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

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

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

Study Overview

• Status: Completed
• Conditions: Prevention of Influenza
• Intervention / Treatment: Biological: NBP607; Biological: Agrippal

Detailed Description

1. Assessment of Safety
2. Assessment of Immunogenicity
3. Estimated Enrollment: 100

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Guro-gu
    • Seoul, Guro-gu, Korea, Republic of, 153-703
      • Korea University Guro Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 59 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; NBP607 0.5ml	Biological: NBP607; 1 dose, 0.5ml, Intramuscular (IM) injection
Active Comparator: Group 2; Agrippal 0.5ml	Biological: Agrippal; 1 dose, 0.5ml, Intramuscular (IM) injection

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: SK Chemicals Co., Ltd.
• Investigators: Principal Investigator: Woo Joo Kim, Ph.D., Korea University Guro Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: December 12, 2012
• First Submitted That Met QC Criteria: March 25, 2019
• First Posted (Actual): March 28, 2019

Study Record Updates

• Last Update Posted (Actual): March 28, 2019
• Last Update Submitted That Met QC Criteria: March 25, 2019
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: NBP607_Flu_I_2012