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OpenTrials
Completed

NCT Number: NCT03893669

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

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

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Key information

Conditions

Prevention of Influenza

Age range

20 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Korea University Guro Hospital

Seoul, Guro-gu, 153-703, South Korea

About this study

  • Assessment of Safety
  • Assessment of Immunogenicity
  • Estimated Enrollment: 100

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NBP607

Biological

1 dose, 0.5ml, Intramuscular (IM) injection

Agrippal

Biological

1 dose, 0.5ml, Intramuscular (IM) injection

Primary outcomes

  1. Incidence rate of solicited local adverse events (AEs)

    Time frame: Within 21 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.

  2. Incidence rate of solicited systemic AEs

    Time frame: Within 21 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.

  3. Incidence rate of unsolicited AEs

    Time frame: Within 21 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.

  4. Pulse rate at each visit

    Time frame: 0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination

    Comparisons within each group between pre-/post- vaccination were summarized and presented.

  5. Blood pressure(systolic/diastolic) at each visit

    Time frame: 0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination

    Comparisons within each group between pre-/post- vaccination were summarized and presented.

  6. Body temperature at each visit

    Time frame: 0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination

    Comparisons within each group between pre-/post- vaccination were summarized and presented.

  7. Rate of normal/abnormal results in Electrocardiogram (ECG) (ventricular rate, PR interval, QRS, QT, and QTc) collected during screening visit and close-out visit

    Time frame: Screening visit(0-14 days prior to vaccination)/close-out visit(21-28 days after vaccination)

    Comparisons within each group between pre-/post- vaccination were summarized and presented.

  8. Rate of normal/abnormal results in physical examination at each visit

    Time frame: 0-14 days prior to vaccination/day of vaccination/3-7 days after vaccination/21-28 days after vaccination

    Comparisons within each group between pre-/post- vaccination were summarized and presented.

  9. Rate of normal/abnormal results in clinical laboratory tests(Platelet, Cl, etc.) during screening visit and close-out visit

    Time frame: Screening visit(0-14 days prior to vaccination)/close-out visit(21-28 days after vaccination)

    Comparisons within each group between pre-/post- vaccination were summarized and presented.

Secondary outcomes

  1. Seroconversion rate measured by pre-/post-vaccination Haemagglutination Inhibition (HI) titer[Immunogenicity]

    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

  2. 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

  3. Seroprotection rate measured by post-vaccination HI titer[Immunogenicity]

    Time frame: 21-28 days after vaccination

    The proportion of subjects with post-vaccination HI titers of ≥1:40

Sponsors and collaborators

Lead sponsor

SK Chemicals Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 28, 2019
Registry last updated
Mar 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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