ImmunocompromisedPhase 2Fluad TxNCT01258023
Seasonal Flu Vaccine in Adult Transplant Recipients
A Phase 2 study testing Fluad 1x in people with Immunocompromised and Transplanted, run by HepNet Study House, German Liverfoundation at 1 site in Germany.
Trial summary
The trial investigates the efficacy of adjuvanted seasonal influenza including H1N1 Fluad (R) in immunocompromised adults who have undergone solid organ or bone marrow transplantation. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Immunocompromised, Transplanted
- What is being tested?
- Fluad 1x
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2010to Apr 2012
- Phase
- Phase 2
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Transplant Recipients:
- Adult subjects 18-60 years of age who have undergone prior renal, cardiac, liver, lung, or bone marrow transplantation for any reason, more than 3 months prior to enrolment
- Patients able to visit the outpatient clinic with a life expectancy of at least one year
- Patients who receive any immunosuppressive treatment currently taken to prevent organ rejection
- Healthy Adults:
- Adult subjects 18-60 years of age
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- Healthy individuals as determined by medical history, physical assessment and clinical judgment of the investigator
- Within the same age category (+/- 5 years) than the incidental transplanted patient
- Transplant Recipients and Healthy Adults:
- Individuals who are able to comply with all study procedures and are available for all clinic visits scheduled in the study
- Women of child-bearing potential (WOCBP) must have used an acceptable contraceptive method for at least 2 months prior to study entry until 3 weeks after vaccination: Female of childbearing potential is defined as a post onset of menarche or pre-menopausal female capable of becoming pregnant. This does not include females who meet any of the following conditions: (1) menopause at least 2 years earlier, (2) tubal ligation at least 1 year earlier, or (3) total hysterectomy
- Acceptable birth control methods are defined as one or more of the following: Hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring, Barrier (condom with spermicide or diaphragm with spermicide) each and every time during intercourse, Intrauterine device (IUD, Monogamous relationship with vasectomized partner. Partner must have been vasectomized for at least six months prior to the subject's study entry
Who cannot join
- Individuals who received any vaccine within 30 days prior to study entry
- Individuals who received a H1N1 or seasonal influenza vaccination less than 6 months prior to the study
- Influenza diagnosed by a physician within 4 months prior to the study start
- Pregnant or lactating females
- History of an anaphylactic (i.e. life-threatening) reaction to any of the components of the vaccines, including egg and chicken proteins, ovalbumin, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB)
- Subjects who are not able to comprehend and to follow all required study procedures for the whole period of the study
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- History of or any current illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study
- Temperature is ≥ 38 °C or oral temperature ≥ 38.5 °C within 3 days of intended study vaccination
- Administration of parenteral immunoglobulin compound - including HBIg, blood products, and/or plasma derivatives within 6 months prior to Visit 1 or planned during the full length of the study
- HIV infection, as previously determined or reported
- History of progressive or severe neurological disorders (including Guillain-Barré syndrome and convulsions, but excluding febrile convulsions)
- Subjects participating in another clinical trial and / or receiving investigational drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study to Evaluate the Immunogenicity, Safety and Tolerability of a Seasonal Influenza Vaccine Including H1N1 in Immunocompromised Adults Who Have Undergone Solid Organ Transplantation or Bone Marrow Transplantation and in Age-Matched Healthy Volunteers
The trial investigates the efficacy of adjuvanted seasonal influenza including H1N1 Fluad (R) in immunocompromised adults who have undergone solid organ or bone marrow transplantation. It is expected that when administered once the vaccine fulfills all serological efficacy criteria required for the elderly population age 60 years and older.
- Conditions
- Immunocompromised, Transplanted
- Being tested
- Fluad 1x
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluad 1xBiological
15 µg antigen/strain:
- A/California/07/2009 (H1N1) - like strain
- A/Perth/16/2009 (H3N2) - like strain
- B/Brisbane/60/2008- like strain MF59 adjuvant 9.75µg ai 0.5ml
| Study group | Role | What they receive |
|---|---|---|
| transplant recipients | Experimental | Immunocompromised Adults Who Have Undergone Solid Organ Transplantation or Bone Marrow Transplantation Receives: Biological: Fluad 1x |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion and Seroprotection after 21 days
The observed percentage of seroconversion and seroprotection, as well as the observed GMR (measured by HI) in transplanted patients at day 21 will be compared with the thresholds from the guideline for adults aged over 60 (as outlined above). This study is successful, if all three point estimates pass the corresponding efficacy criteria at day 21. For descriptive purpose two-sided 95%-confidence intervals for the rates and the GMR at day 21 will be presented.
Measured: 21 days
Secondary outcomes (3)
comparison of vaccine efficacy in transplanted versus healthy subjects
- The immune response of the H1N1 vaccine is at least as effective in transplanted patients as in the healthy volunteers after one administration. For orientation in the assessment a non-inferiority-margin of 0.45 for the ratio of the geometric mean titers (GMTs) of transplanted patients and age-matched healthy volunteers at day 21 will be used and reflects what can be demonstrated with given sample size.
Measured: 21 and 42 days
assessment of primary and secondary outcomes with the two other strains
The primary and the first main secondary objective will also be evaluated for the other two virus strains (H3N2 and type B) of the trivalent vaccination.
Measured: 21 and 42 days
safety issues as number of participants with adverse events
The safety of the study vaccine will be analyzed based on number of subjects exposed to the vaccine with respect to (1) solicited events within 7 days after injection; and (2) non-solicited adverse events at least 21 days after injection. Unsolicited events will include SAEs, AEIs (e.g. neuritis, convulsions, severe allergic reactions, angioedema, non-infectious encephalitis, vasculitis, Guillain-Barrè syndrome, demyelination, Bell's palsy), all other non-solicited AEs, which are routinely collected including onset of chronic diseases.
Measured: 21 and 42 days and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionFeb 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunocompromisedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- HepNet Study House, German Liverfoundation
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01258023
- Sponsor's protocol ID
- 2010-022871-78
- Acronym
- Fluad Tx
- Status last verified
- Apr 2012
- First submitted
- 18 Nov 2010
- Last updated
- 16 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Evaluate the Immunogenicity, Safety and Tolerability of a Seasonal Influenza Vaccine Including H1N1 in Immunocompromised Adults Who Have Undergone Solid Organ Transplantation or Bone Marrow Transplantation and in Age-Matched Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01258023
- Acronym / sponsor ID
- Fluad Tx / 2010-022871-78
- Conditions
- Immunocompromised, Transplanted
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- HepNet Study House, German LiverfoundationResearch network
- Study start
- Nov 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 10 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The trial investigates the efficacy of adjuvanted seasonal influenza including H1N1 Fluad (R) in immunocompromised adults who have undergone solid organ or bone marrow transplantation. It is expected that when administered once the vaccine fulfills all serological efficacy criteria required for the elderly population age 60 years and older.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| transplant recipients | Experimental | Biological: Fluad 1xImmunocompromised Adults Who Have Undergone Solid Organ Transplantation or Bone Marrow Transplantation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Adult subjects 18-60 years of age who have undergone prior renal, cardiac, liver, lung, or bone marrow transplantation for any reason, more than 3 months prior to enrolment
- Patients able to visit the outpatient clinic with a life expectancy of at least one year
- Patients who receive any immunosuppressive treatment currently taken to prevent organ rejection
- Adult subjects 18-60 years of age
- Healthy individuals as determined by medical history, physical assessment and clinical judgment of the investigator
Key exclusion criteria (12 listed)
- Individuals who received any vaccine within 30 days prior to study entry
- Individuals who received a H1N1 or seasonal influenza vaccination less than 6 months prior to the study
- Influenza diagnosed by a physician within 4 months prior to the study start
- Pregnant or lactating females
- History of an anaphylactic (i.e. life-threatening) reaction to any of the components of the vaccines, including egg and chicken proteins, ovalbumin, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluad 1x15 µg antigen/strain: * A/California/07/2009 (H1N1) - like strain * A/Perth/16/2009 (H3N2) - like strain * B/Brisbane/60/2008- like strain MF59 adjuvant 9.75µg ai 0.5ml | Biological | transplant recipients |
Primary outcome
Seroconversion and Seroprotection after 21 days
Time frame: 21 days
The observed percentage of seroconversion and seroprotection, as well as the observed GMR (measured by HI) in transplanted patients at day 21 will be compared with the thresholds from the guideline for adults aged over 60 (as outlined above). This study is successful, if all three point estimates pass the corresponding efficacy criteria at day 21. For descriptive purpose two-sided 95%-confidence intervals for the rates and the GMR at day 21 will be presented.
3 secondary outcomes
comparison of vaccine efficacy in transplanted versus healthy subjects
Time frame: 21 and 42 days
assessment of primary and secondary outcomes with the two other strains
Time frame: 21 and 42 days
safety issues as number of participants with adverse events
Time frame: 21 and 42 days and 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluad 1x in people with Immunocompromised and Transplanted, run by HepNet Study House, German Liverfoundation at 1 site in Germany.
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 12 inclusion and 12 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 16 Apr 2012. 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 Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Seroconversion and Seroprotection after 21 days (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Apr 2012.