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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
SK Chemicals Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza

Eligibility Criteria

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

Inclusion Criteria:

  1. Healthy adults aged 19 to 59 years
  2. 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
  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. Those with hypersensitivity to any component of the study medication or chemically related substances, such as allergy to eggs or egg products
  2. Those with Immunodeficiency disease
  3. Those with history of hypersensitivity when vaccination, such as Guillain-Barre syndrome
  4. Those who are contraindicated for intramuscular injection due to thrombocytopenia or coagulopathy
  5. Those who experienced fever (>38°C) within the past 24 hours or any acute respiratory infection
  6. Those with history of treatment with any of Immunosuppressants or Immunomodulators within the past 3 months
  7. Those with history of receiving blood products or immunoglobulin within the past 3 months
  8. Those with history of influenza vaccination within the past 6 months
  9. Those who received another vaccine within the past 1 month or have plan to receive another vaccine within 1 months following the study vaccination
  10. Those with history of participation on another clinical trial within 1 month prior to the study vaccination
  11. 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
  12. Those with any chronic diseases that interfere with the clinical trial or malignant tumors
  13. Pregnant or breastfeeding
  14. 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

    First Posted
    January 31, 2019
    Last Updated
    January 31, 2019
    Sponsor
    SK Chemicals Co., Ltd.
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    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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