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A Study to Evaluate Efficacy and Safety of GC3110B in Healthy Adults

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ClinicalTrials.gov Identifier: NCT02915809
Recruitment Status : Unknown
Verified September 2016 by Green Cross Corporation.
Recruitment status was:  Not yet recruiting
First Posted : September 27, 2016
Last Update Posted : September 29, 2016
Sponsor:
Information provided by (Responsible Party):
Green Cross Corporation

Brief Summary:
The purpose of this study is to evaluate immunological efficacy and safety of GC3110B versus GCFLU Quadrivalent Inj. among healthy adults in 18 to 60 years of age.

Condition or disease Intervention/treatment Phase
Influenza, Human Biological: GC3110B vaccine Biological: GCFLU Quadrivalent Inj. vaccine Phase 3

Detailed Description:
Adults 18 to 60 years of age will be randomly assigned in a 1:1 ratio to receive either GC3110B or GCFLU Quadrivalent Inj.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 414 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized, Double-Blind, Multicenter Study to Compare the Immunological Efficacy and Safety of GC3110B With GCFLU Quadrivalent Inj. Administered Intramuscularly in Healthy Adults
Study Start Date : October 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: GC3110B Vaccine Group
Participants randomized to receive a single dose of GC3110B vaccine (Biological: GC3110B vaccine).
Biological: GC3110B vaccine
0.5mL, Intramuscular
Other Name: GC3110B

Active Comparator: GCFLU Quadrivalent Inj.
Participants randomized to receive a single dose of GCFLU Quadrivalent Inj. vaccine (Biological: GCFLU Quadrivalent Inj. vaccine).
Biological: GCFLU Quadrivalent Inj. vaccine
0.5mL, Intramuscular
Other Name: GCFLU Quadrivalent Inj.




Primary Outcome Measures :
  1. Geometric Mean Titer Ratios of Antibodies to the GC3110B or GCFLU Quadrivalent Inj. [ Time Frame: Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination) ]
    Geometric mean titers of antibodies will be assessed using the hemagglutination inhibition (HI) assay.


Secondary Outcome Measures :
  1. Percentage of Participants Achieving Pre-Defined Seroconversion Before and Following Vaccination [ Time Frame: Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination) ]
    Seroconversion is defined as either a pre-vaccination titer <1:10 and a post-vaccination titer ≥ 1: 40 or a pre-vaccination titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination titer 21 days after vaccination.

  2. Percentage of Participants Achieving Pre-Defined Seroprotection Before and Following Vaccination [ Time Frame: Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination) ]
    Antibodies will be assessed using the hemagglutination inhibition (HI) assay. Seroprotection is defined as a titer ≥1:40 at pre-vaccination and 21 days after vaccination.

  3. Number and Percentage of Participants Reporting Solicited Adverse Events Following Vaccination [ Time Frame: Day 0 to Day 6 ]
  4. Number and Percentage of Participants Reporting Unsolicited Adverse Events Following Vaccination [ Time Frame: Day 0 to Day 21 ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adults aged 18 to 60 years
  • 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-Barré syndrome
  • 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

Responsible Party: Green Cross Corporation
ClinicalTrials.gov Identifier: NCT02915809     History of Changes
Other Study ID Numbers: GC3110B_P3
First Posted: September 27, 2016    Key Record Dates
Last Update Posted: September 29, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Green Cross Corporation:
Influenza Vaccines

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs