NCT03657719

A Study to Evaluate the Safety and Efficacy(Immunogenicity) of GC3114 in Elderly Healthy Subjects

Open-labeled(Part 1), Single-group(Part 2), Randomized(Part 2), Double-blind(Part 2), Active-controlled(Part 2) Pharse II Clinical Trial to Evaluate Safety and Efficacy(Immunogenicity) of GC3114 in Elderly Healthy Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Green Cross Corporation · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

Elderly healthy subjects will be once administered GC3114A(High-dose Quadrivalent influenza vaccine) or GCFLU Quadrivalent Pre-filled syringe inj..

Detailed description

Elderly healthy subjects will be once administered GC3114A(High-dose Quadrivalent influenza vaccine) or GCFLU Quadrivalent Pre-filled syringe inj.. Safety and immunological efficacy will be evaluated.

Conditions

• Influenza, Human

Interventions

Type	Name	Description
BIOLOGICAL	GC3114	High-dose Quadrivalent influenza vaccine
BIOLOGICAL	GCFLU Quadrivalent	Quadrivalent influenza vaccine

Timeline

• Start date: 2018-10-01
• Primary completion: 2018-12-13
• Completion: 2018-12-13
• First posted: 2018-09-05
• Last updated: 2019-01-04

Locations

1 site across 1 country: South Korea