Trials / Unknown
UnknownNCT02658409
A Multicenter, Double-blind, Parallel, Non-inferiority, Phase III Study
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel, Non-inferiority, Phase III Study to Investigate the Efficacy (Immunogenicity) and Safety of GC3106 (Quadrivalent Cell-culture Based Influenza Vaccine)
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,630 (actual)
- Sponsor
- Green Cross Corporation · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Accepted
Summary
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel, Non-inferiority, Phase III Study.
Detailed description
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel, Non-inferiority, Phase III Study to Investigate the Efficacy (Immunogenicity) and Safety of GC3106 (quadrivalent cell-culture based influenza vaccine) after Intramuscular Administration in Healthy Subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | GC3106(quadrivalent cell-culture based influenza vaccine) | GC3106(quadrivalent),0.5ml, intramuscular, a single dosing at Day 1 |
| BIOLOGICAL | Fluarix™tetra Syringe Inj.(quadrivalent influenza vaccine) | Fluarix™tetra Syringe Inj., 0.5ml, intramuscular, a single dosing at Day 1 |
Timeline
- Start date
- 2015-11-01
- Primary completion
- 2015-11-01
- First posted
- 2016-01-18
- Last updated
- 2016-02-26
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT02658409. Inclusion in this directory is not an endorsement.