Publisher Full Text
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.
Links
MeSH
Pub Type(s)
Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
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 - 2020/2/27/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 - https://www.tandfonline.com/doi/full/10.1080/21645515.2018.1536589
DB - PRIME
DP - Unbound Medicine
ER -
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