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Influenza, HumanPhase 3NCT03020628

Immunogenicity and Safety of Quadrivalent Influenza Vaccine in Children Aged 6~35 Months

A Phase 3 study testing NBP607-QIV and NBP607-TIV in people with Influenza, Human, run by SK Chemicals Co., Ltd. at 12 sites 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 is a multi-center, randomized, double-blind Phase III Clinical trial. The purpose of this study is to assess the immunogenicity and safety of the quadrivalent cell culture-derived influenza vaccine compare to the trivalent cell culture-derived influenza vaccine in children aged 6~35 months. Read more about this study

Who is it for?
Ages 6 to 35 monthsHealthy volunteers can take part
Conditions the study is for
Influenza, Human
What is being tested?
NBP607-QIV and NBP607-TIV
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
171 participants
Where
12 sitesSouth Korea
Study dates
Oct 2016to Jun 2017
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 months to 35 months
  • Those who was born after normal pregnancy period(37 weeks) for aged 6 months to < 1 year
  • Those whose legally acceptable representative have given written consent to participate in the study and comply with all study requirements.

Who cannot join

  • Subjects with immune deficiency disorder or malignant cancer.
  • History of any hypersensitivity following administration of vaccine or Guillain-Barre syndrome.
  • Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
  • Subjects who experienced fever within 72 hours before vaccination or with the febrile disease(exceeding 38.0℃) on screening day.
  • Subjects who had received immunosuppressant or immune-modifying drug within 3 months before screening.
  • Subjects who had received blood products or immunoglobulin within 3 months before screening.
Show all 11Show fewer
  • Subjects who had received influenza vaccination within 6 months prior to the screening.
  • Subjects who had received other vaccination within a month before screening, or those who had another vaccination scheduled within a month after study vaccination.
  • Subjects who had received any other investigational products within 4 weeks prior to study vaccination.
  • Subjects with clinically significant chronic disease.
  • Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

South Korea12 sites

  • Korea University ANSAN hospital

    Ansan

  • Chungnam National University Hospital

    Daejeon

  • Inje University Ilsan Paik Hospital

    Goyang

  • Gachon University Gil Medical center

    Incheon

  • The Catholic University of Korea, Incheon ST. Mary's Hospital

    Incheon

  • Chonbuk National University Hospital

    Jeonju

  • Asan Medical Center

    Seoul

  • Eulji General Hospital

    Seoul

  • Hallym University Dongtan Sacred Heart Hospital

    Seoul

  • Korea Institute of Radiological and Medical Science

    Seoul

  • Samsung Medical Center

    Seoul

  • Wonju Severance Christian Hospital

    Wŏnju

Other trials in South Korea

About this study

Official title: A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess the Immunogenicity and Safety of 'NBP607-QIV(Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine)' in Children Aged 6~35 Months

This study is a multi-center, randomized, double-blind Phase III Clinical trial. The purpose of this study is to assess the immunogenicity and safety of the quadrivalent cell culture-derived influenza vaccine compare to the trivalent cell culture-derived influenza vaccine in children aged 6~35 months.

Read the detailed description

Subjects are randomly assigned in a 2:1 ratio to NBP607-QIV 0.5mL versus NBP607-TIV 0.25mL. To assess the immunogenicity, antibody levels are evaluated by hemagglutination inhibition(HI) assay from sera obtained at pre-vaccination and 28 days post-vaccination. 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. The serious adverse events are collected during 6 months post-vaccination.

Being tested
NBP607-QIV, NBP607-TIV
Keywords
Influenza Vaccines, Vaccines, Inactivated, Cell Culture-Derived
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

    For subjects 6 months to 35 months of age, Single dose administration, Intra-muscular [* 2 doses for subjects without influenza vaccination history, administered at least 4 weeks apart]

  • NBP607-TIVBiological

    For subjects 6 months to 35 months of age, Single dose administration, Intra-muscular [* 2 doses for subjects without influenza vaccination history, administered at least 4 weeks apart]

Study groups in NCT03020628
Study groupRoleWhat they receive
NBP607-QIV 0.5mLExperimentalQuadrivalent Inactivated Cell Culture-derived Influenza Vaccine
Receives: Biological: NBP607-QIV
NBP607-TIV 0.25mLActive comparatorTrivalent Inactivated Cell Culture-derived Influenza Vaccine
Receives: Biological: NBP607-TIV

What is being measured

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

  1. HI[hemagglutination Inhibition] derived parameters: Seroprotection rate(a lower bound of 95% CI) > 70%

    Seroprotection rate is the proportion of subjects achieving a post-vaccination HI titer ≥ 1:40

    Measured: At Day 28 post-vaccination

  2. HI[hemagglutination Inhibition] derived parameters: Seroconversion rate(a lower bound of 95% CI) > 40%

    Seroconversion is defined as a pre-vaccination HI titer of <1:10 with a post-vaccination titer ≥ 1:40, and a significant increase was defined as at least a four fold increase in HI titer

    Measured: At Day 28 post-vaccination

  3. HI[hemagglutination Inhibition] derived parameters: GMR (a lower bound of 95% CI) > 2.5

    GMR [geometric mean ratio, mean fold increase]

    Measured: At Day 28 post-vaccination

Timeline

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

  1. First posted13 Jan 2017 (estimated)
  2. Study startOct 2016
  3. Primary completionMar 2017
  4. Study completionJun 2017

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
171 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03020628
Sponsor's protocol ID
NBP607-QIV_FluC_III_2016
Status last verified
Oct 2017
First submitted
11 Jan 2017
Last updated
1 Nov 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NBP607-QIV and NBP607-TIV in people with Influenza, Human, run by SK Chemicals Co., Ltd. at 12 sites 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 11 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 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites 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?

HI[hemagglutination Inhibition] derived parameters: Seroprotection rate(a lower bound of 95% CI) > 70% (time frame: At Day 28 post-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 NCT03020628.

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 Nov 2017.

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