Safety, Tolerability and Immunogenicity of NBP607QIV in Healthy Adult Volunteers

Study Overview
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Brief Summary
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This study assesses safety, tolerability and immunogenicity of NBP607QIV to Agrippal which are indicated for active immunization for the prevention of influenza disease.

Detailed Description
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Subjects are randomly assigned in a 1:1 ratio to NBP607QIV versus Agrippal S1. To assess the safety, solicited adverse events for 7 days post-vaccination and unsolicited adverse events for 28 days post-vaccination are assessed and reported. To assess the immunogenicity, antibody levels are evaluated by hemagglutination inhibition(HI) assay from sera obtained at pre-vaccination and 21 days post-vaccination.

Official Title
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A Randomized, Double-blinded, Controlled, Phase I/II Clinical Trial to Assess the Safety, Tolerability and Immunogenicity of NBP607QIV Compared to Trivalent Egg-based Influenza Vaccine in Healty Adult Volunteers

Conditions
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Influenza

Intervention / Treatment
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* Biological: NBP607QIV
* Biological: Agrippal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults aged 19 to 59 years Those who are able and willing to give written informed consent to study participation and compliance with study instructions after being informed of and understand details of the study If female, at least 2 years after post- menopausal and negative result of urine-human chorionic gonadotropin (HCG) test at screening Exclusion Criteria: Those with hypersensitivity to any component of the study medication or chemically related substances, such as allergy to eggs or egg products Those with Immunodeficiency disease Those with history of hypersensitivity when vaccination, such as Guillain-Barre syndrome Those who are contraindicated for intramuscular injection due to thrombocytopenia or coagulopathy Those who experienced fever (>38°C) within the past 24 hours or any acute respiratory infection Those with history of treatment with any of Immunosuppressants or Immunomodulators within the past 3 months Those with history of receiving blood products or immunoglobulin within the past 3 months Those with history of influenza vaccination within the past 6 months Those who received another vaccine within the past 1 month or have plan to receive another vaccine within 1 months following the study vaccination Those with history of participation on another clinical trial within 1 month prior to the study vaccination Those with history of blood donation within 1 week prior to the study vaccination or plan of blood donation within 7 days following the study vaccination Those with any chronic diseases that interfere with the clinical trial or malignant tumors Pregnant or breastfeeding Those with 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: 19 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: NBP607QIV<br>1 dose of 0.5mL by Intramuscular injection | Biological: NBP607QIV<br>* Purified inactivated influenza virus surface antigens of four strains(quadrivalent)<br>|
| Active Comparator: Agrippal<br>1 dose of 0.5mL by Intramuscular injection | Biological: Agrippal<br>* Influenza virus surface antigens of three strains(trivalent)<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. Comparisons within each group between pre-/post- vaccination were summarized and presented. The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated. | 7 days after vaccination | 
| Incidence rate of solicited systemic AEs | The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated. | 7 days after vaccination | 
| Incidence rate of unsolicited AEs | The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated. | 21 days after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroprotection rate measured by post-vaccination Haemagglutination Inhibition(HI) titer[Immunogenicity] | The proportion of subjects with post-vaccination HI titers of ≥1:40 | 21-28 days after vaccination | 
| Seroconversion rate measured by pre-/post-vaccination HI titerImmunogenicity] | 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 | 
| 9. 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 |