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Influenza, HumanPhase 3NCT02621177

Study of Egg-derived Influenza Vaccine and Cell Culture-derived Influenza Vaccine in Healthy Children and Adolescents

A Phase 3 study testing NBP607 and Agrippal S1 in people with Influenza, Human, 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 is a multi-center, randomized, double-blind Phase III clinical trial. The aim of the study is to describe the immunogenicity and safety of the trivalent cell culture-derived influenza vaccine compared to the trivalent egg-derived influenza vaccine among subjects. Read more about this study

Who is it for?
Ages 6 months to 18 yearsHealthy volunteers can take part
Conditions the study is for
Influenza, Human
What is being tested?
NBP607 and Agrippal S1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
385 participants
Where
No sites listed yet
Study dates
Nov 2013to Jul 2014
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 months to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Healthy children and adolescents aged 6 months to 18 years.
  • Those who was born after normal pregnancy period(37 weeks) for aged 6 months to 2 years.
  • Those whose legally acceptable representative have given written consent to participate in the study and comply with all study requirements.

Who cannot join

  • Subjects who are hypersensitive to any component of vaccine, i.e., eggs, chicken or chicken products.
  • Subjects with immune deficiency disorder.
  • History of 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 or with any acute respiratory infection.
  • Subjects who had received immunosuppressant or immune-modifying drug within 3 months before screening.
Show all 14Show fewer
  • Subjects who had received blood products or immunoglobulin within 3 months before screening.
  • 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 participated in other clinical trial within 4 weeks prior to study vaccination.
  • Subjects who had done blood donation within a week prior to study vaccination or planned blood donation within 7 months after study vaccination.
  • Subjects with clinically significant chronic disease or malignant cancer.
  • Pregnant women, breast-feeding women.
  • Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.

About this study

Official title: A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess the Immunogenicity and Safety of 'NBP607(Trivalent Inactivated Cell Culture-derived Influenza Vaccine)' in Healthy Children and Adolescents Aged 6 Month ~ 18 Years)

This study is a multi-center, randomized, double-blind Phase III clinical trial. The aim of the study is to describe the immunogenicity and safety of the trivalent cell culture-derived influenza vaccine compared to the trivalent egg-derived influenza vaccine among subjects.

Read the detailed description

Subjects are randomly assigned in a 4:1 ratio to NBP607-QIV versus Agrippal S1. 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, Agrippal S1
Medical subject headings
Influenza, Human

What participants receive

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

  • NBP607Biological

    For subjects 6 months to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects 9 to 18 years of age, single intramuscular dose (0.25mL/0.5 mL)

  • Agrippal S1Biological

    For subjects 6 months to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects 9 to 18 years of age, single intramuscular dose (0.25mL/0.5 mL)

Study groups in NCT02621177
Study groupRoleWhat they receive
NBP607ExperimentalTrivalent Inactivated Cell Culture-derived Influenza Vaccine
Receives: Biological: NBP607
Agrippal S1Active comparatorTrivalent Inactivated Egg-derived Influenza Vaccine
Receives: Biological: Agrippal S1

What is being measured

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

  1. CHMP criteria

    Seroprotection rate > 70%, Seroconversion rate > 40%, GMR > 2.5

    Measured: At Day 28 post-vaccination

Secondary outcomes (6)

  1. Immunogenicity in subjects with a pre-vaccination HI antibody titer < 1:80

    Measured: At Day 28 post-vaccination

  2. Immunogenicity compared to control group

    Measured: At Day 28 post-vaccination

  3. Incidence rate of Advers Event (AE)

    Including Solicited Local AE, Solicited Systemic AE, and Unsolicited AE

    Measured: During 7 days post-vaccination for Solicited AE and during 28 days post-vaccination for Unsolicited AE

  4. Incidence rate of Severe Adverse Event (SAE)

    Measured: During 6 months post-vaccination

  5. Vital Sign

    Measured: At Day 0 and at Day 28 post-vaccination

  6. Physical Examination

    Measured: At Day 0 and 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 posted3 Dec 2015 (estimated)
  2. Study startNov 2013
  3. Primary completionMar 2014
  4. Study completionJul 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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
385 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02621177
Sponsor's protocol ID
NBP607_FluC_III_2013
Status last verified
Dec 2015
First submitted
30 Nov 2015
Last updated
3 Dec 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NBP607 and Agrippal S1 in people with Influenza, Human, 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 3 Dec 2015. 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 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?

CHMP criteria (time frame: At Day 28 post-vaccination). 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 NCT02621177.

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 3 Dec 2015.

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