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InfluenzaPhase 3NCT03704740

Immunogenicity and Safety of NBP607-QIV Compared to Agrippal in Children Aged 6 to 35 Months

A Phase 3 study testing NBP607-QIV and Agrippal in people with Influenza, run by SK Bioscience 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

This study assesses immunogenicity and safety of NBP607-QIV to Agrippal which are indicated for active immunization for the prevention of influenza disease. Total of 675 subjects or above (450 subjects for NBP607-QIV arm and 225 subjects for Agrippal arm) of 6 to 35 months of age are enrolled, and each subject is… Read more about this study

Who is it for?
Ages 6 to 35 monthsHealthy volunteers can take part
Conditions the study is for
Influenza
What is being tested?
NBP607-QIV and Agrippal
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
676 participants
Where
1 siteSouth Korea
Study dates
25 Oct 2018to 12 Jul 2019
Phase
Phase 3
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 6 to 35 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Children aged 6 to 35 months
  • Those who were normal gestational age at birth (for children aged 6 months to <1 year)
  • Those who have provided written informed consent to study participation and compliance with study instructions after being informed of and understand details of the study

Who cannot join

  • Those with any immunodeficiency disease or malignancy
  • Those with hypersensitivity to vaccination
  • Those who are contraindicated for intramuscular injection due to thrombocytopenia or other coagulopathy
  • Those with history of treatment with any of immunosuppressants or immunoregulators within 12 weeks prior to screening
  • Those with history of receiving blood product or treatment with immunoglobulin within 24 weeks prior to screening
  • Those with history of influenza vaccination within 24 weeks prior to screening
  • Those with any severe chronic conditions that interfere with study participation

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • SK Bioscience

    Gyeonggi-do, Seongnam-si, 13494

Other trials in South Korea

About this study

Official title: A Multinational, Comparative Phase III Clinical Trial to Assess the Efficacy (Immunogenicity) and Safety of NBP607-QIV (0.5 mL) (Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine) in Children Aged 6 to 35 Months

This study assesses immunogenicity and safety of NBP607-QIV to Agrippal which are indicated for active immunization for the prevention of influenza disease. Total of 675 subjects or above (450 subjects for NBP607-QIV arm and 225 subjects for Agrippal arm) of 6 to 35 months of age are enrolled, and each subject is administered with single or two doses of vaccines depending on previous vaccination history.

Read the detailed description

This is a multi-national, multi-center, randomized, double blinded, parallel-group study to assess the immunogenicity and safety of NBP607-QIV compared to Agrippal which are indicated for active immunization for the the prevention of influenza disease. Total of 675 subjects or above (450 subjects for NBP607-QIV arm and 225 subjects for Agrippal arm) of 6 to 35 months of age are enrolled. Each subject is administered with single or two doses of vaccines depending on previous vaccination history, and randomly assigned in 2:1 ratio.

Stratified randomization for trial site and age strata is used to achieve the balance of treatment assignment.

Total of three or five visits are scheduled depeding on dosing schedule. For subjects assigned to single-dose vaccination schedule, blood sampling is conducted for immunogenicity assessment before and 4 weeks after single vaccination at Visit 1 and 3 respectively. Safety is monitored 3 days, 4 weeks after vaccination through Visit 2* and 3 (* telephone contact). For subjects assigned to two-dose vaccination schedule, blood sampling is conducted before first vaccination and 4 weeks after second vaccination at Visit 1 and Visit 5 respectively. Safety is monitored 3 days, 4 weeks after each vaccination through Visit 2*, 3, 4*, and 5 (* telephone contact)

Conditions
Influenza
Being tested
NBP607-QIV, 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.

  • NBP607-QIVBiological

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

  • AgrippalBiological

    Influenza virus surface antigens of three strains (trivalent)

Study groups in NCT03704740
Study groupRoleWhat they receive
NBP607-QIVExperimentalOne or two doses of 0.5mL of NBP607-QIV by intramuscular injection
Receives: Biological: NBP607-QIV
AgrippalActive comparatorOne or two doses of 0.25mL of Agrippal by intramuscular injection
Receives: Biological: Agrippal

What is being measured

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

  1. Post-vaccination GMT(Geometric Mean Titer) by HI(Hemagglutination-inhibition) assay for the common strains (A/H1N1, A/H3N2, and B/Victoria)

    Post-vaccination GMT will be adjusted for pre-vaccination titer

    Measured: 4 weeks after last IP(Investigational Product) vaccination

  2. Seroconversion rate by HI assay for the common strains (A/H1N1, A/H3N2, and B/Victoria)

    Seroconversion rate is defined as the proportion of subjects who meet either of the following criteria:

    1. Post-vaccination HI titer of ≥1:40 for subjects with pre-vaccination HI titer of <1:10
    2. Four-fold increase in post-vaccination HI titer for subjects with pre-vaccination HI titer of ≥1:10

    Measured: 4 weeks after last IP(Investigational Product) vaccination

  3. Seroconversion rate by HI assay for the exclusive strain (B/Yamagata)

    Seroconversion rate is defined as the proportion of subjects who meet either of the following criteria:

    1. Post-vaccination HI titer of ≥1:40 for subjects with pre-vaccination HI titer of <1:10
    2. Four-fold increase in post-vaccination HI titer for subjects with pre-vaccination HI titer of ≥1:10

    Measured: 4 weeks after last IP(Investigational Product) vaccination

  4. GMR(Geometric mean ratio) by HI assay for the exclusive strain (B/Yamagata)

    The fold-rise of the geometric mean HI titer from pre- to post-vaccination

    Measured: 4 weeks after last IP(Investigational Product) vaccination

Secondary outcomes (7)

  1. Seroprotection rate by HI assay for all strains

    Seroprotection rate is defined as the proportion of subjects whose post-vaccination HI titer increased to ≥1:40

    Measured: 4 weeks after last IP(Investigational Product) vaccination

  2. CHMP(Committee for Medicinal Products for Human Use) criteria assessment for the common strains (A/H1N1, A/H3N2, and B/Victoria)

    CHMP criteria for seroconversion rate, GMR(Geometric Mean Ratio) will be assessed

    Measured: 4 weeks after last IP(Investigational Product) vaccination

  3. Consistency of immunogenicity among countries

    Post-vaccination GMT and seroconversion rate for the common strains (A/H1N1, A/H3N2, and B/Victoria), and CHMP criteria for seroconversion rate and GMR for the exclusive strain (B/Yamagata) will be assessed

    Measured: 4 weeks after last IP(Investigational Product) vaccination

  4. Percentage of participants with Adverse Events(AEs)

    Incidence rate of Solicited AE, unsolicited AE, SAE(Serious Adverse Event) will be assessed

    Measured: 7 days for Solicited AE and 4 weeks for Unsolicited AE, SAE after last IP(Investigational Product) vaccination

  5. Vital sign

    Body temperature will be assessed

    Measured: 4 weeks after last IP(Investigational Product) vaccination

  6. Height

    Height in centimeters will be assessed

    Measured: 4 weeks after last IP(Investigational Product) vaccination

  7. Weight

    Weight in kilograms will be assessed

    Measured: 4 weeks after last IP(Investigational Product) vaccination

Timeline

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

  1. First posted15 Oct 2018
  2. Study start25 Oct 2018
  3. Primary completion12 Jul 2019
  4. Study completion12 Jul 2019

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
676 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03704740
Sponsor's protocol ID
NBP607-QIV_005
Status last verified
May 2022
First submitted
10 Oct 2018
Last updated
11 May 2022
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 3 study testing NBP607-QIV and Agrippal in people with Influenza, run by SK Bioscience 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 7 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 11 May 2022. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Post-vaccination GMT(Geometric Mean Titer) by HI(Hemagglutination-inhibition) assay for the common strains (A/H1N1, A/H3N2, and B/Victoria) (time frame: 4 weeks after last IP(Investigational Product) vaccination). The study lists 4 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 NCT03704740.

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 11 May 2022.

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