A Study to Evaluate the Safety and Efficacy(Immunogenicit... | NCT03657719

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

NCT03657719

Sponsor

Green Cross Corporation

Status

Completed

Last Update Posted

Jan 4, 2019Actual

Enrollment

105Actual

Phase

Phase 2

Conditions

Influenza, Human

Interventions

GC3114
GCFLU Quadrivalent

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2018Actual

Primary Completion Date

Dec 13, 2018Actual

Completion Date

Dec 13, 2018Actual

First Submitted Date

Aug 27, 2018

First Submission Date that Met QC Criteria

Sep 1, 2018

First Posted Date

Sep 5, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 3, 2019

Last Update Posted Date

Jan 4, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

105Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GC3114	Experimental	Pre-filled syringe inj., 0.5ml, Once, IM	Biological: GC3114
Active Comparator: GCFLU Quadrivalent	Active Comparator	Pre-filled syringe inj., 0.5ml, Once, IM	Biological: GCFLU Quadrivalent

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GC3114	Biological	High-dose Quadrivalent influenza vaccine	GC3114

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse Event	Solicited/Unsolicited Adverse Event	for 7 days from Day0/during study period

Secondary Outcomes

Measure	Description	Time Frame
Percentage of participants achieving pre-defined Seroconversion Before and following vaccination	Seroconversion rate (SCR)	Day 0 and Day 28
Percentage of participants achieving pre-defined Seroprotection Before and following vaccination

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy adults aged over 65 years old
Informed consent form has been signed and dated

Exclusion Criteria:

Known systemic hypersensitive to eggs, chicken proteins, or any of the vaccine components
Personal history of Guillain-Barre syndrome(GBS)
Subjects with severe chronic disease who are considered by investigator to be ineligible for the study
Subjects who received a vaccination within 28 days before enrollment or who are scheduled for another vaccination during the study
Immunocompromised subjects with immunodeficiency disease or subjects receiving immunosuppressive or immunomodulating therapy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Woo Joo KIm, M.D, Ph.D	Korea University Guro Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Korea University Guro Hospital		Seoul			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D007251	Influenza, Human

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections

Browse Leaves

Not provided

Browse Branches

Not provided