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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.
Hum Vaccin Immunother. 2019; 15(3):710-716.HV

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.

Authors+Show Affiliations

a Division of Infectious Diseases, Department of Internal Medicine , Korea University College of Medicine1 , Seoul , Korea.b Division of Infectious Diseases, Department of Internal Medicine, Kangnam Sacred Heart Hospital , Hallym University College of Medicine , Seoul , Korea.c Division of Infectious Diseases, Department of Internal Medicine, Dongtan Sacred Heart Hospital , Hallym University College of Medicine , Hwasung , Korea.d Division of Infectious Diseases, Department of Internal Medicine , Catholic University Medical College, St. Vincent's Hospital , Suwon , Korea.e Division of Infectious Diseases, Department of Internal Medicine , Inha University College of Medicine , Incheon , Korea.f Division of Infectious Diseases, Department of Internal Medicine , Kyungpook National University School of Medicine , Daegu , Korea.g Division of Infectious Diseases, Department of Internal Medicine , Soon Chun Hyang University Hospital, Soon Chun Hyang University College of Medicine , Seoul , Korea.h Division of Infectious Diseases, Department of Internal Medicine, Chonnam National University Medical School , Chonnam National University Hospital , Gwangju , Korea.a Division of Infectious Diseases, Department of Internal Medicine , Korea University College of Medicine1 , Seoul , Korea.a Division of Infectious Diseases, Department of Internal Medicine , Korea University College of Medicine1 , Seoul , Korea.a Division of Infectious Diseases, Department of Internal Medicine , Korea University College of Medicine1 , Seoul , Korea.a Division of Infectious Diseases, Department of Internal Medicine , Korea University College of Medicine1 , Seoul , Korea.

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

30396317

Citation

Song, Joon Young, et al. "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." Human Vaccines & Immunotherapeutics, vol. 15, no. 3, 2019, pp. 710-716.
Song JY, Lee J, Woo HJ, et al. 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. Hum Vaccin Immunother. 2019;15(3):710-716.
Song, J. Y., Lee, J., Woo, H. J., Wie, S. H., Lee, J. S., Kim, S. W., Kim, T. H., Jung, S. I., Noh, J. Y., Choi, W. S., Cheong, H. J., & Kim, W. J. (2019). 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. Human Vaccines & Immunotherapeutics, 15(3), 710-716. https://doi.org/10.1080/21645515.2018.1536589
Song JY, et al. 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. Hum Vaccin Immunother. 2019;15(3):710-716. PubMed PMID: 30396317.
* Article titles in AMA citation format should be in sentence-case
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: 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,Won Suk, AU - Cheong,Hee Jin, AU - Kim,Woo Joo, Y1 - 2018/11/15/ PY - 2018/11/7/pubmed PY - 2018/11/7/medline PY - 2018/11/7/entrez KW - Inactivated quadrivalent influenza vaccine KW - Influenza B KW - victoria lineage KW - yamagata lineage SP - 710 EP - 716 JF - Human vaccines & immunotherapeutics JO - Hum Vaccin Immunother VL - 15 IS - 3 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. SN - 2164-554X UR - https://www.unboundmedicine.com/medline/citation/30396317/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_ L2 - http://www.tandfonline.com/doi/full/10.1080/21645515.2018.1536589 DB - PRIME DP - Unbound Medicine ER -
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