Drug intelligence / Profile preview

GC3110A

Development stage
Unknown
Lead developer
GC Biopharma
Modality
Whole Inactivated Vaccines → Inactivated Vaccines → Prophylactic Vaccines → Vaccines & Immunotherapeutics
Administration
Intramuscular
01

Overview

GC3110A is a quadrivalent inactivated influenza vaccine (QIV) developed by Green Cross Corporation. It's an egg-cultivated, split-virion vaccine designed to provide broader protection against influenza by including antigens from both B virus lineages (Yamagata and Victoria) in addition to the standard A/H1N1 and A/H3N2 strains. ## Composition and Formulation Each 0.5 mL dose of GC3110A contains 15 μg of each of the four purified hemagglutinin antigens (60 μg total). The vaccine is formulated with phosphate buffer containing sodium chloride, potassium chloride, disodium hydrogen phosphate dehydrate, and potassium dihydrogen phosphate. ## Clinical Development GC3110A has undergone extensive clinical testing: - A phase 3 trial in adults demonstrated that GC3110A met non-inferiority criteria compared to trivalent influenza vaccines (TIVs) for all four influenza strains regarding geometric mean titer ratio and seroconversion rate difference. - Another phase 3 trial in children aged 6-35 months showed that GC3110A met both primary and secondary immunogenicity endpoints. The study vaccine group demonstrated significantly higher immunity for the additional B/Yamagata strain compared to the control TIV. - Safety profiles were consistent with those of trivalent influenza vaccines across all age groups studied. ## Regulatory Status The vaccine has been approved and is currently in use in Korea. It appears to be under regulatory review in other countries, including Egypt. ## Advantages The main advantage of GC3110A over trivalent vaccines is its broader protection against influenza B viruses. By including both B/Yamagata and B/Victoria lineages, it addresses the limitation of TIVs which offer reduced protection when both B lineages co-circulate or when there's a vaccine mismatch between the predominant circulating B strain and the WHO-recommended strain. The development of GC3110A represents an advancement in influenza vaccination strategy, potentially reducing the burden of influenza by providing broader coverage against circulating strains.

02

Targets

HA (Hemagglutinin)

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