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.

NCT02067117 | Completed Phase 4

• 1 other identifier: GCFLU_P4
• Study Type: interventional
• Target: 1,139
• Locations: 0 countries
• Sites: N/A

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

Conditions

Prevention of Influenza

Keywords

influenza

Outcome Measures

Primary Outcomes (1)

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

  Day 21

Secondary Outcomes (7)

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

  Day21

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

  Day 21

• 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

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

  Day21

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

  Day 21

Study Arms (1)

influenza split vaccine

EXPERIMENTAL

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

Interventions

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

influenza split vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[adults\]
• 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.

You may not qualify if:

• 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.

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 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2014
• First Posted: February 20, 2014
• Study Start: October 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: February 20, 2014

Record last verified: 2014-02