Clinical Trials Logo
  1. Home
  2. Influenza, Human
  3. NCT02917304
  4. Details
NCT02917304 Clinical Trial

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

Influenza, Human Clinical Trial

Official title:
A Multicenter, Open-label, Single Arm Study to Evaluate the Immunological Efficacy and Safety of GC3110A. Administered Intramuscularly in Healthy Subjects Aged 65 Years and Older

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02917304
Other study ID # GC3110A_ED_P3
Secondary ID
Status Completed
Phase Phase 3
First received September 26, 2016
Last updated May 24, 2017
Start date October 10, 2016
Est. completion date May 8, 2017

Study information
Verified date May 2017
Source Green Cross Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 274
Est. completion date May 8, 2017
Est. primary completion date December 2, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Biological:
• GC3110A vaccine
0.5mL, Intramuscular

Locations
Country Name City State
Korea, Republic of The Catholic Univ. of Korea Daejeon St.Mary's Hospital Daejeon
Korea, Republic of Soon Chun Hyang University Bucheon Hospital Gyeonggi-do
Korea, Republic of The Catholic Univ.of Korea Bucheon St.Mary's Hospital Gyeonggi-do
Korea, Republic of The Catholic Univ.of Korea Uijeongbu St.Mary's Hospital Gyeonggi-do
Korea, Republic of EWHA woman's university mokdong hospital Seoul
Korea, Republic of KyungHee University Medical Center Seoul
Korea, Republic of Soon Chun Hyang University Seoul Hospital Seoul
Korea, Republic of The Catholic Univ. of Korea Incheon St.Mary's Hospital Seoul
Korea, Republic of The Catholic Univ.of Korea Seoul St.Mary's Hospital Seoul
Korea, Republic of The Catholic Univ.of Korea Yeouido St.Mary's 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 Percentage of Participants Achieving Pre-defined Seroconversion Before and following vaccination Percentage of Participants Achieving Pre-defined Seroconversion Before and following vaccination Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)
Primary Percentage of Participants Achieving Pre-defined Seroprotection Before and following vaccination Percentage of Participants Achieving Pre-defined Seroprotection Before and following vaccination Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)
Secondary Geometric Mean Titer and Geometric Mean Titer Ratios of Antibodies to the GC3110A Before and Following Vaccination 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)
See also
  Status Clinical Trial Phase
Completed NCT03275389 - A Study to Evaluate the Reactogenicity, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Investigational Supra-seasonal Universal Influenza Vaccines - Inactivated (SUIVs) (GSK3816302A) in Healthy Adults Aged 18 to 39 Years Phase 1
Completed NCT03442582 - Afluria Pregnancy Registry
Completed NCT05981846 - A Phase II Trial to Evaluate the Safety and Immunogenicity of BIMERVAX® When Coadministered With Seasonal Influenza Vaccine (SIIV) in Adults Older Than 65 Years of Age Fully Vaccinated Against COVID-19 Phase 2
Completed NCT05044195 - A Clinical Study to Evaluate the Immunogenicity and Safety of an Adjuvanted Quadrivalent Influenza Vaccine Compared With a Licensed Quadrivalent Vaccine in Adults 50 to 64 Years of Age Phase 3
Completed NCT02914275 - A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 6 Months Through 59 Months of Age. Phase 3
Completed NCT04590066 - Testing Multiple Behavioral Science Strategies to Increase Flu-Shot Rates at a Large Retail Pharmacy N/A
Recruiting NCT03778203 - Development of Childhood Anti-influenza Immunity Phase 4
Completed NCT04527614 - Influence of Prior Infection With COVID-19 on Occurrence of Influenza-like Illness or Acute Respiratory Infection N/A
Terminated NCT03658629 - Phase 2 Dose and Formulation Confirmation of Quad-NIV in Older Adults Phase 2
Completed NCT05269290 - Efficacy and Safety of Ingavirin®, Syrup, 30 mg/5 ml, in Children With Influenza and Other Acute Respiratory Viral Infections Phase 3
Completed NCT06385821 - A Study to Prove Non-inferior Immunogenicity of Grippol Quadrivalent Compared to Grippol Plus Phase 3
Completed NCT02867358 - A Clinical Trial of KT07 Capsule in the U.S.A Phase 2
Completed NCT02984280 - Specific Respiratory Infections as Triggers of Acute Medical Events N/A
Withdrawn NCT02883972 - Childhood Influenza Immunisation Invitation Trial in Schools N/A
Completed NCT02998996 - Study to Assess the Safety, Tolerability and Immune Response Following Vaccination With Immunose™ FLU Phase 1/Phase 2
Completed NCT02545543 - A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 5 Through 17 Years of Age Phase 3
Completed NCT02243774 - Mail Outreach To Increase Vaccination Acceptance Through Engagement N/A
Completed NCT02212106 - A Study to Evaluate the Safety and Tolerability of Trivalent Influenza Virus Vaccine in Children Aged 5 Years to < 9 Years Phase 4
Completed NCT02621164 - Immunogenicity and Safety of Quadrivalent Influenza Vaccine in Children and Adolescents Phase 3
Completed NCT02344134 - Study of Egg-derived Influenza Vaccine and Cell Culture-derived Influenza Vaccine in Adult and Elderly Subjects Phase 3