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Safety, Tolerability and Immunogenicity of NBP607QIV in Healthy Adult Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03826719
Recruitment Status : Completed
First Posted : February 1, 2019
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
SK Chemicals Co., Ltd.

Tracking Information
First Submitted Date  ICMJE January 31, 2019
First Posted Date  ICMJE February 1, 2019
Last Update Posted Date February 1, 2019
Actual Study Start Date  ICMJE February 17, 2014
Actual Primary Completion Date March 28, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2019)
  • Incidence rate of solicited local adverse events(AEs) [ Time Frame: 7 days after vaccination ]
    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 [ Time Frame: 7 days after vaccination ]
    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 [ Time Frame: 21 days after vaccination ]
    The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2019)
  • Seroprotection rate measured by post-vaccination Haemagglutination Inhibition(HI) titer[Immunogenicity] [ Time Frame: 21-28 days after vaccination ]
    The proportion of subjects with post-vaccination HI titers of ≥1:40
  • Seroconversion rate measured by pre-/post-vaccination HI titerImmunogenicity] [ Time Frame: 21-28 days after vaccination ]
    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] [ Time Frame: 21-28 days after vaccination ]
    The mean increase in geometric mean HI titer
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability and Immunogenicity of NBP607QIV in Healthy Adult Volunteers
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Influenza
Intervention  ICMJE
  • Biological: NBP607QIV
    Purified inactivated influenza virus surface antigens of four strains(quadrivalent)
  • Biological: Agrippal
    Influenza virus surface antigens of three strains(trivalent)
Study Arms  ICMJE
  • Experimental: NBP607QIV
    1 dose of 0.5mL by Intramuscular injection
    Intervention: Biological: NBP607QIV
  • Active Comparator: Agrippal
    1 dose of 0.5mL by Intramuscular injection
    Intervention: Biological: Agrippal
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 31, 2019)
100
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 28, 2014
Actual Primary Completion Date March 28, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 59 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03826719
Other Study ID Numbers  ICMJE NBP607QIV_Flu_I_2013
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party SK Chemicals Co., Ltd.
Study Sponsor  ICMJE SK Chemicals Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Woo Joo Kim, MD, PhD Korea University Guro Hospital
PRS Account SK Chemicals Co., Ltd.
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP