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Influenza InfectionPhase 3NCT01201902

A Study to Evaluate the Safety and Immunogenicity of an Inactivated Split-virion Influenza A(H1N1) Vaccine

A Phase 3 study testing Adjuvanted influenza A(H1N1) vaccine and un-adjuvanted influenza A(H1N1) vaccine in people with Influenza Infection, run by Green Cross Corporation.

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 assess the safety and the body's immune response to an experimental H1N1 influenza vaccine in healthy adult and elderly populations. The study will enroll up to 590 healthy adults ages 18 and older with no history of H1N1 infection or vaccination. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Influenza Infection
What is being tested?
Adjuvanted influenza A(H1N1) vaccine and un-adjuvanted influenza A(H1N1) vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
592 participants
Where
No sites listed yet
Study dates
Oct 2009to Jul 2010
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy adults age 18 and older.
  • Are able to understand and comply with planned study procedures.
  • Provide written informed consent prior to initiation of any study procedures.

Who cannot join

  • Have a known allergy to eggs, chickens or other components of the vaccine(including MF59).
  • Have immunosuppression including immunodeficiency disease.
  • Have a history of Guillain-Barre Syndrome.
  • Have a diagnosis of thrombocytopenia.
  • Have a chronic disease that the investigator believes may interfere with successful completion of the study. (Excluding regulating hypertension)
  • Hemophilia Patients or Are receiving anti-coagulating agents. Low-dose aspirin (100mg/day) purpose of prevention is allowed.
Show all 15Show fewer
  • Are receiving anti-viral agents.
  • Have an acute fever, a temperature greater than 38℃(100.4 degrees Fahrenheit) within 72 hours of vaccination or Have a symptom of acute febrile illness within 14 days prior to vaccination in this study.
  • Received below agents or expect to receive agents within following periods. A. Have immunosuppression therapy, radiotherapy, use of high-dose glucocorticoids or prednisolone(≥15mg/day) within 6 months prior to vaccination in this study.Inhaled, nasal and topical steroids are allowed) B. Have a history of receiving immunoglobulin or other blood product within 3 months prior to vaccination in this study.
  • Received an experimental agent within 1 month prior to vaccination in this study.
  • Received any vaccines(live licensed and inactivated licensed) within 1 month prior to vaccination in this study. (Excluding seasonal Influenza vaccine)
  • Those who are not eligible to receive vaccine injection in the arm deltoid muscle.
  • Pregnant females, Nursing mom, Those women who have a chance to become pregnant, but not taking a proper contraception.
  • Not agree to abstain from drinking following 7 days of vaccination.
  • Have any condition (clinically regardful medical or psychological condition) that would, in the opinion of the site investigator, render them unable to meet the requirements of the protocol.

About this study

Official title: Randomized, Open, Clinical Study to Evaluate the Safety and Immunogenicity of an Inactivated Split-virion Influenza A(H1N1) Vaccine GC1116 With Adjuvant in Healthy Adults

The purpose of this study is to assess the safety and the body's immune response to an experimental H1N1 influenza vaccine in healthy adult and elderly populations. The study will enroll up to 590 healthy adults ages 18 and older with no history of H1N1 infection or vaccination. 354 individuals will be 18-64 years old, and the other 236 will be greater than or equal to 65 years of age.

Read the detailed description

▶ Immunogenicity(Efficacy) Outcome Measures : Hemagglutination inhibition assay

  1. Proportion of subjects, stratified by group, with seroconversion to HI antibody
  2. Proportion of subjects, stratified by group, achieving a serum hemagglutination inhibition assay(HIA) antibody titer of 1:40 greater against the influenza H1N1 2009 virus
  3. GMT(Geometric Mean Titer) and GMR(Geometric Mean Ratio) measuring by HIA antibody titer
  • Safety Outcome Measures :
  1. Solicited adverse events(Day 0 ~ 6, Day 21 ~ 27) 2. Unsolicited adverse events(Day 0 ~ 42) 3. Adverse events(Day 21 ~ 6 months)
Being tested
Adjuvanted influenza A(H1N1) vaccine, un-adjuvanted influenza A(H1N1) vaccine

What participants receive

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

  • Adjuvanted influenza A(H1N1) vaccineBiological

    Also called Split-virion vaccine

    0.25ml, Intramuscular on Day 0 and 21

  • Adjuvanted influenza A(H1N1) vaccineBiological

    Also called Split-virion vaccine

    0.5ml, Intramuscular on Day 0 and 21

  • un-adjuvanted influenza A(H1N1) vaccineBiological

    Also called Split-virion vaccine

    0.5ml, Intramuscular on Day 0 and 21

  • Adjuvanted influenza A(H1N1) vaccineBiological

    Also called Split-virion vaccine

    0.25ml, Intramuscular on Day 0 and 21

  • Adjuvanted influenza A(H1N1) vaccineBiological

    Also called Split-virion vaccine

    0.5ml, Intramuscular on Day 0 and 21

Study groups in NCT01201902
Study groupRoleWhat they receive
Group 1 : Low dose with adjuvantExperimentalGroup 1: 18 ~ 64 years old subjects
Receives: Biological: Adjuvanted influenza A(H1N1) vaccine
Group 1: High dose with adjuvantExperimentalGroup 1: 18 ~ 64 years old subjects
Receives: Biological: Adjuvanted influenza A(H1N1) vaccine
Group1 : Plain vaccineActive comparatorGroup 1: 18 ~ 64 years old subjects
Receives: Biological: un-adjuvanted influenza A(H1N1) vaccine
Group 2 : Low dose with adjuvantExperimentalGroup 2: greater than or equal to 65 years of age
Receives: Biological: Adjuvanted influenza A(H1N1) vaccine
Group 2 : high dose with adjuvantExperimentalGroup 2: greater than or equal to 65 years of age
Receives: Biological: Adjuvanted influenza A(H1N1) vaccine

What is being measured

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

  1. HI antibody responses after 1 and/or 2 vaccinations

    Measured: 21 days after vaccination

Secondary outcomes (1)

  1. Solicited local & general AE, Unsolicited AE, AE until 6 months after last vaccination

    Measured: the date of vaccination until 6 days after vaccination, 42days after first vaccination, 6 months after last 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 Sep 2010 (estimated)
  2. Study startOct 2009
  3. Primary completionDec 2009
  4. Study completionJul 2010

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
Single blind
Who is masked
Participant
Enrolment
592 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01201902
Sponsor's protocol ID
GC1116
Other IDs
임상제도과 - 649호(2009.9.28)
Status last verified
Sep 2010
First submitted
13 Sep 2010
Last updated
20 Sep 2010
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Adjuvanted influenza A(H1N1) vaccine and un-adjuvanted influenza A(H1N1) vaccine in people with Influenza Infection, run by Green Cross Corporation.

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 15 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 20 Sep 2010. 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?

HI antibody responses after 1 and/or 2 vaccinations (time frame: 21 days after 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 NCT01201902.

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 20 Sep 2010.

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