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

NCT02915809 | Unknown Phase 3

• 1 other identifier: GC3110B_P3
• Study Type: interventional
• Target: 414
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Influenza, Human

Keywords

Influenza Vaccines

Outcome Measures

Primary Outcomes (1)

• Geometric Mean Titer Ratios of Antibodies to the GC3110B or GCFLU Quadrivalent Inj.

  Geometric mean titers of antibodies will be assessed using the hemagglutination inhibition (HI) assay.

  Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)

Secondary Outcomes (4)

• Percentage of Participants Achieving Pre-Defined Seroconversion Before and Following Vaccination

  Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)

• Percentage of Participants Achieving Pre-Defined Seroprotection Before and Following Vaccination

  Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)

• Number and Percentage of Participants Reporting Solicited Adverse Events Following Vaccination

  Day 0 to Day 6

• Number and Percentage of Participants Reporting Unsolicited Adverse Events Following Vaccination

  Day 0 to Day 21

Study Arms (2)

GC3110B Vaccine Group

EXPERIMENTAL

Participants randomized to receive a single dose of GC3110B vaccine (Biological: GC3110B vaccine).

Biological: GC3110B vaccine

GCFLU Quadrivalent Inj.

ACTIVE COMPARATOR

Participants randomized to receive a single dose of GCFLU Quadrivalent Inj. vaccine (Biological: GCFLU Quadrivalent Inj. vaccine).

Biological: GCFLU Quadrivalent Inj. vaccine

Interventions

GC3110B vaccine BIOLOGICAL

0.5mL, Intramuscular

Also known as: GC3110B

GC3110B Vaccine Group

GCFLU Quadrivalent Inj. vaccine BIOLOGICAL

0.5mL, Intramuscular

Also known as: GCFLU Quadrivalent Inj.

GCFLU Quadrivalent Inj.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults aged 18 to 60 years
• Informed consent form has been signed and dated
• Able to comply with the requirements of the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Green Cross Corporation: lead

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2016
• First Posted: September 27, 2016
• Study Start: October 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: May 1, 2017
• Last Updated: September 29, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share