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Demonstrate the Lot-to-lot Consistency of 3 Consecutive Batches and to Evaluate the Efficacy and Safety of GC FLU®Pre-filled Syringe Injection and 'GC FLU®Injection' Administration.

Primary Purpose

Prevention of Influenza

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

GC FLU® Injection, GC FLU® Pre-filled Syringe Injection

About this trial

This is an interventional prevention trial for Prevention of Influenza focused on measuring influenza

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy adults≥ 18 and < 65years of age who can be followed up for 21 days.

Depending on the part of the study that a subject was going to participate, age criteria were further divided as follows:

Lot-to-lot consistency study [PART A]: ≥ 18 to < 65 years of age Annual clinical trial [PART B]: ≥ 18 to < 65 years of age [adults]

65 years of age [elderly population]
- Subjects who gave voluntary written consent to participate in the study, and are able to comply with the study requirements.

Exclusion Criteria:

Subjects with a known hypersensitivity of allergic reaction to eggs or egg products, to chicken or chichenproducts, to any component of the study vaccine, neomycin or gentanicin.
Subjects with immune system disorders, including immune deficiency disease.
Subjects with a history of Guillain-Barre syndrome.
Subjects with severe chronic disease (e.g., cardiovascular disease except for controlled hypertension, respiratory disease, metabolic disease, renal dysfunction or hemoglobinopathy, etc.) who in the investigator's opinion may have difficulty in participating in the study.
Subjects with haemophilia or receiving a treatment with an anticoagulant, who are at increased risk of serious bleeding during intramuscular injection.
Subjects who had acute fever with the body temperature exceeding 38.0 °C within 72 hours before vaccination with the study drug.
Subjects who had received other vaccinations within 7 days before vaccination with the study drug, or those who had another vaccination scheduled during the study.
Subjects who had received immunosuppressant or immune modifying drug within 3 months before vaccination with the study drug.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

influenza split vaccine

Arm Description

Outcomes

Primary Outcome Measures

GMT (Geometric Mean Titre) of HI antibody titrebefore vaccination (Day 0) and after vaccination

Secondary Outcome Measures

The percentage of subjects achieving seroconversion for HI antibody (Seroconversion rate)

GMT (Geometric Mean Titre) of HI antibody titre before vaccination (Day 0) and after vaccination

Solicited local adverse events (topical symptoms) and solicited general adverse events (systemic symptoms) occurring from the date of vaccination until 6 days after vaccination

The percentage of subjects achieving HI antibody titre ≥ 1:40 following the receipt of vaccination (Seroprotection rate).

The percentage of subjects achieving seroconversion for HI antibody (Seroconversion rate)

The percentage of subjects achieving HI antibody titre ≥ 1:40 following the receipt of vaccination(Seroprotection rate).

Unsolicited adverse events occurring from the date of vaccination until 21 days after vaccination

Full Information

NCT ID

NCT02067117

First Posted

January 19, 2014

Last Updated

February 18, 2014

Sponsor

Green Cross Corporation

1. Study Identification

Unique Protocol Identification Number

NCT02067117

Brief Title

Demonstrate the Lot-to-lot Consistency of 3 Consecutive Batches and to Evaluate the Efficacy and Safety of GC FLU®Pre-filled Syringe Injection and 'GC FLU®Injection' Administration.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Completed

Study Start Date

October 2010 (undefined)

Primary Completion Date

November 2010 (Actual)

Study Completion Date

November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Green Cross Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study is aimed to confirm the lot-to-lot consistency of 3 consecutive batches of 'GC FLU® Pre-filled Syringe Injection' and 'GC FLU® Injection' in the lot-to-lot

Detailed Description

This is a Post-Marketing, Multicentre, Open, Randomized Phase 4 Clinical Study. Subjects who gave voluntary written informed consent to participate in the study were screened for eligibility in the study, and those who met the eligibility criteria were randomized in the investigational group. An investigator assessed the effectiveness (immunogenicity) and safety of the study vaccine in each subject during his/her participation in the study. Subjects were randomized (Visit 1) into the investigational group according to a randomization table previously generated, and were vaccinated with influenza split vaccine, 'GC FLU®Pre-filled Syringe Injection' and 'GC FLU®Injection'. 12 Assessments for HI titre to each strain of influenza were performed at Visit 1 (pre-vaccination), and at Visit 3 (21 days after vaccination) for the efficacy (immunogenicity) evaluation [Picture 1].For the safety assessment, subject diaries were handed out to subjects, who were instructed to record any adverse event emerging ager the receipt of study vaccine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prevention of Influenza

Keywords

influenza

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1139 (Actual)

8. Arms, Groups, and Interventions

Arm Title

influenza split vaccine

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

GC FLU® Injection, GC FLU® Pre-filled Syringe Injection

Primary Outcome Measure Information:

Title

GMT (Geometric Mean Titre) of HI antibody titrebefore vaccination (Day 0) and after vaccination

Time Frame

Day 21

Secondary Outcome Measure Information:

Title

The percentage of subjects achieving seroconversion for HI antibody (Seroconversion rate)

Time Frame

Day21

Title

GMT (Geometric Mean Titre) of HI antibody titre before vaccination (Day 0) and after vaccination

Time Frame

Day 21

Title

Solicited local adverse events (topical symptoms) and solicited general adverse events (systemic symptoms) occurring from the date of vaccination until 6 days after vaccination

Time Frame

Day 6

Title

The percentage of subjects achieving HI antibody titre ≥ 1:40 following the receipt of vaccination (Seroprotection rate).

Time Frame

Day21

Title

The percentage of subjects achieving seroconversion for HI antibody (Seroconversion rate)

Time Frame

Day 21

Title

The percentage of subjects achieving HI antibody titre ≥ 1:40 following the receipt of vaccination(Seroprotection rate).

Time Frame

Day 21

Title

Unsolicited adverse events occurring from the date of vaccination until 21 days after vaccination

Time Frame

Day 21

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy adults≥ 18 and < 65years of age who can be followed up for 21 days. Depending on the part of the study that a subject was going to participate, age criteria were further divided as follows: Lot-to-lot consistency study [PART A]: ≥ 18 to < 65 years of age Annual clinical trial [PART B]: ≥ 18 to < 65 years of age [adults] 65 years of age [elderly population] Subjects who gave voluntary written consent to participate in the study, and are able to comply with the study requirements. Exclusion Criteria: Subjects with a known hypersensitivity of allergic reaction to eggs or egg products, to chicken or chichenproducts, to any component of the study vaccine, neomycin or gentanicin. Subjects with immune system disorders, including immune deficiency disease. Subjects with a history of Guillain-Barre syndrome. Subjects with severe chronic disease (e.g., cardiovascular disease except for controlled hypertension, respiratory disease, metabolic disease, renal dysfunction or hemoglobinopathy, etc.) who in the investigator's opinion may have difficulty in participating in the study. Subjects with haemophilia or receiving a treatment with an anticoagulant, who are at increased risk of serious bleeding during intramuscular injection. Subjects who had acute fever with the body temperature exceeding 38.0 °C within 72 hours before vaccination with the study drug. Subjects who had received other vaccinations within 7 days before vaccination with the study drug, or those who had another vaccination scheduled during the study. Subjects who had received immunosuppressant or immune modifying drug within 3 months before vaccination with the study drug.

12. IPD Sharing Statement

Learn more about this trial

Demonstrate the Lot-to-lot Consistency of 3 Consecutive Batches and to Evaluate the Efficacy and Safety of GC FLU®Pre-filled Syringe Injection and 'GC FLU®Injection' Administration.

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