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

September 27, 2016 updated by: Green Cross Corporation

A Randomized, Double-Blind, Multicenter Study to Compare the Immunological Efficacy and Safety of GC3110B With GCFLU Quadrivalent Inj. Administered Intramuscularly in Healthy Adults

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

414

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • GCFLU Quadrivalent Inj.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)
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.
Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)
Number and Percentage of Participants Reporting Solicited Adverse Events Following Vaccination
Time Frame: Day 0 to Day 6
Day 0 to Day 6
Number and Percentage of Participants Reporting Unsolicited Adverse Events Following Vaccination
Time Frame: Day 0 to Day 21
Day 0 to Day 21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Green Cross Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

May 1, 2017

Study Registration Dates

First Submitted

September 25, 2016

First Submitted That Met QC Criteria

September 26, 2016

First Posted (Estimate)

September 27, 2016

Study Record Updates

Last Update Posted (Estimate)

September 29, 2016

Last Update Submitted That Met QC Criteria

September 27, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GC3110B_P3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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