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Prevention of InfluenzaPhase 1NCT03893669

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

A Phase 1 study testing NBP607 and Agrippal in people with Prevention of Influenza, run by SK Chemicals Co., Ltd. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 20 to 59 yearsHealthy volunteers can take part
Conditions the study is for
Prevention of Influenza
What is being tested?
NBP607 and Agrippal
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteSouth Korea
Study dates
Sep 2012to Nov 2012
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 59 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Korea University Guro Hospital

    Seoul, Guro-gu, 153-703

Other trials in South Korea

About this study

Official 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

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
Being tested
NBP607, Agrippal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NBP607Biological

    1 dose, 0.5ml, Intramuscular (IM) injection

  • AgrippalBiological

    1 dose, 0.5ml, Intramuscular (IM) injection

Study groups in NCT03893669
Study groupRoleWhat they receive
Group 1ExperimentalNBP607 0.5ml
Receives: Biological: NBP607
Group 2Active comparatorAgrippal 0.5ml
Receives: Biological: Agrippal

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: Within 21 days after vaccination

  4. Pulse rate at each visit

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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

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

Secondary outcomes (3)

  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

    Measured: 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

    Measured: 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

    Measured: 21-28 days after vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2019
  2. Study startSep 2012
  3. Primary completionOct 2012
  4. Study completionNov 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03893669
Sponsor's protocol ID
NBP607_Flu_I_2012
Status last verified
Oct 2012
First submitted
12 Dec 2012
Last updated
28 Mar 2019
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NBP607 and Agrippal in people with Prevention of Influenza, run by SK Chemicals Co., Ltd. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence rate of solicited local adverse events (AEs) (time frame: Within 21 days after vaccination). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03893669.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2019.

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