Immunogenicity and safety of an egg-based inactivated quadrivalent influenza vaccine (GC3110A) versus two inactivated trivalent influenza vaccines with alternate B strains

A phase Ⅲ randomized clinical trial in adults

Joon-Young Song, Jacob Lee, Heung Jeong Woo, Seong Heon Wie, Jin Soo Lee, Shin Woo Kim, Tae Hyong Kim, Sook In Jung, Ji Yun Noh, Wonseok Choi, Hee-Jin Cheong, Woo Joo Kim

Research output: Contribution to journalArticle

Abstract

Two antigenically distinct influenza B lineage viruses (Yamagata/Victoria) have been co-circulating globally since the mid-1980s. The quadrivalent influenza vaccine (QIV) may provide better protection against unpredictable B strains. We conducted a randomized, double-blind, phase III trial to evaluate the immunogenicity and safety of an egg-based inactivated, split-virion QIV (GC3110A). Subjects aged ≥ 19 years were randomized 2:1:1 to be vaccinated with QIV- GC3110A, trivalent influenza vaccine (TIV) containing the Yamagata lineage strain (TIV-Yamagata), or TIV containing the Victoria lineage strain (TIV-Victoria). Hemagglutination inhibition assays were performed 21 days post-vaccination. Solicited/unsolicited adverse events (AEs) were assessed within 21 days after vaccination, while serious AEs were reported up to six months after vaccination. A total of 1,299 were randomized to receive QIV-GC3110A (648 subjects), TIV-Yamagata (325 subjects), or TIV-Victoria (326 subjects). Compared to the TIVs, the QIV-GC3110A met the non-inferiority criteria for all four subtype/lineage strains with respect to the geometric mean titer (GMT) ratio and the difference of seroconversion rate. The safety profiles of QIV-GC3110A were consistent with those of TIV. In conclusion, QIV-GC3110A is safe, immunogenic, and comparable to strain-matched TIV.

Original languageEnglish
JournalHuman Vaccines and Immunotherapeutics
DOIs
Publication statusAccepted/In press - 2018 Jan 1

Fingerprint

Influenza Vaccines
Ovum
Randomized Controlled Trials
Safety
Victoria
Vaccination
Influenza B virus
Hemagglutination
Virion

Keywords

  • Inactivated quadrivalent influenza vaccine
  • Influenza B
  • victoria lineage
  • yamagata lineage

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Pharmacology

Cite this

@article{6b6bd16070024e71a201c24dfcccd67e,
title = "Immunogenicity and safety of an egg-based inactivated quadrivalent influenza vaccine (GC3110A) versus two inactivated trivalent influenza vaccines with alternate B strains: A phase Ⅲ randomized clinical trial in adults",
abstract = "Two antigenically distinct influenza B lineage viruses (Yamagata/Victoria) have been co-circulating globally since the mid-1980s. The quadrivalent influenza vaccine (QIV) may provide better protection against unpredictable B strains. We conducted a randomized, double-blind, phase III trial to evaluate the immunogenicity and safety of an egg-based inactivated, split-virion QIV (GC3110A). Subjects aged ≥ 19 years were randomized 2:1:1 to be vaccinated with QIV- GC3110A, trivalent influenza vaccine (TIV) containing the Yamagata lineage strain (TIV-Yamagata), or TIV containing the Victoria lineage strain (TIV-Victoria). Hemagglutination inhibition assays were performed 21 days post-vaccination. Solicited/unsolicited adverse events (AEs) were assessed within 21 days after vaccination, while serious AEs were reported up to six months after vaccination. A total of 1,299 were randomized to receive QIV-GC3110A (648 subjects), TIV-Yamagata (325 subjects), or TIV-Victoria (326 subjects). Compared to the TIVs, the QIV-GC3110A met the non-inferiority criteria for all four subtype/lineage strains with respect to the geometric mean titer (GMT) ratio and the difference of seroconversion rate. The safety profiles of QIV-GC3110A were consistent with those of TIV. In conclusion, QIV-GC3110A is safe, immunogenic, and comparable to strain-matched TIV.",
keywords = "Inactivated quadrivalent influenza vaccine, Influenza B, victoria lineage, yamagata lineage",
author = "Joon-Young Song and Jacob Lee and Woo, {Heung Jeong} and Wie, {Seong Heon} and Lee, {Jin Soo} and Kim, {Shin Woo} and Kim, {Tae Hyong} and Jung, {Sook In} and Noh, {Ji Yun} and Wonseok Choi and Hee-Jin Cheong and Kim, {Woo Joo}",
year = "2018",
month = "1",
day = "1",
doi = "10.1080/21645515.2018.1536589",
language = "English",
journal = "Human Vaccines and Immunotherapeutics",
issn = "2164-5515",
publisher = "Landes Bioscience",

}

TY - JOUR

T1 - Immunogenicity and safety of an egg-based inactivated quadrivalent influenza vaccine (GC3110A) versus two inactivated trivalent influenza vaccines with alternate B strains

T2 - A phase Ⅲ randomized clinical trial in adults

AU - Song, Joon-Young

AU - Lee, Jacob

AU - Woo, Heung Jeong

AU - Wie, Seong Heon

AU - Lee, Jin Soo

AU - Kim, Shin Woo

AU - Kim, Tae Hyong

AU - Jung, Sook In

AU - Noh, Ji Yun

AU - Choi, Wonseok

AU - Cheong, Hee-Jin

AU - Kim, Woo Joo

PY - 2018/1/1

Y1 - 2018/1/1

N2 - Two antigenically distinct influenza B lineage viruses (Yamagata/Victoria) have been co-circulating globally since the mid-1980s. The quadrivalent influenza vaccine (QIV) may provide better protection against unpredictable B strains. We conducted a randomized, double-blind, phase III trial to evaluate the immunogenicity and safety of an egg-based inactivated, split-virion QIV (GC3110A). Subjects aged ≥ 19 years were randomized 2:1:1 to be vaccinated with QIV- GC3110A, trivalent influenza vaccine (TIV) containing the Yamagata lineage strain (TIV-Yamagata), or TIV containing the Victoria lineage strain (TIV-Victoria). Hemagglutination inhibition assays were performed 21 days post-vaccination. Solicited/unsolicited adverse events (AEs) were assessed within 21 days after vaccination, while serious AEs were reported up to six months after vaccination. A total of 1,299 were randomized to receive QIV-GC3110A (648 subjects), TIV-Yamagata (325 subjects), or TIV-Victoria (326 subjects). Compared to the TIVs, the QIV-GC3110A met the non-inferiority criteria for all four subtype/lineage strains with respect to the geometric mean titer (GMT) ratio and the difference of seroconversion rate. The safety profiles of QIV-GC3110A were consistent with those of TIV. In conclusion, QIV-GC3110A is safe, immunogenic, and comparable to strain-matched TIV.

AB - Two antigenically distinct influenza B lineage viruses (Yamagata/Victoria) have been co-circulating globally since the mid-1980s. The quadrivalent influenza vaccine (QIV) may provide better protection against unpredictable B strains. We conducted a randomized, double-blind, phase III trial to evaluate the immunogenicity and safety of an egg-based inactivated, split-virion QIV (GC3110A). Subjects aged ≥ 19 years were randomized 2:1:1 to be vaccinated with QIV- GC3110A, trivalent influenza vaccine (TIV) containing the Yamagata lineage strain (TIV-Yamagata), or TIV containing the Victoria lineage strain (TIV-Victoria). Hemagglutination inhibition assays were performed 21 days post-vaccination. Solicited/unsolicited adverse events (AEs) were assessed within 21 days after vaccination, while serious AEs were reported up to six months after vaccination. A total of 1,299 were randomized to receive QIV-GC3110A (648 subjects), TIV-Yamagata (325 subjects), or TIV-Victoria (326 subjects). Compared to the TIVs, the QIV-GC3110A met the non-inferiority criteria for all four subtype/lineage strains with respect to the geometric mean titer (GMT) ratio and the difference of seroconversion rate. The safety profiles of QIV-GC3110A were consistent with those of TIV. In conclusion, QIV-GC3110A is safe, immunogenic, and comparable to strain-matched TIV.

KW - Inactivated quadrivalent influenza vaccine

KW - Influenza B

KW - victoria lineage

KW - yamagata lineage

UR - http://www.scopus.com/inward/record.url?scp=85057537109&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85057537109&partnerID=8YFLogxK

U2 - 10.1080/21645515.2018.1536589

DO - 10.1080/21645515.2018.1536589

M3 - Article

JO - Human Vaccines and Immunotherapeutics

JF - Human Vaccines and Immunotherapeutics

SN - 2164-5515

ER -