Rheumatoid ArthritisPhase 4NCT01151644
Safety and Efficacy of Anti-Pandemic H1N1 Vaccination in Rheumatic Diseases
A Phase 4 study testing Anti-pandemic H1N1 influenza vaccine in people with Rheumatoid Arthritis and Spondyloarthritis, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The prognosis of rheumatic diseases has improved considerably with development of therapy. However, infections are considered the most important cause of morbidity and mortality in this group of patients. One of the ways to prevent such complications is vaccination. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis, Spondyloarthritis, Systemic Lupus Erythematosus (SLE)
- What is being tested?
- Anti-pandemic H1N1 influenza vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2010to Dec 2010
- Phase
- Phase 4
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Rheumatic diseases according to international criteria of each disorder
Who cannot join
- Previous and confirmed infection by virus A(H1N1)/2009
- History of anaphylatic reaction to egg components
- Acute fever
- Guillain-Barré syndrome, heart failure (classes III or IV), demyelinating disease
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Rheumatology Division of Hospital das Clínicas da Faculdade de Medicina da Universidade de são PAulo
São Paulo, São Paulo
About this study
The prognosis of rheumatic diseases has improved considerably with development of therapy. However, infections are considered the most important cause of morbidity and mortality in this group of patients. One of the ways to prevent such complications is vaccination. In 2009, a new pandemic strain of influenza virus (A/H1N1/2009) has emerged raising major concerns for public health. Patients under immunosuppressive therapy have indication for immunization against influenza virus H1N1. There are, however, concerns about possibility of reactivation of autoimmune diseases, determine adverse events and insufficient immunogenicity in these patients. The lack of studies evaluating the efficacy and safety of the vaccine against influenza A(H1N1)/2009 in these rheumatic patients led to the development of this research. The objectives of this study are to evaluate the humoral response and safety of the vaccine virus A(H1N1)/2009 in immunosuppressed patients with rheumatic diseases compared to healthy controls. We have recruited 400 patients with rheumatoid arthritis, 350 with spondyloarthritis, 1000 with systemic lupus erythematosus (SLE), 150 with dermatomyositis (DM), 100 with mixed connective tissue disease, 150 with systemic vasculitis, 250 with systemic sclerosis (SSc) , 100 with Sjögren's syndrome, 100 with antiphospholipid syndrome, 100 patients with juvenile idiopathic arthritis, 80 with juvenile SLE, and 80 with juvenile DM, followed at our Rheumatology Outpatient Division and Unit Pediatric Rheumatology Children's Institute, HC-FMUSP. The control group was recruited were 200 healthy employees of ICHC-FMUSP. Informed consent was obtained from all participants and the study was approved by the Local Ethical Committee. All subjects were vaccinated against influenza virus A/(H1N1)/2009 (vaccine approved and supplied by Instituto Butantan-São Paulo). Blood samples was collected to measure levels of antibodies inhibiting hemagglutination by influenza virus A (H1N1)/2009 immediately prior to vaccination and 21 to 28 days after vaccination., Participants fulfilled a questionnaire on the immediate side effects of the vaccine. All patients with rheumatoid arthritis, spondyloarthritis, SLE, DM, systemic vasculitis, juvenile idiopathic arthritis, juvenile SLE, and DM were assessed before and 21 days after vaccination for clinical, laboratory parameters of disease activity as well as treatment. Continuous variables will be compared by t-test to evaluate differences between patients with rheumatic diseases versus healthy controls. Differences between categorical variables will be evaluated using the chi-square or Fisher exact test. Statistical significance was set at p<0.05.
- Conditions
- Rheumatoid Arthritis, Spondyloarthritis, Systemic Lupus Erythematosus (SLE), Dermatomyositis (DM), DMixed Connective Tissue Disease, Systemic Vasculitis
- Being tested
- Anti-pandemic H1N1 influenza vaccine
- Keywords
- H1N1 VACCINE, INFLUENZA, RHEUMATIC DISEASES, ANTI-H1N1 IMMUNIZATION
- Medical subject headings
- Arthritis, Rheumatoid, Spondylarthritis, Lupus Erythematosus, Systemic, Dermatomyositis, Systemic Vasculitis, Scleroderma, Systemic, Sjogren's Syndrome, Antiphospholipid Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-pandemic H1N1 influenza vaccineBiological
inactivated, NON-adjuvanted pandemic H1N1 influenza vaccine (A/California/7/2009)
| Study group | Role | What they receive |
|---|---|---|
| VACCINATION OF PATIENTS | Active comparator | Not described Receives: Biological: Anti-pandemic H1N1 influenza vaccine |
| VACCINATION OF HEALTHY CONTROLS | Active comparator | Not described Receives: Biological: Anti-pandemic H1N1 influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (adverse effects) and efficacy (serconversion rate) after 21 days from the vaccination
Measured: Before and after 21 days from vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2010 (estimated)
- Study startApr 2010
- Primary completionJul 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01151644
- Sponsor's protocol ID
- CEDMAC-H1N1
- Status last verified
- Apr 2010
- First submitted
- 25 Jun 2010
- Last updated
- 28 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Sampaio-Barros PD, Andrade DCO, Seguro LCP, Pasoto SG, Viana VST, Ribeiro ACM, Aikawa NE, Timenetsky MDCS, Precioso AR, Silva CA, Bonfa E. Pandemic non-adjuvanted influenza A H1N1 vaccine in a cohort of patients with systemic sclerosis. Rheumatology (Oxford). 2018 Oct 1;57(10):1721-1725. doi: 10.1093/rheumatology/kex330.
PubMed 28968874de Medeiros DM, Silva CA, Bueno C, Ribeiro AC, Viana Vdos S, Carvalho JF, Bonfa E. Pandemic influenza immunization in primary antiphospholipid syndrome (PAPS): a trigger to thrombosis and autoantibody production? Lupus. 2014 Nov;23(13):1412-6. doi: 10.1177/0961203314540351. Epub 2014 Jun 24.
PubMed 24961747Campos LM, Silva CA, Aikawa NE, Jesus AA, Moraes JC, Miraglia J, Ishida MA, Bueno C, Pereira RM, Bonfa E. High disease activity: an independent factor for reduced immunogenicity of the pandemic influenza a vaccine in patients with juvenile systemic lupus erythematosus. Arthritis Care Res (Hoboken). 2013 Jul;65(7):1121-7. doi: 10.1002/acr.21948.
PubMed 23818263Miossi R, Fuller R, Moraes JC, Ribeiro AC, Saad CG, Aikawa NE, Miraglia JL, Ishida MA, Bonfa E, Caleiro MT. Immunogenicity of influenza H1N1 vaccination in mixed connective tissue disease: effect of disease and therapy. Clinics (Sao Paulo). 2013;68(2):129-34. doi: 10.6061/clinics/2013(02)oa02.
PubMed 23525305Shinjo SK, de Moraes JC, Levy-Neto M, Aikawa NE, de Medeiros Ribeiro AC, Schahin Saad CG, Precioso A, Silva CA, Bonfa E. Pandemic unadjuvanted influenza A (H1N1) vaccine in dermatomyositis and polymyositis: immunogenicity independent of therapy and no harmful effect in disease. Vaccine. 2012 Dec 17;31(1):202-6. doi: 10.1016/j.vaccine.2012.10.063. Epub 2012 Oct 30.
PubMed 23123020Aikawa NE, Campos LM, Goldenstein-Schainberg C, Saad CG, Ribeiro AC, Bueno C, Precioso AR, Timenetsky Mdo C, Silva CA, Bonfa E. Effective seroconversion and safety following the pandemic influenza vaccination (anti-H1N1) in patients with juvenile idiopathic arthritis. Scand J Rheumatol. 2013;42(1):34-40. doi: 10.3109/03009742.2012.709272. Epub 2012 Sep 20.
PubMed 22992045Ribeiro AC, Laurindo IM, Guedes LK, Saad CG, Moraes JC, Silva CA, Bonfa E. Abatacept and reduced immune response to pandemic 2009 influenza A/H1N1 vaccination in patients with rheumatoid arthritis. Arthritis Care Res (Hoboken). 2013 Mar;65(3):476-80. doi: 10.1002/acr.21838.
PubMed 22949223Guissa VR, Pereira RM, Sallum AM, Aikawa NE, Campos LM, Silva CA, Bonfa E. Influenza A H1N1/2009 vaccine in juvenile dermatomyositis: reduced immunogenicity in patients under immunosuppressive therapy. Clin Exp Rheumatol. 2012 Jul-Aug;30(4):583-8. Epub 2012 Aug 29.
PubMed 22931582Franca IL, Ribeiro AC, Aikawa NE, Saad CG, Moraes JC, Goldstein-Schainberg C, Laurindo IM, Precioso AR, Ishida MA, Sartori AM, Silva CA, Bonfa E. TNF blockers show distinct patterns of immune response to the pandemic influenza A H1N1 vaccine in inflammatory arthritis patients. Rheumatology (Oxford). 2012 Nov;51(11):2091-8. doi: 10.1093/rheumatology/kes202. Epub 2012 Aug 20.
PubMed 22908326Borba EF, Saad CG, Pasoto SG, Calich AL, Aikawa NE, Ribeiro AC, Moraes JC, Leon EP, Costa LP, Guedes LK, Silva CA, Goncalves CR, Fuller R, Oliveira SA, Ishida MA, Precioso AR, Bonfa E. Influenza A/H1N1 vaccination of patients with SLE: can antimalarial drugs restore diminished response under immunosuppressive therapy? Rheumatology (Oxford). 2012 Jun;51(6):1061-9. doi: 10.1093/rheumatology/ker427. Epub 2012 Jan 31.
PubMed 22298793Aikawa NE, Campos LM, Silva CA, Carvalho JF, Saad CG, Trudes G, Duarte A, Miraglia JL, Timenetsky Mdo C, Viana VS, Franca IL, Bonfa E, Pereira RM. Glucocorticoid: major factor for reduced immunogenicity of 2009 influenza A (H1N1) vaccine in patients with juvenile autoimmune rheumatic disease. J Rheumatol. 2012 Jan;39(1):167-73. doi: 10.3899/jrheum.110721. Epub 2011 Nov 15.
PubMed 22089462Ribeiro AC, Guedes LK, Moraes JC, Saad CG, Aikawa NE, Calich AL, Franca IL, Carvalho JF, Sampaio-Barros PD, Goncalves CR, Borba EF, Timenetsky Mdo C, Precioso AR, Duarte A, Bonfa E, Laurindo IM. Reduced seroprotection after pandemic H1N1 influenza adjuvant-free vaccination in patients with rheumatoid arthritis: implications for clinical practice. Ann Rheum Dis. 2011 Dec;70(12):2144-7. doi: 10.1136/ard.2011.152983. Epub 2011 Aug 22.
PubMed 21859696Saad CG, Borba EF, Aikawa NE, Silva CA, Pereira RM, Calich AL, Moraes JC, Ribeiro AC, Viana VS, Pasoto SG, Carvalho JF, Franca IL, Guedes LK, Shinjo SK, Sampaio-Barros PD, Caleiro MT, Goncalves CR, Fuller R, Levy-Neto M, Timenetsky Mdo C, Precioso AR, Bonfa E. Immunogenicity and safety of the 2009 non-adjuvanted influenza A/H1N1 vaccine in a large cohort of autoimmune rheumatic diseases. Ann Rheum Dis. 2011 Jun;70(6):1068-73. doi: 10.1136/ard.2011.150250.
PubMed 21540203
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Anti-Pandemic H1N1 Vaccination in Rheumatic Diseases
- ClinicalTrials.gov ID
- NCT01151644
- Acronym / sponsor ID
- CEDMAC-H1N1
- Conditions
- Rheumatoid Arthritis, Spondyloarthritis, Systemic Lupus Erythematosus (SLE), Dermatomyositis (DM), DMixed Connective Tissue Disease, Systemic Vasculitis
- Keywords
- H1N1 VACCINE, INFLUENZA, RHEUMATIC DISEASES, ANTI-H1N1 IMMUNIZATION
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Apr 2010
- Primary completion
- Jul 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 28 Jun 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 prognosis of rheumatic diseases has improved considerably with development of therapy. However, infections are considered the most important cause of morbidity and mortality in this group of patients. One of the ways to prevent such complications is vaccination. In 2009, a new pandemic strain of influenza virus (A/H1N1/2009) has emerged raising major concerns for public health. Patients under immunosuppressive therapy have indication for immunization against influenza virus H1N1. There are, however, concerns about possibility of reactivation of autoimmune diseases, determine adverse events and insufficient immunogenicity in these patients. The lack of studies evaluating the efficacy and safety of the vaccine against influenza A(H1N1)/2009 in these rheumatic patients led to the development of this research. The objectives of this study are to evaluate the humoral response and safety of the vaccine virus A(H1N1)/2009 in immunosuppressed patients with rheumatic diseases compared to healthy controls. We have recruited 400 patients with rheumatoid arthritis, 350 with spondyloarthritis, 1000 with systemic lupus erythematosus (SLE), 150 with dermatomyositis (DM), 100 with mixed connective tissue disease, 150 with systemic vasculitis, 250 with systemic sclerosis (SSc) , 100 with Sjögren's syndrome, 100 with antiphospholipid syndrome, 100 patients with juvenile idiopathic arthritis, 80 with juvenile SLE, and 80 with juvenile DM, followed at our Rheumatology Outpatient Division and Unit Pediatric Rheumatology Children's Institute, HC-FMUSP. The control group was recruited were 200 healthy employees of ICHC-FMUSP. Informed consent was obtained from all participants and the study was approved by the Local Ethical Committee. All subjects were vaccinated against influenza virus A/(H1N1)/2009 (vaccine approved and supplied by Instituto Butantan-São Paulo). Blood samples was collected to measure levels of antibodies inhibiting hemagglutination by influenza virus A (H1N1)/2009 immediately prior to vaccination and 21 to 28 days after vaccination., Participants fulfilled a questionnaire on the immediate side effects of the vaccine. All patients with rheumatoid arthritis, spondyloarthritis, SLE, DM, systemic vasculitis, juvenile idiopathic arthritis, juvenile SLE, and DM were assessed before and 21 days after vaccination for clinical, laboratory parameters of disease activity as well as treatment. Continuous variables will be compared by t-test to evaluate differences between patients with rheumatic diseases versus healthy controls. Differences between categorical variables will be evaluated using the chi-square or Fisher exact test. Statistical significance was set at p<0.05.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VACCINATION OF PATIENTS | Active comparator | Biological: Anti-pandemic H1N1 influenza vaccine |
| VACCINATION OF HEALTHY CONTROLS | Active comparator | Biological: Anti-pandemic H1N1 influenza vaccine |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Rheumatic diseases according to international criteria of each disorder
Key exclusion criteria (4 listed)
- Previous and confirmed infection by virus A(H1N1)/2009
- History of anaphylatic reaction to egg components
- Acute fever
- Guillain-Barré syndrome, heart failure (classes III or IV), demyelinating disease
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 |
|---|---|---|
| Anti-pandemic H1N1 influenza vaccineinactivated, NON-adjuvanted pandemic H1N1 influenza vaccine (A/California/7/2009) | Biological | VACCINATION OF HEALTHY CONTROLS, VACCINATION OF PATIENTS |
Primary outcome
Safety (adverse effects) and efficacy (serconversion rate) after 21 days from the vaccination
Time frame: Before and after 21 days from vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2010.
- Derived from this study: PubMed 28968874Sampaio-Barros PD, Andrade DCO, Seguro LCP, Pasoto SG, Viana VST, Ribeiro ACM, Aikawa NE, Timenetsky MDCS, Precioso AR, Silva CA, Bonfa E. Pandemic non-adjuvanted influenza A H1N1 vaccine in a cohort of patients with systemic sclerosis. Rheumatology (Oxford). 2018 Oct 1;57(10):1721-1725. doi: 10.1093/rheumatology/kex330.
- Derived from this study: PubMed 24961747de Medeiros DM, Silva CA, Bueno C, Ribeiro AC, Viana Vdos S, Carvalho JF, Bonfa E. Pandemic influenza immunization in primary antiphospholipid syndrome (PAPS): a trigger to thrombosis and autoantibody production? Lupus. 2014 Nov;23(13):1412-6. doi: 10.1177/0961203314540351. Epub 2014 Jun 24.
- Derived from this study: PubMed 23818263Campos LM, Silva CA, Aikawa NE, Jesus AA, Moraes JC, Miraglia J, Ishida MA, Bueno C, Pereira RM, Bonfa E. High disease activity: an independent factor for reduced immunogenicity of the pandemic influenza a vaccine in patients with juvenile systemic lupus erythematosus. Arthritis Care Res (Hoboken). 2013 Jul;65(7):1121-7. doi: 10.1002/acr.21948.
- Derived from this study: PubMed 23525305Miossi R, Fuller R, Moraes JC, Ribeiro AC, Saad CG, Aikawa NE, Miraglia JL, Ishida MA, Bonfa E, Caleiro MT. Immunogenicity of influenza H1N1 vaccination in mixed connective tissue disease: effect of disease and therapy. Clinics (Sao Paulo). 2013;68(2):129-34. doi: 10.6061/clinics/2013(02)oa02.
- Derived from this study: PubMed 23123020Shinjo SK, de Moraes JC, Levy-Neto M, Aikawa NE, de Medeiros Ribeiro AC, Schahin Saad CG, Precioso A, Silva CA, Bonfa E. Pandemic unadjuvanted influenza A (H1N1) vaccine in dermatomyositis and polymyositis: immunogenicity independent of therapy and no harmful effect in disease. Vaccine. 2012 Dec 17;31(1):202-6. doi: 10.1016/j.vaccine.2012.10.063. Epub 2012 Oct 30.
- Derived from this study: PubMed 22992045Aikawa NE, Campos LM, Goldenstein-Schainberg C, Saad CG, Ribeiro AC, Bueno C, Precioso AR, Timenetsky Mdo C, Silva CA, Bonfa E. Effective seroconversion and safety following the pandemic influenza vaccination (anti-H1N1) in patients with juvenile idiopathic arthritis. Scand J Rheumatol. 2013;42(1):34-40. doi: 10.3109/03009742.2012.709272. Epub 2012 Sep 20.
- Derived from this study: PubMed 22949223Ribeiro AC, Laurindo IM, Guedes LK, Saad CG, Moraes JC, Silva CA, Bonfa E. Abatacept and reduced immune response to pandemic 2009 influenza A/H1N1 vaccination in patients with rheumatoid arthritis. Arthritis Care Res (Hoboken). 2013 Mar;65(3):476-80. doi: 10.1002/acr.21838.
- Derived from this study: PubMed 22931582Guissa VR, Pereira RM, Sallum AM, Aikawa NE, Campos LM, Silva CA, Bonfa E. Influenza A H1N1/2009 vaccine in juvenile dermatomyositis: reduced immunogenicity in patients under immunosuppressive therapy. Clin Exp Rheumatol. 2012 Jul-Aug;30(4):583-8. Epub 2012 Aug 29.
- Derived from this study: PubMed 22908326Franca IL, Ribeiro AC, Aikawa NE, Saad CG, Moraes JC, Goldstein-Schainberg C, Laurindo IM, Precioso AR, Ishida MA, Sartori AM, Silva CA, Bonfa E. TNF blockers show distinct patterns of immune response to the pandemic influenza A H1N1 vaccine in inflammatory arthritis patients. Rheumatology (Oxford). 2012 Nov;51(11):2091-8. doi: 10.1093/rheumatology/kes202. Epub 2012 Aug 20.
- Derived from this study: PubMed 22298793Borba EF, Saad CG, Pasoto SG, Calich AL, Aikawa NE, Ribeiro AC, Moraes JC, Leon EP, Costa LP, Guedes LK, Silva CA, Goncalves CR, Fuller R, Oliveira SA, Ishida MA, Precioso AR, Bonfa E. Influenza A/H1N1 vaccination of patients with SLE: can antimalarial drugs restore diminished response under immunosuppressive therapy? Rheumatology (Oxford). 2012 Jun;51(6):1061-9. doi: 10.1093/rheumatology/ker427. Epub 2012 Jan 31.
- Derived from this study: PubMed 22089462Aikawa NE, Campos LM, Silva CA, Carvalho JF, Saad CG, Trudes G, Duarte A, Miraglia JL, Timenetsky Mdo C, Viana VS, Franca IL, Bonfa E, Pereira RM. Glucocorticoid: major factor for reduced immunogenicity of 2009 influenza A (H1N1) vaccine in patients with juvenile autoimmune rheumatic disease. J Rheumatol. 2012 Jan;39(1):167-73. doi: 10.3899/jrheum.110721. Epub 2011 Nov 15.
- Derived from this study: PubMed 21859696Ribeiro AC, Guedes LK, Moraes JC, Saad CG, Aikawa NE, Calich AL, Franca IL, Carvalho JF, Sampaio-Barros PD, Goncalves CR, Borba EF, Timenetsky Mdo C, Precioso AR, Duarte A, Bonfa E, Laurindo IM. Reduced seroprotection after pandemic H1N1 influenza adjuvant-free vaccination in patients with rheumatoid arthritis: implications for clinical practice. Ann Rheum Dis. 2011 Dec;70(12):2144-7. doi: 10.1136/ard.2011.152983. Epub 2011 Aug 22.
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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 4 study testing Anti-pandemic H1N1 influenza vaccine in people with Rheumatoid Arthritis and Spondyloarthritis, run by University of Sao Paulo at 1 site in Brazil.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 28 Jun 2010. 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 Brazil. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
Safety (adverse effects) and efficacy (serconversion rate) after 21 days from the vaccination (time frame: Before and after 21 days from 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 NCT01151644, which also lists 13 linked publications.
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 28 Jun 2010.