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InfluenzaPhase 1/2NCT03826719

Safety, Tolerability and Immunogenicity of NBP607QIV in Healthy Adult Volunteers

A Phase 1/2 study testing NBP607QIV and Agrippal in people with Influenza, run by SK Chemicals Co., Ltd..

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

This study assesses safety, tolerability and immunogenicity of NBP607QIV to Agrippal which are indicated for active immunization for the prevention of influenza disease. Read more about this study

Who is it for?
Ages 19 to 59 yearsHealthy volunteers can take part
Conditions the study is for
Influenza
What is being tested?
NBP607QIV 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
No sites listed yet
Study dates
17 Feb 2014to 28 Mar 2014
Phase
Phase 1/2
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 19 to 59 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy adults aged 19 to 59 years
  • 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
  • If female, at least 2 years after post- menopausal and negative result of urine-human chorionic gonadotropin (HCG) test at screening

Who cannot join

  • Those with hypersensitivity to any component of the study medication or chemically related substances, such as allergy to eggs or egg products
  • Those with Immunodeficiency disease
  • Those with history of hypersensitivity when vaccination, such as Guillain-Barre syndrome
  • Those who are contraindicated for intramuscular injection due to thrombocytopenia or coagulopathy
  • Those who experienced fever (>38°C) within the past 24 hours or any acute respiratory infection
  • Those with history of treatment with any of Immunosuppressants or Immunomodulators within the past 3 months
Show all 14Show fewer
  • Those with history of receiving blood products or immunoglobulin within the past 3 months
  • Those with history of influenza vaccination within the past 6 months
  • Those who received another vaccine within the past 1 month or have plan to receive another vaccine within 1 months following the study vaccination
  • Those with history of participation on another clinical trial within 1 month prior to the study vaccination
  • 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
  • Those with any chronic diseases that interfere with the clinical trial or malignant tumors
  • Pregnant or breastfeeding
  • 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.

About this study

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

This study assesses safety, tolerability and immunogenicity of NBP607QIV to Agrippal which are indicated for active immunization for the prevention of influenza disease.

Read the 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.

Conditions
Influenza
Being tested
NBP607QIV, Agrippal
Medical subject headings
Influenza, Human

What participants receive

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

  • NBP607QIVBiological

    Purified inactivated influenza virus surface antigens of four strains(quadrivalent)

  • AgrippalBiological

    Influenza virus surface antigens of three strains(trivalent)

Study groups in NCT03826719
Study groupRoleWhat they receive
NBP607QIVExperimental1 dose of 0.5mL by Intramuscular injection
Receives: Biological: NBP607QIV
AgrippalActive comparator1 dose of 0.5mL by Intramuscular injection
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.

    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.

    Measured: 7 days after vaccination

  2. Incidence rate of solicited systemic AEs

    The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated.

    Measured: 7 days after vaccination

  3. Incidence rate of unsolicited AEs

    The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated.

    Measured: 21 days after vaccination

Secondary outcomes (3)

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

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

    Measured: 21-28 days after vaccination

  2. Seroconversion rate measured by pre-/post-vaccination HI titerImmunogenicity]

    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

  3. 9. 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

Timeline

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

  1. First posted1 Feb 2019
  2. Study start17 Feb 2014
  3. Primary completion28 Mar 2014
  4. Study completion28 Mar 2014

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 1/2
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
NCT03826719
Sponsor's protocol ID
NBP607QIV_Flu_I_2013
Status last verified
Jan 2019
First submitted
31 Jan 2019
Last updated
1 Feb 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing NBP607QIV and Agrippal in people with Influenza, run by SK Chemicals Co., Ltd..

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 1 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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: 7 days after vaccination). The study lists 3 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 NCT03826719.

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 1 Feb 2019.

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