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Completed

NCT Number: NCT02917304

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

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

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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 3

Primary location

The Catholic Univ. of Korea Daejeon St.Mary's Hospital, Daejeon, South Korea

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

GC3110A vaccine

Biological

0.5mL, Intramuscular

Other names: GC3110A

Primary outcomes

  1. Percentage of Participants Achieving Pre-defined Seroconversion Before and following vaccination

    Time frame: Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)

    Percentage of Participants Achieving Pre-defined Seroconversion Before and following vaccination

  2. Percentage of Participants Achieving Pre-defined Seroprotection Before and following vaccination

    Time frame: Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)

    Percentage of Participants Achieving Pre-defined Seroprotection Before and following vaccination

Secondary outcomes

  1. Geometric Mean Titer and Geometric Mean Titer Ratios of Antibodies to the GC3110A Before and Following Vaccination

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Green Cross Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Sep 28, 2016
Registry last updated
May 30, 2017

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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