Safety and Immunogenicity of an Egg-Cultivated Quadrivalent Inactivated Split-virion Influenza Vaccine (GC3110A) in Healthy Korean Children: a Randomized, Double-blinded, Active-controlled Phase III Study

Abstract

BackgroundThe frequency with which the 2 B lineages have been found to cocirculate in a season has been on the rise, which has spurred the need for a quadrivalent influenza vaccine (QIV) to protect against both B lineages. The World Health Organization (WHO) recommended that QIV include both B lineages beginning in the 2013–2014 flu season. This study was conducted to evaluate the immunogenicity and safety of an egg-cultivated QIV in healthy Korean children and adolescents aged ≥ 6 months to < 19 years.MethodsA total of 528 subjects were randomized 4:1 to receive either a QIV (GC3110A) or a trivalent influenza vaccine. Hemagglutination inhibition antibody responses were assessed 28 days after the last dose. Safety was also evaluated.ResultsThe proportion of subjects in the GC3110A group who achieved seroconversion was confirmed to exceed 40% across all age groups. The proportion of subjects aged ≥ 6 months to < 3 years in the GC3110A group who achieved seroprotection failed to meet the Ministry of Food and Drug Safety (MFDS) standard of 70%. Potential causes may include the small number of subjects, as well as the small dosage. However, results pertaining to the other age groups satisfied the MFDS standard. The safety profile was also comparable to that of the control.ConclusionThe new quadrivalent split influenza vaccine may offer broader protection to children and adolescents aged ≥ 3 years to < 19 years of age against both influenza B lineages than the existing trivalent influenza vaccines.Trial RegistrationClinicalTrials.gov Identifier: NCT02541253

Immunogenicity and safety of quadrivalent inactivated influenza vaccine in children aged 6 to 35 months: A systematic review and meta-analysis

“… Source Country Type of study Total number of subjects aged 6 to 35 months Study period Vaccine strains in test group Vaccine strains in control group Vaccine manufacturer Clinical Trial Registry No. Eun et al 28 Korean Phase II, double-blind, multi-center 135 2014.09–2016.06 15 μg hemagglutinin per strain A/Christchurch/16/2010 (A/H1N1) A/Texas/50/2012 (A/H3N2) B/Massachusetts/2/2012(B/Yamagata) B/Brisbane/60/2008 (B/Victoria) 15 μg or 7.5 μg hemagglutinin per strain A/Christchurch/16/2010 (A/H1N1) A/Texas/50/2012 (A/H3N2) B/Brisbane/60/2008 (B/Victoria) SK Bioscience, Novartis Vaccine and Diagnostics Srl NA Lee et al 29 Korean Phase III, double-blind, multi-center 137 2015.10–2016.06 7.5 μg hemagglutinin per strain A/California/7/2009 (A/H1N1) A/Switzerland/9715293/2013 (A/H3N2) B/Phuket/3073/2013(B/Yamagata) B/Brisbane/60/2008 (B/Victoria) 15 μg hemagglutinin per strain A/California/7/2009 (A/H1N1) A/Switzerland/9715293/2013(A/H3N2) B/Phuket/3073/2013(B/Yamagata) Green Cross Corporation NCT02541253 Langley et al 30 Canada, Dominican, Honduras Phase II, double-blind, multi-center 571 2012.11–2013.06 15 μg hemagglutinin per strain A/California/7/2009(A/H1N1) A/Victoria/361/2011(A/H3N2) B/Brisbane/60/2008(B/Victoria) B/Hubei-Wujiagang/158/2009(B/Yamagata) 15 μg hemagglutinin per strain A/California/7/2009(A/H1N1) A/Victoria/361/2011(A/H3N2) B/Massachusetts/2/2012/(B/Yamagata) GlaxoSmithKline NCT01711736 Wang et al 31 ...…”

Evaluation of Waning Immunity at 6 Months after Both Trivalent and Quadrivalent Influenza Vaccination in Korean Children Aged 6–35 Months

“…Our results did not include pre- and post-vaccination data, thus it may be difficult to discriminate whether antibody titers against influenza B were low even immediately after vaccination, or whether antibodies were fully produced but rapidly degraded. Previous studies have shown that immunity was lower against influenza B strains than against A strains 91014151617. Kang, et al9 reported that the seroprotection rates at 1 month, 6 months, and 12 months after vaccination against influenza B were 65.8%, 26.5% and 10.0%, respectively, in 6–35-month-old children.…”

Immunogenicity and safety of the first indigenously developed Indian tetravalent influenza vaccine (split virion) in healthy children (6 months to 17 years of age): a randomized, multicenter, phase III clinical trial

“…This statistical approach was in line with the published literature. [12][13][14][15] The seroconversion and seroprotection rates and GMTs in the two groups stratified by age (cohort 1: 9-17 years; cohort 2: 3-8 years, and cohort 3: 6-35 months) were also calculated.…”