics
SN - 2164-5515
ER -