ImmunocompromisedPhase 2NCT01069601
H1N1sw Vaccine in Adult Transplant Recipients
A Phase 2 study testing Focetria (2x H1N1 vaccine with MF59 adjuvants) in people with Immunocompromised, run by HepNet Study House, German Liverfoundation at 1 site in Germany.
Trial summary
The trial investigates the efficacy of the adjuvanted H1N1 influenza vaccine Focetria(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
- What is being tested?
- Focetria (2x H1N1 vaccine with MF59 adjuvants)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteGermany
- Study dates
- Feb 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
- 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
Who cannot join
- Individuals who received any vaccine within 30 days prior to study entry
- Individuals who received a H1N1 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)
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 H1N1 Influenza Vaccine 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 the adjuvanted H1N1 influenza vaccine Focetria(R) in immunocompromised adults who have undergone solid organ or bone marrow transplantation. It is expected that when administered twice the vaccine fulfills all serological efficacy criteria required for the elderly population age 60 years and older.
- Conditions
- Immunocompromised
- Being tested
- Focetria (2x H1N1 vaccine with MF59 adjuvants)
- Keywords
- solid organ transplantation, bone marrow transplantation, adults, adults with solid organ transplantation, adults with bone marrow transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focetria (2x H1N1 vaccine with MF59 adjuvants)Biological
Also called Focetria(R)
7,5µg H1N1sw monovalent vaccine with MF59 adjuvants; two doses 3 weeks apart
| Study group | Role | What they receive |
|---|---|---|
| transplanted adults | Experimental | male and female adults who have previously undergone solid organ transplantation or allogeneic or autologous BMT Receives: Biological: Focetria (2x H1N1 vaccine with MF59 adjuvants) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The adjuvanted H1N1 influenza vaccine, when administered twice in transplanted patients, fulfils all serological efficacy criteria as required for the elderly population (aged 60 and older) according to the respective European guidance documents.
Measured: 42 days
Secondary outcomes (1)
The adjuvanted H1N1 influenza vaccine in transplanted patients, when administered twice, is at least as effective as the adjuvanted H1N1 influenza vaccine in the healthy volunteers after only one administration.
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionApr 2011
- Study completionApr 2012
Why it stopped: End of H1N1 Swine Flu Pandemic
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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- HepNet Study House, German Liverfoundation
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Michael P Manns, Prof, Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01069601
- Sponsor's protocol ID
- 2009-017052-27
- Other IDs
- 200910H1N1MHH, 2009
- Status last verified
- Apr 2012
- First submitted
- 15 Feb 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 H1N1 Influenza Vaccine in Immunocompromised Adults Who Have Undergone Solid Organ Transplantation or Bone Marrow Transplantation and in Age-Matched Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01069601
- Acronym / sponsor ID
- 2009-017052-27
- Conditions
- Immunocompromised
- Keywords
- solid organ transplantation, bone marrow transplantation, adults, adults with solid organ transplantation, adults with bone marrow transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: End of H1N1 Swine Flu Pandemic
- Enrolment
- 13 participants (actual)
- Lead sponsor
- HepNet Study House, German LiverfoundationResearch network
- Study start
- Feb 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 17 Feb 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 the adjuvanted H1N1 influenza vaccine Focetria(R) in immunocompromised adults who have undergone solid organ or bone marrow transplantation. It is expected that when administered twice 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 |
|---|---|---|
| transplanted adults | Experimental | Biological: Focetria (2x H1N1 vaccine with MF59 adjuvants)male and female adults who have previously undergone solid organ transplantation or allogeneic or autologous BMT |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 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
Key exclusion criteria (5 listed)
- Individuals who received any vaccine within 30 days prior to study entry
- Individuals who received a H1N1 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 |
|---|---|---|
| Focetria (2x H1N1 vaccine with MF59 adjuvants)Also: Focetria(R)7,5µg H1N1sw monovalent vaccine with MF59 adjuvants; two doses 3 weeks apart | Biological | transplanted adults |
Primary outcome
The adjuvanted H1N1 influenza vaccine, when administered twice in transplanted patients, fulfils all serological efficacy criteria as required for the elderly population (aged 60 and older) according to the respective European guidance documents.
Time frame: 42 days
1 secondary outcome
The adjuvanted H1N1 influenza vaccine in transplanted patients, when administered twice, is at least as effective as the adjuvanted H1N1 influenza vaccine in the healthy volunteers after only one administration.
Time frame: 42 days
Results and safety
The study was stopped early (reason given: End of H1N1 Swine Flu Pandemic). Results are not available in the source record.
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.
Michael P Manns, Prof principal investigator
Hannover Medical School
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 Focetria (2x H1N1 vaccine with MF59 adjuvants) in people with Immunocompromised, 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 3 inclusion and 5 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: stopped early, 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 was stopped early (reason given: End of H1N1 Swine Flu Pandemic). Results are not available in the source record.
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?
The adjuvanted H1N1 influenza vaccine, when administered twice in transplanted patients, fulfils all serological efficacy criteria as required for the elderly population (aged 60 and older) according to the respective European guidance documents. (time frame: 42 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.