Clinical trial NCT03893669: Safety, Tolerability and Immunogenicity of an Trivalent Inactivated Cell-Culture Influenza Vaccine in Healthy Adults
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prevention of Influenza
Lead sponsor: SK Chemicals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-03-28
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence rate of solicited local adverse events (AEs)
timeFrame: Within 21 days after vaccination
measure: Incidence rate of solicited systemic AEs
timeFrame: Within 21 days after vaccination
measure: Incidence rate of unsolicited AEs
timeFrame: Within 21 days after vaccination
measure: Pulse rate at each visit
timeFrame: 0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
measure: Blood pressure(systolic/diastolic) at each visit
timeFrame: 0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
measure: Body temperature at each visit
timeFrame: 0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
measure: Rate of normal/abnormal results in Electrocardiogram (ECG) (ventricular rate, PR interval, QRS, QT, and QTc) collected during screening visit and close-out visit
timeFrame: Screening visit(0-14 days prior to vaccination)/close-out visit(21-28 days after vaccination)
measure: Rate of normal/abnormal results in physical examination at each visit
timeFrame: 0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
measure: Rate of normal/abnormal results in clinical laboratory tests(Platelet, Cl, etc.) during screening visit and close-out visit
timeFrame: Screening visit(0-14 days prior to vaccination)/close-out visit(21-28 days after vaccination)
Secondary outcomes:
measure: Seroconversion rate measured by pre-/post-vaccination Haemagglutination Inhibition (HI) titer[Immunogenicity]
timeFrame: 21-28 days after vaccination
measure: Geometric Mean Ratio (GMR) measured by pre-/post-vaccination HI titer[Immunogenicity]
timeFrame: 21-28 days after vaccination
measure: Seroprotection rate measured by post-vaccination HI titer[Immunogenicity]
timeFrame: 21-28 days after vaccination
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
state: Guro-gu
Study officials:
affiliation: Korea University Guro Hospital
name: Woo Joo Kim, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: