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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.

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.

Condition or disease Intervention/treatment Phase
Influenza Biological: NBP607QIV Biological: Agrippal Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : February 17, 2014
Actual Primary Completion Date : March 28, 2014
Actual Study Completion Date : March 28, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: NBP607QIV
1 dose of 0.5mL by Intramuscular injection
Biological: NBP607QIV
Purified inactivated influenza virus surface antigens of four strains(quadrivalent)

Active Comparator: Agrippal
1 dose of 0.5mL by Intramuscular injection
Biological: Agrippal
Influenza virus surface antigens of three strains(trivalent)




Primary Outcome Measures :
  1. 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.


  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03826719


Sponsors and Collaborators
SK Chemicals Co., Ltd.
Investigators
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Study Chair: Woo Joo Kim, MD, PhD Korea University Guro Hospital
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Responsible Party: SK Chemicals Co., Ltd.
ClinicalTrials.gov Identifier: NCT03826719    
Other Study ID Numbers: NBP607QIV_Flu_I_2013
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases