Clinical Trials Logo
  1. Home
  2. Influenza, Human
  3. NCT03357263
  4. Details
NCT03357263 Clinical Trial

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

Influenza, Human Clinical Trial

Official title:
Randomized, Single-Blind, Active Comparator-controlled Study to Evaluate the Safety and Immunological Efficacy of GC3114 in Healthy Adults.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03357263
Other study ID # GC3114_P1
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date November 20, 2017
Est. completion date December 22, 2017

Study information
Verified date November 2018
Source Green Cross Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

Healthy adults 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 40
Est. completion date December 22, 2017
Est. primary completion date December 22, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 64 Years
Eligibility Inclusion Criteria:

- Healthy adults aged 19-64 years old

- Informed consent form has been signed and dated

- Able to comply with the requirements of the study

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

- Pregnant or lactating women

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 21
Secondary Percentage of participants achieving pre-defined Seroprotection Before and following vaccination Seroprotection rate (SPR) Day 0 and Day 21
Secondary Geometric Mean Titer and Geometric Mean Titer Ratios of Antibodies to the Investigational Product Before and Following vaccination Geometric Mean Titer(GMT), Geometric Mean Titer(GMT) Day 0 and Day 21
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 NCT02984280 - Specific Respiratory Infections as Triggers of Acute Medical Events N/A
Withdrawn NCT02883972 - Childhood Influenza Immunisation Invitation Trial in Schools N/A
Completed NCT02867358 - A Clinical Trial of KT07 Capsule in the U.S.A Phase 2
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 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 NCT02243774 - Mail Outreach To Increase Vaccination Acceptance Through Engagement N/A
Completed NCT02344134 - Study of Egg-derived Influenza Vaccine and Cell Culture-derived Influenza Vaccine in Adult and Elderly Subjects Phase 3