Safety, Tolerability and Immunogenicity of an Trivalent Inactivated Cell-Culture Influenza Vaccine in Healthy Adults

Study Overview
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Brief Summary
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A randomized, double-blinded, controlled, Phase I clinical trial to assess the safety, tolerability and immunogenicity of 'NBP607(trivalent inactivated cell-culture influenza vaccine)' compared to egg-based influenza vaccine in healthy adult volunteers

Detailed Description
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Assessment of Safety Assessment of Immunogenicity Estimated Enrollment: 100

Official Title
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Randomized, Double-blinded, Controlled, Phase I Trial to Assess Safety, Tolerability and Immunogenicity of 'NBP607(Trivalent Inactivated Cell-Culture Influenza Vaccine)' Compared to Egg-based Influenza Vaccine in Healthy Adult

Conditions
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Prevention of Influenza

Intervention / Treatment
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* Biological: NBP607
* Biological: Agrippal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 20 to <60 years of age able and willing to give written informed consent prior to study entry if female, at least 2 years after post- menopausal and negative result of urine-human chorionic gonadotropin (HCG) test at screening Exclusion Criteria: hypersensitivity to any component of the study medication or chemically related substances, such as allergy to eggs or egg products Immunodeficiency disease history of hypersensitivity when vaccination, such as Guillain-Barre syndrome thrombocytopenia or Coagulation disorders experienced fever (>37.5°C) within the past 24 hours or any acute respiratory infection receipt of Immunosuppressants or Immunomodulators within the past 3 months receipt of blood products or immunoglobulin within the past 3 months received influenza vaccine within the past 6 months received another vaccine within the past 1 month or plans vaccination within 1 months following the study vaccination participation on another clinical trial within 1 month prior to the study vaccination history of blood donation within 1 week prior to the study vaccination for plan of blood donation within 7 days following the study vaccination any chronic diseases that interfere with the clinical trial or Malignant tumors pregnant or breastfeeding any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives or might interfere with the safety of the study subject.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 59 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: Group 1<br>NBP607 0.5ml | Biological: NBP607<br>* 1 dose, 0.5ml, Intramuscular (IM) injection<br>|
| Active Comparator: Group 2<br>Agrippal 0.5ml | Biological: Agrippal<br>* 1 dose, 0.5ml, Intramuscular (IM) injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of solicited local adverse events (AEs) | All AEs were classified and analyzed according to its severity and causality. The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated. | Within 21 days after vaccination | 
| Incidence rate of solicited systemic AEs | All AEs were classified and analyzed according to its severity and causality. The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated. | Within 21 days after vaccination | 
| Incidence rate of unsolicited AEs | All AEs were classified and analyzed according to its severity and causality. The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated. | Within 21 days after vaccination | 
| Pulse rate at each visit | Comparisons within each group between pre-/post- vaccination were summarized and presented. | 0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination | 
| Blood pressure(systolic/diastolic) at each visit | Comparisons within each group between pre-/post- vaccination were summarized and presented. | 0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination | 
| Body temperature at each visit | Comparisons within each group between pre-/post- vaccination were summarized and presented. | 0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination | 
| Rate of normal/abnormal results in Electrocardiogram (ECG) (ventricular rate, PR interval, QRS, QT, and QTc) collected during screening visit and close-out visit | Comparisons within each group between pre-/post- vaccination were summarized and presented. | Screening visit(0-14 days prior to vaccination)/close-out visit(21-28 days after vaccination) | 
| Rate of normal/abnormal results in physical examination at each visit | Comparisons within each group between pre-/post- vaccination were summarized and presented. | 0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination | 
| Rate of normal/abnormal results in clinical laboratory tests(Platelet, Cl, etc.) during screening visit and close-out visit | Comparisons within each group between pre-/post- vaccination were summarized and presented. | Screening visit(0-14 days prior to vaccination)/close-out visit(21-28 days after vaccination) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroconversion rate measured by pre-/post-vaccination Haemagglutination Inhibition (HI) titer[Immunogenicity] | The proportion of subjects achieving one of the following conditions; i)If the pre-vaccination HI titer were <1:10, subjects achieving an HI titer ≥1:40 after vaccination ii)If the pre-vaccination HI titers were ≥1:10, subjects with a minimum 4-fold rise in HI titer | 21-28 days after vaccination | 
| Geometric Mean Ratio (GMR) measured by pre-/post-vaccination HI titer[Immunogenicity] | The mean increase in geometric mean HI titer | 21-28 days after vaccination | 
| Seroprotection rate measured by post-vaccination HI titer[Immunogenicity] | The proportion of subjects with post-vaccination HI titers of ≥1:40 | 21-28 days after vaccination |