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.

Prevention of Influenza Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02067117
• Other study ID #: GCFLU_P4
• Status: Completed
• Phase: Phase 4
• First received: January 19, 2014
• Last updated: February 18, 2014
• Start date: October 2010
• Est. completion date: November 2010

Study information

• Verified date: February 2014
• Source: Green Cross Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Korea Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1139
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prevention of Influenza

Intervention

Drug:
• GC FLU® Injection, GC FLU® Pre-filled Syringe Injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Green Cross Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GMT (Geometric Mean Titre) of HI antibody titrebefore vaccination (Day 0) and after vaccination		Day 21	No
Secondary	The percentage of subjects achieving seroconversion for HI antibody (Seroconversion rate)		Day21	No
Secondary	GMT (Geometric Mean Titre) of HI antibody titre before vaccination (Day 0) and after vaccination		Day 21	No
Secondary	Solicited local adverse events (topical symptoms) and solicited general adverse events (systemic symptoms) occurring from the date of vaccination until 6 days after vaccination		Day 6	Yes
Secondary	The percentage of subjects achieving HI antibody titre = 1:40 following the receipt of vaccination (Seroprotection rate).		Day21	No
Secondary	The percentage of subjects achieving seroconversion for HI antibody (Seroconversion rate)		Day 21	No
Secondary	The percentage of subjects achieving HI antibody titre = 1:40 following the receipt of vaccination(Seroprotection rate).		Day 21	No
Secondary	Unsolicited adverse events occurring from the date of vaccination until 21 days after vaccination		Day 21	Yes