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NCT03657719 Clinical Trial

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

Influenza, Human Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03657719
Other study ID # GC3114_P2
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date October 1, 2018
Est. completion date December 13, 2018

Study information
Verified date January 2019
Source Green Cross Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 105
Est. completion date December 13, 2018
Est. primary completion date December 13, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• GC3114
High-dose Quadrivalent influenza vaccine
• GCFLU Quadrivalent
Quadrivalent influenza vaccine

Locations
Country Name City State
Korea, Republic of Korea University Guro Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Green Cross Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse Event Solicited/Unsolicited Adverse Event for 7 days from Day0/during study period
Secondary Percentage of participants achieving pre-defined Seroconversion Before and following vaccination Seroconversion rate (SCR) Day 0 and Day 28
Secondary Percentage of participants achieving pre-defined Seroprotection Before and following vaccination Seroprotection rate (SPR) Day 0 and Day 28
Secondary Geometric Mean Titer of Antibodies to the Investigational Product Before and Following vaccination Geometric Mean Titer(GMT) Day 0 and Day 28
Secondary Geometric Mean Ratio of Antibodies to the Investigational Product Before and Following vaccination Geometric Mean Ratio(GMR) Day 0 and Day 28
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