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Influenza, HumanPhase 3NCT02344134

Study of Egg-derived Influenza Vaccine and Cell Culture-derived Influenza Vaccine in Adult and Elderly Subjects

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

The purpose of this study is to describe the immunogenicity and safety of the cell culture-derived influenza vaccine compared with the egg-derived influenza vaccine among subjects. Read more about this study

Who is it for?
Ages 19 years and olderHealthy 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
1,155 participants
Where
No sites listed yet
Study dates
Sep 2013to May 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 19 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy adults aged 19 years or older.
  • The subjects who give written consent to participate in the study voluntarily and are able to comply with all study requirements.
  • If female and capable of bearing children,subject has a negative urine pregnancy test result on screening and agrees to employ adequate birth control measures through the study period.

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 24 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 Adults and Elderly Subjects

The purpose of this study is to describe the immunogenicity and safety of the cell culture-derived influenza vaccine compared with the egg-derived influenza vaccine among subjects.

To describe the immunogenicity, antibody levels are evaluated by hemagglutination inhibition(HI) assay from sera obtained pre-vaccination and 21 days post-vaccination.

To describe the safety, the time of onset and duration of local and systemic solicited adverse events are assessed and reported. Unsolicited adverse events and serious adverse events are collected and categorized throughout the study period.

Read the detailed description

This is a multi-center, randomized, double-blind study in healthy adult and elderly subjects. Subjects receive a single dose of one of the influenza vaccine formulations and provide blood samples for immunogenicity assessment.

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

    0.5 mL, intramuscular, a single dose

  • Agrippal S1Biological

    0.5 mL, intramuscular, a single dose

Study groups in NCT02344134
Study groupRoleWhat they receive
NBP607Experimentalcell culture-derived trivalent inactivated subunit influenza vaccine
Receives: Biological: NBP607
Agrippal S1Active comparatoregg-derived trivalent inactivated subunit influenza vaccine
Receives: Biological: Agrippal S1

What is being measured

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

  1. Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigen

    • Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Post-Vaccination.
    • Percentage of Participants Achieving Seroconversion at Day 21 Post-Vaccination With Influenza Vaccine.
    • Pre- and Post- Vaccination Geometric Mean Ratio (GMR)

    Measured: Day 0 and Day 21 post-vaccination

Secondary outcomes (10)

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

    Measured: Day 0 and Day 21 post-vaccination

  2. Immunogenicity compared to control group

    Measured: Day 21 post vaccination, 6 months post vaccination

  3. Long-term Immunogenicity

    Measured: 6 months post-vaccination

  4. Percentage of participants with Solicited Local Adverse Event (AE)

    Measured: During 7 days post-vaccination

  5. Percentage of participants with Solicited Systemic Adverse Event (AE)

    Measured: During 7 days post-vaccination

  6. Percentage of participants with Unsolicited Adverse Event (AE)

    Measured: During 21 days post-vaccination

  7. Percentage of participants with Severe Adverse Event (SAE)

    Measured: During 6 months post-vaccination

  8. Vital Sign

    Body Temperature, Blood Pressure(SBP/DBP), Pulse

    Measured: Day 0 and Day 21 post vaccination

  9. Physical Examination

    inspection, palpation (feel), percussion (tap to determine resonance characteristics), and auscultation (listen)

    Measured: Day 0 and Day 21 post vaccination

  10. Clinical Laboratory Tests

    Blood test(CBC, Coagulation, Chemistry), Urinalysis

    Measured: Day 0 and Day 21 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 posted22 Jan 2015 (estimated)
  2. Study startSep 2013
  3. Primary completionNov 2013
  4. Study completionMay 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
1,155 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02344134
Sponsor's protocol ID
NBP607_FluA_III_2013
Status last verified
Dec 2014
First submitted
24 Dec 2014
Last updated
22 Jan 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Song JY, Cheong HJ, Lee J, Woo HJ, Wie SH, Lee JS, Kim SW, Noh JY, Choi WS, Kim H, Kim KH, Kim WJ. Immunogenicity and safety of a cell culture-derived inactivated trivalent influenza vaccine (NBP607): A randomized, double-blind, multi-center, phase 3 clinical trial. Vaccine. 2015 Oct 5;33(41):5437-5444. doi: 10.1016/j.vaccine.2015.08.030. Epub 2015 Aug 24.

    PubMed 26314625

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 22 Jan 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?

Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigen (time frame: Day 0 and Day 21 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 NCT02344134, which also lists 1 linked publication.

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 22 Jan 2015.

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