Study of Egg-derived Influenza Vaccine and Cell Culture-derived Influenza Vaccine in Adult and Elderly Subjects

Study Overview
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Brief Summary
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The purpose of this study is to describe the immunogenicity and safety of the cell culture-derived influenza vaccine compared with the egg-derived influenza vaccine among subjects. To describe the immunogenicity, antibody levels are evaluated by hemagglutination inhibition(HI) assay from sera obtained pre-vaccination and 21 days post-vaccination. To describe the safety, the time of onset and duration of local and systemic solicited adverse events are assessed and reported. Unsolicited adverse events and serious adverse events are collected and categorized throughout the study period.

Detailed Description
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This is a multi-center, randomized, double-blind study in healthy adult and elderly subjects. Subjects receive a single dose of one of the influenza vaccine formulations and provide blood samples for immunogenicity assessment.

Official Title
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A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess the Immunogenicity and Safety of NBP607 (Trivalent Inactivated Cell Culture-derived Influenza Vaccine) in Healthy Adults and Elderly Subjects

Conditions
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Influenza, Human

Intervention / Treatment
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* Biological: NBP607
* Biological: Agrippal S1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults aged 19 years or older. The subjects who give written consent to participate in the study voluntarily and are able to comply with all study requirements. If female and capable of bearing children,subject has a negative urine pregnancy test result on screening and agrees to employ adequate birth control measures through the study period. Exclusion Criteria: Subjects who are hypersensitive to any component of vaccine, i.e., eggs, chicken or chicken products. Subjects with immune deficiency disorder. History of Guillain-Barre syndrome. Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination. Subjects who experienced fever within 24 hours before vaccination or with the febrile disease(exceeding 38.0℃) on screening day or with any acute respiratory infection. Subjects who had received immunosuppressant or immune-modifying drug within 3 months before screening. Subjects who had received blood products or immunoglobulin within 3 months before screening. Subjects who had received influenza vaccination within 6 months prior to the screening. Subjects who had received other vaccination within a month before screening, or those who had another vaccination scheduled within a month after study vaccination. Subjects who had participated in other clinical trial within 4 weeks prior to study vaccination. Subjects who had done blood donation within a week prior to study vaccination or planned blood donation within 7 months after study vaccination. Subjects with clinically significant chronic disease or malignant cancer. Pregnant women, breast-feeding women. Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NBP607<br>cell culture-derived trivalent inactivated subunit influenza vaccine | Biological: NBP607<br>* 0.5 mL, intramuscular, a single dose<br>|
| Active Comparator: Agrippal S1<br>egg-derived trivalent inactivated subunit influenza vaccine | Biological: Agrippal S1<br>* 0.5 mL, intramuscular, a single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigen | Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Post-Vaccination. Percentage of Participants Achieving Seroconversion at Day 21 Post-Vaccination With Influenza Vaccine. Pre- and Post- Vaccination Geometric Mean Ratio (GMR) | Day 0 and Day 21 post-vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity in subjects with a pre-vaccination HI antibody titer <1:80 |  | Day 0 and Day 21 post-vaccination | 
| Immunogenicity compared to control group |  | Day 21 post vaccination, 6 months post vaccination | 
| Long-term Immunogenicity |  | 6 months post-vaccination | 
| Percentage of participants with Solicited Local Adverse Event (AE) |  | During 7 days post-vaccination | 
| Percentage of participants with Solicited Systemic Adverse Event (AE) |  | During 7 days post-vaccination | 
| Percentage of participants with Unsolicited Adverse Event (AE) |  | During 21 days post-vaccination | 
| Percentage of participants with Severe Adverse Event (SAE) |  | During 6 months post-vaccination | 
| Vital Sign | Body Temperature, Blood Pressure(SBP/DBP), Pulse | Day 0 and Day 21 post vaccination | 
| Physical Examination | inspection, palpation (feel), percussion (tap to determine resonance characteristics), and auscultation (listen) | Day 0 and Day 21 post vaccination | 
| Clinical Laboratory Tests | Blood test(CBC, Coagulation, Chemistry), Urinalysis | Day 0 and Day 21 post vaccination |