Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Phase III Non-inferiority Study of GC3106 Quadrivalent Cell-culture Influenza Vaccine in Healthy Subjects
KCT0001902Phase 3
Key facts
- Status
- Completed
- Start
- Nov 2015
- Countries
- 1
- Sponsor
- Ministry of Health & Welfare
- Modality
- Vaccines & Immunotherapeutics
- Drugs
- GC3106
- Conditions
- influenza
01
Overview
Phase 3, randomised, double-blind trial of GC3106 in influenza (2 arms), sponsored by Ministry of Health & Welfare. Primary endpoint: Immunogenicity non-inferiority. Started Nov 2015; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
GC3106 arm
Subjects receive the GC3106 quadrivalent cell-culture based influenza vaccine via intramuscular injection.
Active comparator arm
Subjects receive an established quadrivalent influenza vaccine as active control via intramuscular injection.
03
Who it enrols
Healthy Korean adult volunteers eligible for influenza vaccination, excluding pregnant women and requiring appropriate contraception as standard for vaccine trials.
04
Endpoints
Primary
Immunogenicity non-inferiority
Secondary
Safety and tolerability
Beyond the preview
Go deeper on KCT0001902.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on KCT0001902.