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

Primary Purpose

Prevention of Influenza

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
NBP607
Agrippal
Sponsored by
SK Chemicals Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prevention of Influenza

Eligibility Criteria

20 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Korea University Guro Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

NBP607 0.5ml

Agrippal 0.5ml

Outcomes

Primary Outcome Measures

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.
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.
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.
Pulse rate at each visit
Comparisons within each group between pre-/post- vaccination were summarized and presented.
Blood pressure(systolic/diastolic) at each visit
Comparisons within each group between pre-/post- vaccination were summarized and presented.
Body temperature at each visit
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
Comparisons within each group between pre-/post- vaccination were summarized and presented.
Rate of normal/abnormal results in physical examination at each visit
Comparisons within each group between pre-/post- vaccination were summarized and presented.
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.

Secondary Outcome Measures

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
Geometric Mean Ratio (GMR) measured by pre-/post-vaccination HI titer[Immunogenicity]
The mean increase in geometric mean HI titer
Seroprotection rate measured by post-vaccination HI titer[Immunogenicity]
The proportion of subjects with post-vaccination HI titers of ≥1:40

Full Information

First Posted
December 12, 2012
Last Updated
March 25, 2019
Sponsor
SK Chemicals Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03893669
Brief Title
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

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SK Chemicals Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
Assessment of Safety Assessment of Immunogenicity Estimated Enrollment: 100

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prevention of Influenza

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
NBP607 0.5ml
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Agrippal 0.5ml
Intervention Type
Biological
Intervention Name(s)
NBP607
Intervention Description
1 dose, 0.5ml, Intramuscular (IM) injection
Intervention Type
Biological
Intervention Name(s)
Agrippal
Intervention Description
1 dose, 0.5ml, Intramuscular (IM) injection
Primary Outcome Measure Information:
Title
Incidence rate of solicited local adverse events (AEs)
Description
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.
Time Frame
Within 21 days after vaccination
Title
Incidence rate of solicited systemic AEs
Description
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.
Time Frame
Within 21 days after vaccination
Title
Incidence rate of unsolicited AEs
Description
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.
Time Frame
Within 21 days after vaccination
Title
Pulse rate at each visit
Description
Comparisons within each group between pre-/post- vaccination were summarized and presented.
Time Frame
0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
Title
Blood pressure(systolic/diastolic) at each visit
Description
Comparisons within each group between pre-/post- vaccination were summarized and presented.
Time Frame
0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
Title
Body temperature at each visit
Description
Comparisons within each group between pre-/post- vaccination were summarized and presented.
Time Frame
0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
Title
Rate of normal/abnormal results in Electrocardiogram (ECG) (ventricular rate, PR interval, QRS, QT, and QTc) collected during screening visit and close-out visit
Description
Comparisons within each group between pre-/post- vaccination were summarized and presented.
Time Frame
Screening visit(0-14 days prior to vaccination)/close-out visit(21-28 days after vaccination)
Title
Rate of normal/abnormal results in physical examination at each visit
Description
Comparisons within each group between pre-/post- vaccination were summarized and presented.
Time Frame
0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination
Title
Rate of normal/abnormal results in clinical laboratory tests(Platelet, Cl, etc.) during screening visit and close-out visit
Description
Comparisons within each group between pre-/post- vaccination were summarized and presented.
Time Frame
Screening visit(0-14 days prior to vaccination)/close-out visit(21-28 days after vaccination)
Secondary Outcome Measure Information:
Title
Seroconversion rate measured by pre-/post-vaccination Haemagglutination Inhibition (HI) titer[Immunogenicity]
Description
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
Time Frame
21-28 days after vaccination
Title
Geometric Mean Ratio (GMR) measured by pre-/post-vaccination HI titer[Immunogenicity]
Description
The mean increase in geometric mean HI titer
Time Frame
21-28 days after vaccination
Title
Seroprotection rate measured by post-vaccination HI titer[Immunogenicity]
Description
The proportion of subjects with post-vaccination HI titers of ≥1:40
Time Frame
21-28 days after vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Woo Joo Kim, Ph.D.
Organizational Affiliation
Korea University Guro Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea University Guro Hospital
City
Seoul
State/Province
Guro-gu
ZIP/Postal Code
153-703
Country
Korea, Republic of

12. IPD Sharing Statement

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

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