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

Influenza, Human Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02915809
• Other study ID #: GC3110B_P3
• Status: Not yet recruiting
• Phase: Phase 3
• First received: September 25, 2016
• Last updated: September 27, 2016
• Start date: October 2016
• Est. completion date: May 2017

Study information

• Verified date: September 2016
• Source: Green Cross Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines : Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 414
• Est. completion date: May 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza, Human

Intervention

Biological:
• GC3110B vaccine
0.5mL, Intramuscular
• GCFLU Quadrivalent Inj. vaccine
0.5mL, Intramuscular

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Green Cross Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Percentage of Participants Achieving Pre-Defined Seroconversion Before and Following 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)	No
Secondary	Percentage of Participants Achieving Pre-Defined Seroprotection Before and Following 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)	No
Secondary	Number and Percentage of Participants Reporting Solicited Adverse Events Following Vaccination		Day 0 to Day 6	Yes
Secondary	Number and Percentage of Participants Reporting Unsolicited Adverse Events Following Vaccination		Day 0 to Day 21	Yes