Safety, Tolerability and Immunogenicity of NBP607QIV in Healthy Adult Volunteers
Primary Purpose
Influenza
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
NBP607QIV
Agrippal
Sponsored by
About this trial
This is an interventional prevention trial for Influenza
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
NBP607QIV
Agrippal
Arm Description
1 dose of 0.5mL by Intramuscular injection
1 dose of 0.5mL by Intramuscular injection
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.
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.
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.
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.
Secondary Outcome Measures
Seroprotection rate measured by post-vaccination Haemagglutination Inhibition(HI) titer[Immunogenicity]
The proportion of subjects with post-vaccination HI titers of ≥1:40
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
9. Geometric Mean Ratio (GMR) measured by pre-/post-vaccination HI titer[Immunogenicity]
The mean increase in geometric mean HI titer
Full Information
NCT ID
NCT03826719
First Posted
January 31, 2019
Last Updated
January 31, 2019
Sponsor
SK Chemicals Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03826719
Brief Title
Safety, Tolerability and Immunogenicity of NBP607QIV in Healthy Adult Volunteers
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
February 17, 2014 (Actual)
Primary Completion Date
March 28, 2014 (Actual)
Study Completion Date
March 28, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SK Chemicals Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NBP607QIV
Arm Type
Experimental
Arm Description
1 dose of 0.5mL by Intramuscular injection
Arm Title
Agrippal
Arm Type
Active Comparator
Arm Description
1 dose of 0.5mL by Intramuscular injection
Intervention Type
Biological
Intervention Name(s)
NBP607QIV
Intervention Description
Purified inactivated influenza virus surface antigens of four strains(quadrivalent)
Intervention Type
Biological
Intervention Name(s)
Agrippal
Intervention Description
Influenza virus surface antigens of three strains(trivalent)
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.
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.
Time Frame
7 days after vaccination
Title
Incidence rate of solicited systemic AEs
Description
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
7 days after vaccination
Title
Incidence rate of unsolicited AEs
Description
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
21 days after vaccination
Secondary Outcome Measure Information:
Title
Seroprotection rate measured by post-vaccination Haemagglutination Inhibition(HI) titer[Immunogenicity]
Description
The proportion of subjects with post-vaccination HI titers of ≥1:40
Time Frame
21-28 days after vaccination
Title
Seroconversion rate measured by pre-/post-vaccination HI titerImmunogenicity]
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
9. 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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Woo Joo Kim, MD, PhD
Organizational Affiliation
Korea University Guro Hospital
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
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Safety, Tolerability and Immunogenicity of NBP607QIV in Healthy Adult Volunteers
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