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OpenTrials
Completed

NCT Number: NCT03657719

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

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

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Key information

Conditions

Influenza, Human Infections Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Korea University Guro Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GC3114

Biological

High-dose Quadrivalent influenza vaccine

GCFLU Quadrivalent

Biological

Quadrivalent influenza vaccine

Primary outcomes

  1. Adverse Event

    Time frame: for 7 days from Day0/during study period

    Solicited/Unsolicited Adverse Event

Secondary outcomes

  1. Percentage of participants achieving pre-defined Seroconversion Before and following vaccination

    Time frame: Day 0 and Day 28

    Seroconversion rate (SCR)

  2. Percentage of participants achieving pre-defined Seroprotection Before and following vaccination

    Time frame: Day 0 and Day 28

    Seroprotection rate (SPR)

  3. Geometric Mean Titer of Antibodies to the Investigational Product Before and Following vaccination

    Time frame: Day 0 and Day 28

    Geometric Mean Titer(GMT)

  4. Geometric Mean Ratio of Antibodies to the Investigational Product Before and Following vaccination

    Time frame: Day 0 and Day 28

    Geometric Mean Ratio(GMR)

Sponsors and collaborators

Lead sponsor

Green Cross Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Sep 5, 2018
Registry last updated
Jan 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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