Prevention of Influenza
Conditions
Brief summary
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
1. Assessment of Safety 2. Assessment of Immunogenicity 3. Estimated Enrollment: 100
Interventions
Sponsors
SK Chemicals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 59 Years
Healthy volunteers
Yes
Inclusion criteria
1. 20 to \<60 years of age 2. able and willing to give written informed consent prior to study entry 3. if female, at least 2 years after post- menopausal and negative result of urine-human chorionic gonadotropin (HCG) test at screening
Exclusion criteria
1. hypersensitivity to any component of the study medication or chemically related substances, such as allergy to eggs or egg products 2. Immunodeficiency disease 3. history of hypersensitivity when vaccination, such as Guillain-Barre syndrome 4. thrombocytopenia or Coagulation disorders 5. experienced fever (\>37.5°C) within the past 24 hours or any acute respiratory infection 6. receipt of Immunosuppressants or Immunomodulators within the past 3 months 7. receipt of blood products or immunoglobulin within the past 3 months 8. received influenza vaccine within the past 6 months 9. received another vaccine within the past 1 month or plans vaccination within 1 months following the study vaccination 10. participation on another clinical trial within 1 month prior to the study vaccination 11. history of blood donation within 1 week prior to the study vaccination for plan of blood donation within 7 days following the study vaccination 12. any chronic diseases that interfere with the clinical trial or Malignant tumors 13. pregnant or breastfeeding 14. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of normal/abnormal results in clinical laboratory tests(Platelet, Cl, etc.) during screening visit and close-out visit | Screening visit(0-14 days prior to vaccination)/close-out visit(21-28 days after vaccination) | Comparisons within each group between pre-/post- vaccination were summarized and presented. |
| Body temperature at each visit | 0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination | Comparisons within each group between pre-/post- vaccination were summarized and presented. |
| Rate of normal/abnormal results in Electrocardiogram (ECG) (ventricular rate, PR interval, QRS, QT, and QTc) collected during screening visit and close-out visit | Screening visit(0-14 days prior to vaccination)/close-out visit(21-28 days after vaccination) | Comparisons within each group between pre-/post- vaccination were summarized and presented. |
| Rate of normal/abnormal results in physical examination at each visit | 0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination | Comparisons within each group between pre-/post- vaccination were summarized and presented. |
| Incidence rate of solicited local adverse events (AEs) | Within 21 days after vaccination | 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. |
| Incidence rate of solicited systemic AEs | Within 21 days after vaccination | 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. |
| Incidence rate of unsolicited AEs | Within 21 days after vaccination | 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. |
| Pulse rate at each visit | 0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination | Comparisons within each group between pre-/post- vaccination were summarized and presented. |
| Blood pressure(systolic/diastolic) at each visit | 0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination | Comparisons within each group between pre-/post- vaccination were summarized and presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Ratio (GMR) measured by pre-/post-vaccination HI titer[Immunogenicity] | 21-28 days after vaccination | The mean increase in geometric mean HI titer |
| Seroprotection rate measured by post-vaccination HI titer[Immunogenicity] | 21-28 days after vaccination | The proportion of subjects with post-vaccination HI titers of ≥1:40 |
| Seroconversion rate measured by pre-/post-vaccination Haemagglutination Inhibition (HI) titer[Immunogenicity] | 21-28 days after vaccination | 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 |
Countries
South Korea
Outcome results
None listed