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CompletedNCT03893669Updated Mar 28, 2019

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

A Phase 1 interventional study of NBP607 and Agrippal in Prevention of Influenza, sponsored by SK Chemicals Co., Ltd.. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-28.

Sponsored by SK Chemicals Co., Ltd. · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
20 Years to 59 Years
Sex
All
01

Study summary

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

Read the detailed description
  1. Assessment of Safety
  2. Assessment of Immunogenicity
  3. Estimated Enrollment: 100
02

Conditions studied

  • Prevention of Influenza

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03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 100 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

SK Chemicals Co., Ltd. is the lead sponsor of 53 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 59 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. 20 to \<60 years of age
  2. able and willing to give written informed consent prior to study entry
  3. if female, at least 2 years after post- menopausal and negative result of urine-human chorionic gonadotropin (HCG) test at screening

Exclusion criteria

Exclusion Criteria:

  1. hypersensitivity to any component of the study medication or chemically related substances, such as allergy to eggs or egg products
  2. Immunodeficiency disease
  3. history of hypersensitivity when vaccination, such as Guillain-Barre syndrome
  4. thrombocytopenia or Coagulation disorders
  5. experienced fever (>37.5°C) within the past 24 hours or any acute respiratory infection
  6. receipt of Immunosuppressants or Immunomodulators within the past 3 months
  7. receipt of blood products or immunoglobulin within the past 3 months
  8. received influenza vaccine within the past 6 months
  9. received another vaccine within the past 1 month or plans vaccination within 1 months following the study vaccination
  10. participation on another clinical trial within 1 month prior to the study vaccination
  11. history of blood donation within 1 week prior to the study vaccination for plan of blood donation within 7 days following the study vaccination
  12. any chronic diseases that interfere with the clinical trial or Malignant tumors
  13. pregnant or breastfeeding
  14. 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.
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Group 1

    NBP607 0.5ml

    Biological: NBP607

  • Active comparator
    Group 2

    Agrippal 0.5ml

    Biological: Agrippal

Interventions

  • BiologicalNBP607

    1 dose, 0.5ml, Intramuscular (IM) injection

  • BiologicalAgrippal

    1 dose, 0.5ml, Intramuscular (IM) injection

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Within 21 days after vaccination

  2. Incidence rate of solicited systemic 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.

    Time frame: Within 21 days after vaccination

  3. Incidence rate of unsolicited 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.

    Time frame: Within 21 days after vaccination

  4. Pulse rate at each visit

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

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

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

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

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

  6. Body temperature at each visit

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

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

  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

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

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

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

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

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

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

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

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

Secondary outcomes

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

    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

  2. Geometric Mean Ratio (GMR) measured by pre-/post-vaccination HI titer[Immunogenicity]

    The mean increase in geometric mean HI titer

    Time frame: 21-28 days after vaccination

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

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

    Time frame: 21-28 days after vaccination

07

Study locations

1 site
  • Korea University Guro Hospital
    Seoul, Guro-gu 153-703, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03893669
Lead sponsor
SK Chemicals Co., Ltd.
Responsible party
Sponsor
First posted
Mar 28, 2019
Start date
Sep 2012
Primary completion
Oct 2012
Completion
Nov 2012
Last update
Mar 28, 2019

Study contacts

Woo Joo Kim, Ph.D.
principal investigator · Korea University Guro Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.

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