A Study to Evaluate the Efficacy and Safety of GC3110A in Healthy Subjects Aged 65 Years and Older

Phase 3

Completed

• Conditions: Influenza, Human
• Interventions: Biological: GC3110A vaccine

• Registration Number: NCT02917304
• Lead Sponsor: Green Cross Corporation

Brief Summary

The purpose of this study is to evaluate immunological efficacy and safety of GC3110A among healthy adults over 65 years of age.

Detailed Description

Adults over 65 years of age will be once administered GC3110A(Quadrivalent influenza vaccine).

Study Timeline

• Study First Submitted: 2016-09-26
• Study First Submitted QC: 2016-09-26
• Study First Posted: 2016-09-28
• Study Start: 2016-10-10
• Primary Completion: 2016-12-02
• Status Verified: 2017-05
• Study Completion: 2017-05-08
• Last Update Submitted: 2017-05-24
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 274

Inclusion Criteria

• Healthy adults aged 65 years and older
• Informed consent form has been signed and dated
• Able to comply with the requirements of the study

Exclusion Criteria

• Known systemic hypersensitivity 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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GC3110A vaccine group	GC3110A vaccine	Participants administered a single dose of GC3110A(Quadrivalent Influenza Vaccine).

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Pre-defined Seroconversion Before and following vaccination	Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)	Percentage of Participants Achieving Pre-defined Seroconversion Before and following vaccination
Percentage of Participants Achieving Pre-defined Seroprotection Before and following vaccination	Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)	Percentage of Participants Achieving Pre-defined Seroprotection Before and following vaccination

Secondary Outcome Measures

Name	Time	Method
Geometric Mean Titer and Geometric Mean Titer Ratios of Antibodies to the GC3110A Before and Following Vaccination	Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)	Geometric Mean Titer and Geometric Mean Titer Ratios of Antibodies to the GC3110A Before and Following Vaccination

Trial Locations

Locations (10)

Soon Chun Hyang University Bucheon Hospital; 🇰🇷 Gyeonggi-do, Korea, Republic of

The Catholic Univ. of Korea Daejeon St.Mary's Hospital; 🇰🇷 Daejeon, Korea, Republic of

The Catholic Univ.of Korea Uijeongbu St.Mary's Hospital; 🇰🇷 Gyeonggi-do, Korea, Republic of

The Catholic Univ.of Korea Bucheon St.Mary's Hospital; 🇰🇷 Gyeonggi-do, Korea, Republic of

Soon Chun Hyang University Seoul Hospital; 🇰🇷 Seoul, Korea, Republic of

KyungHee University Medical Center; 🇰🇷 Seoul, Korea, Republic of

The Catholic Univ. of Korea Incheon St.Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

EWHA woman's university mokdong hospital; 🇰🇷 Seoul, Korea, Republic of

The Catholic Univ.of Korea Yeouido St.Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

The Catholic Univ.of Korea Seoul St.Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of