ESRDPhase 4EnhanceNCT05070494
Efficacy of Different Doses of Influenza Vaccine in Chronic Hemodialysis Patients
A Phase 4 study testing Egg-derived standard dose trivalent influenza vaccine (surface antigen, inactivated) in people with ESRD and Influenza Vaccine, run by Mahidol University at 1 site in Thailand.
Trial summary
This study was a randomized controlled trial to investigate the immune response of influenza vaccines when doses were increased. and a second vaccination together with an increase in the amount of vaccine in patients with chronic kidney disease receiving hemodialysis Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- ESRD, Influenza Vaccine, Seroprotection
- What is being tested?
- Egg-derived standard dose trivalent influenza vaccine (surface antigen, inactivated)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteThailand
- Study dates
- 1 Mar 2021to 1 Dec 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Received kidney replacement therapy with dialysis for more than 1 month.
- Hemodialysis at least 3 times a week
- (Kt/v) greater than 1.2
- Never received an organ transplant.
- Life expectancy of more than 1 year
- Research participants or representatives are welcome to join the project by signing.
Who cannot join
- History of any vaccinations in the 4 weeks prior to the study.
- History of receiving influenza vaccine 6 months before entering this study.
- History of allergy to flu vaccine or allergic to egg white
- Fever or headache, muscle pain (influenza-like illness) 3 days before vaccination
- Thrombocytopenia
- On immunosuppressive drug (Prednisolone 15 mg daily or equivalent for two weeks in a row in the previous 3 months) or immunocompromised patient
- Patient or family history of having had Guillain-Barre disease. (Guillain-Barre syndrome)
- The research participant or his representative refuses or requests to withdraw.
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Angsana Phuphuakrat
Ratchathewi, ฺBangkok, 10400
Angsana Phuphuakrat, MD, PhD, 6622011581, angsana.phu@mahidol.ac.th
About this study
Official title: Efficacy of Different Doses of Influenza Vaccine in Chronic Hemodialysis Patients: Randomized Controlled Trial (Enhance Study)
This study was a randomized controlled trial to investigate the immune response of influenza vaccines when doses were increased. and a second vaccination together with an increase in the amount of vaccine in patients with chronic kidney disease receiving hemodialysis
Read the detailed description
- Patients with chronic kidney disease undergoing dialysis will be examined by an internist.
- Collect the necessary basic information of patients who agree to participate in the treatment.
- Patients will be randomized to be divided into 3 groups: those who will receive an standard dose of influenza vaccine, those who will receive double standard dose of influenza vaccine (double-dose) and those who will receive double standard dose of influenza vaccine and Six months after the first dose of vaccination (double-booster-dose), 50 people per group.
- Non-dialysis volunteers will be invited to participate in the research. to be a control group of 25 people
- Patients with chronic kidney disease and volunteers will receive basic laboratory blood tests.
- Patients with chronic kidney disease and volunteers will be vaccinated against influenza. shoulder muscle area according to random groups The details of using Influvac vaccine of that year are produced by Abbott.
- Patients with chronic kidney disease and volunteers are asked about the potential side effects of vaccination. according to research guidelines both systemic side effects and injection site Each time receiving hemodialysis 3 times a week for 2 weeks after vaccination
- Patients with chronic kidney disease and volunteers were asked about the onset of symptoms of respiratory infection throughout the 12-month study period after vaccination.
- Patients will receive a blood test to check their immune response to influenza vaccine. (Hemagglutination inhibition assays and activation and/or exhaustion T cell markers, T cell subpopulation by flow cytometry) at 1, 6, 7 and 12 months after influenza vaccination.
- Conditions
- ESRD, Influenza Vaccine, Seroprotection
- Being tested
- Egg-derived standard dose trivalent influenza vaccine (surface antigen, inactivated)
- Keywords
- ESRD, Influenza vaccine, double dose Influenza vaccine, double dose booster Influenza vaccine, Immune response
- Medical subject headings
- Kidney Failure, Chronic, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Egg-derived standard dose trivalent influenza vaccine (surface antigen, inactivated)Biological
study of immunologic response to different dose and duration of Egg-derived standard dose trivalent influenza vaccine (surface antigen, inactivated)
| Study group | Role | What they receive |
|---|---|---|
| ้healthy subject with standard dose trivalent influenza vaccine | Other | ้healthy volunteer that received Egg-derived standard dose trivalent influenza vaccine (surface antigen, inactivated) ( 0.5 ml : 15 mcg/strain) Receives: Biological: Egg-derived standard dose trivalent influenza vaccine (surface antigen, inactivated) |
| ESRD patient with standard dose trivalent influenza vaccine | Active comparator | ESRD patient that received Egg-derived standard dose trivalent influenza vaccine (surface antigen, inactivated) ( 0.5 ml : 15 mcg/strain) Receives: Biological: Egg-derived standard dose trivalent influenza vaccine (surface antigen, inactivated) |
| ESRD patient with double dose trivalent influenza vaccine | Experimental | ESRD patient that received Egg-derived double dose trivalent influenza vaccine (surface antigen, inactivated) total 1 ml ( 1 ml /(30 mcg/strain) Receives: Biological: Egg-derived standard dose trivalent influenza vaccine (surface antigen, inactivated) |
| ESRD patient with double dose - booster trivalent influenza vaccine | Experimental | ESRD patient that received Egg-derived double dose trivalent influenza vaccine (surface antigen, inactivated) ( 1 ml /(30 mcg/strain) and booster with Egg-derived double dose trivalent influenza vaccine (surface antigen, inactivated) ( 1 ml /(30 mcg/strain) at next 6 months after first dose Receives: Biological: Egg-derived standard dose trivalent influenza vaccine (surface antigen, inactivated) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare proportion of seroprotection of different doses of influenza vaccine in hemodialysis patients at month 12
Patients will receive a blood test to check their immune response to influenza vaccine. (Hemagglutination inhibition assays and activation and/or exhaustion T cell markers, T cell subpopulation by flow cytometry) at month 12 after influenza vaccination.
Measured: 12 months
Secondary outcomes (1)
To compare the prevention of influenza virus infection in different doses of influenza vaccination.
to compare incidence rate of influenza infection in different doses of influenza
Measured: 12 months of data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2021
- Study start1 Mar 2021
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for ESRDStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- Bhumirajanagarindra Kidney Institute, Thailand, Ministry of Health, Thailand
- Responsible party
- Principal investigator, Angsana Phuphuakrat, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05070494
- Sponsor's protocol ID
- MURA2019/1116
- Acronym
- Enhance
- Status last verified
- Nov 2021
- First submitted
- 4 Sep 2021
- Last updated
- 3 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chou CY, Wang SM, Liang CC, Chang CT, Liu JH, Wang IK, Hsiao LC, Muo CH, Huang CC, Wang RY. Risk of pneumonia among patients with chronic kidney disease in outpatient and inpatient settings: a nationwide population-based study. Medicine (Baltimore). 2014 Dec;93(27):e174. doi: 10.1097/MD.0000000000000174.
PubMed 25501062Collins AJ, Foley RN, Gilbertson DT, Chen SC. The state of chronic kidney disease, ESRD, and morbidity and mortality in the first year of dialysis. Clin J Am Soc Nephrol. 2009 Dec;4 Suppl 1:S5-11. doi: 10.2215/CJN.05980809.
PubMed 19996006Viasus D, Garcia-Vidal C, Cruzado JM, Adamuz J, Verdaguer R, Manresa F, Dorca J, Gudiol F, Carratala J. Epidemiology, clinical features and outcomes of pneumonia in patients with chronic kidney disease. Nephrol Dial Transplant. 2011 Sep;26(9):2899-906. doi: 10.1093/ndt/gfq798. Epub 2011 Jan 27.
PubMed 21273232Sarnak MJ, Jaber BL. Pulmonary infectious mortality among patients with end-stage renal disease. Chest. 2001 Dec;120(6):1883-7. doi: 10.1378/chest.120.6.1883.
PubMed 11742917Cohen G, Horl WH. Immune dysfunction in uremia—an update. Toxins (Basel). 2012 Oct 24;4(11):962-90. doi: 10.3390/toxins4110962.
PubMed 23202302Girndt M, Sester M, Sester U, Kaul H, Kohler H. Molecular aspects of T- and B-cell function in uremia. Kidney Int Suppl. 2001 Feb;78:S206-11. doi: 10.1046/j.1523-1755.2001.59780206.x.
PubMed 11169012Anding K, Gross P, Rost JM, Allgaier D, Jacobs E. The influence of uraemia and haemodialysis on neutrophil phagocytosis and antimicrobial killing. Nephrol Dial Transplant. 2003 Oct;18(10):2067-73. doi: 10.1093/ndt/gfg330.
PubMed 13679482Lim WH, Kireta S, Leedham E, Russ GR, Coates PT. Uremia impairs monocyte and monocyte-derived dendritic cell function in hemodialysis patients. Kidney Int. 2007 Nov;72(9):1138-48. doi: 10.1038/sj.ki.5002425. Epub 2007 Aug 29.
PubMed 17728708Sester U, Sester M, Hauk M, Kaul H, Kohler H, Girndt M. T-cell activation follows Th1 rather than Th2 pattern in haemodialysis patients. Nephrol Dial Transplant. 2000 Aug;15(8):1217-23. doi: 10.1093/ndt/15.8.1217.
PubMed 10910448Fernandez-Fresnedo G, Ramos MA, Gonzalez-Pardo MC, de Francisco AL, Lopez-Hoyos M, Arias M. B lymphopenia in uremia is related to an accelerated in vitro apoptosis and dysregulation of Bcl-2. Nephrol Dial Transplant. 2000 Apr;15(4):502-10. doi: 10.1093/ndt/15.4.502.
PubMed 10727545Meier P, Golshayan D, Blanc E, Pascual M, Burnier M. Oxidized LDL modulates apoptosis of regulatory T cells in patients with ESRD. J Am Soc Nephrol. 2009 Jun;20(6):1368-84. doi: 10.1681/ASN.2008070734. Epub 2009 Apr 30.
PubMed 19406979Wang IK, Lin CL, Lin PC, Liang CC, Liu YL, Chang CT, Yen TH, Morisky DE, Huang CC, Sung FC. Effectiveness of influenza vaccination in patients with end-stage renal disease receiving hemodialysis: a population-based study. PLoS One. 2013;8(3):e58317. doi: 10.1371/journal.pone.0058317. Epub 2013 Mar 13.
PubMed 23516462McGrath LJ, Kshirsagar AV, Cole SR, Wang L, Weber DJ, Sturmer T, Brookhart MA. Influenza vaccine effectiveness in patients on hemodialysis: an analysis of a natural experiment. Arch Intern Med. 2012 Apr 9;172(7):548-54. doi: 10.1001/archinternmed.2011.2238.
PubMed 22493462Gilbertson DT, Unruh M, McBean AM, Kausz AT, Snyder JJ, Collins AJ. Influenza vaccine delivery and effectiveness in end-stage renal disease. Kidney Int. 2003 Feb;63(2):738-43. doi: 10.1046/j.1523-1755.2003.00787.x.
PubMed 12631142Grohskopf LA, Sokolow LZ, Olsen SJ, Bresee JS, Broder KR, Karron RA. Prevention and Control of Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices, United States, 2015-16 Influenza Season. MMWR Morb Mortal Wkly Rep. 2015 Aug 7;64(30):818-25. doi: 10.15585/mmwr.mm6430a3.
PubMed 26247435
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Different Doses of Influenza Vaccine in Chronic Hemodialysis Patients: Randomized Controlled Trial (Enhance Study)
- ClinicalTrials.gov ID
- NCT05070494
- Acronym / sponsor ID
- Enhance / MURA2019/1116
- Conditions
- ESRD, Influenza Vaccine, Seroprotection
- Keywords
- ESRD, Influenza vaccine, double dose Influenza vaccine, double dose booster Influenza vaccine, Immune response
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- Bhumirajanagarindra Kidney Institute, Thailand, Ministry of Health, Thailand
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 7 Oct 2021 (actual)
- 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.
This study was a randomized controlled trial to investigate the immune response of influenza vaccines when doses were increased. and a second vaccination together with an increase in the amount of vaccine in patients with chronic kidney disease receiving hemodialysis
Detailed description
- Patients with chronic kidney disease undergoing dialysis will be examined by an internist.
- Collect the necessary basic information of patients who agree to participate in the treatment.
- Patients will be randomized to be divided into 3 groups: those who will receive an standard dose of influenza vaccine, those who will receive double standard dose of influenza vaccine (double-dose) and those who will receive double standard dose of influenza vaccine and Six months after the first dose of vaccination (double-booster-dose), 50 people per group.
- Non-dialysis volunteers will be invited to participate in the research. to be a control group of 25 people
- Patients with chronic kidney disease and volunteers will receive basic laboratory blood tests.
- Patients with chronic kidney disease and volunteers will be vaccinated against influenza. shoulder muscle area according to random groups The details of using Influvac vaccine of that year are produced by Abbott.
- Patients with chronic kidney disease and volunteers are asked about the potential side effects of vaccination. according to research guidelines both systemic side effects and injection site Each time receiving hemodialysis 3 times a week for 2 weeks after vaccination
- Patients with chronic kidney disease and volunteers were asked about the onset of symptoms of respiratory infection throughout the 12-month study period after vaccination.
- Patients will receive a blood test to check their immune response to influenza vaccine. (Hemagglutination inhibition assays and activation and/or exhaustion T cell markers, T cell subpopulation by flow cytometry) at 1, 6, 7 and 12 months after influenza vaccination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ้healthy subject with standard dose trivalent influenza vaccine | Other | Biological: Egg-derived standard dose trivalent influenza vaccine (surface antigen, inactivated)้healthy volunteer that received Egg-derived standard dose trivalent influenza vaccine (surface antigen, inactivated) ( 0.5 ml : 15 mcg/strain) |
| ESRD patient with standard dose trivalent influenza vaccine | Active comparator | Biological: Egg-derived standard dose trivalent influenza vaccine (surface antigen, inactivated)ESRD patient that received Egg-derived standard dose trivalent influenza vaccine (surface antigen, inactivated) ( 0.5 ml : 15 mcg/strain) |
| ESRD patient with double dose trivalent influenza vaccine | Experimental | Biological: Egg-derived standard dose trivalent influenza vaccine (surface antigen, inactivated)ESRD patient that received Egg-derived double dose trivalent influenza vaccine (surface antigen, inactivated) total 1 ml ( 1 ml /(30 mcg/strain) |
| ESRD patient with double dose - booster trivalent influenza vaccine | Experimental | Biological: Egg-derived standard dose trivalent influenza vaccine (surface antigen, inactivated)ESRD patient that received Egg-derived double dose trivalent influenza vaccine (surface antigen, inactivated) ( 1 ml /(30 mcg/strain) and booster with Egg-derived double dose trivalent influenza vaccine (surface antigen, inactivated) ( 1 ml /(30 mcg/strain) at next 6 months after first dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years
- Received kidney replacement therapy with dialysis for more than 1 month.
- Hemodialysis at least 3 times a week
- (Kt/v) greater than 1.2
- Never received an organ transplant.
Key exclusion criteria (8 listed)
- History of any vaccinations in the 4 weeks prior to the study.
- History of receiving influenza vaccine 6 months before entering this study.
- History of allergy to flu vaccine or allergic to egg white
- Fever or headache, muscle pain (influenza-like illness) 3 days before vaccination
- Thrombocytopenia
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 |
|---|---|---|
| Egg-derived standard dose trivalent influenza vaccine (surface antigen, inactivated)study of immunologic response to different dose and duration of Egg-derived standard dose trivalent influenza vaccine (surface antigen, inactivated) | Biological | ESRD patient with double dose - booster trivalent influenza vaccine, ESRD patient with double dose trivalent influenza vaccine, ESRD patient with standard dose trivalent influenza vaccine, ้healthy subject with standard dose trivalent influenza vaccine |
Primary outcome
To compare proportion of seroprotection of different doses of influenza vaccine in hemodialysis patients at month 12
Time frame: 12 months
Patients will receive a blood test to check their immune response to influenza vaccine. (Hemagglutination inhibition assays and activation and/or exhaustion T cell markers, T cell subpopulation by flow cytometry) at month 12 after influenza vaccination.
1 secondary outcome
To compare the prevention of influenza virus infection in different doses of influenza vaccination.
Time frame: 12 months of data collection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
- Background: PubMed 25501062Chou CY, Wang SM, Liang CC, Chang CT, Liu JH, Wang IK, Hsiao LC, Muo CH, Huang CC, Wang RY. Risk of pneumonia among patients with chronic kidney disease in outpatient and inpatient settings: a nationwide population-based study. Medicine (Baltimore). 2014 Dec;93(27):e174. doi: 10.1097/MD.0000000000000174.
- Background: PubMed 19996006Collins AJ, Foley RN, Gilbertson DT, Chen SC. The state of chronic kidney disease, ESRD, and morbidity and mortality in the first year of dialysis. Clin J Am Soc Nephrol. 2009 Dec;4 Suppl 1:S5-11. doi: 10.2215/CJN.05980809.
- Background: PubMed 21273232Viasus D, Garcia-Vidal C, Cruzado JM, Adamuz J, Verdaguer R, Manresa F, Dorca J, Gudiol F, Carratala J. Epidemiology, clinical features and outcomes of pneumonia in patients with chronic kidney disease. Nephrol Dial Transplant. 2011 Sep;26(9):2899-906. doi: 10.1093/ndt/gfq798. Epub 2011 Jan 27.
- Background: PubMed 11742917Sarnak MJ, Jaber BL. Pulmonary infectious mortality among patients with end-stage renal disease. Chest. 2001 Dec;120(6):1883-7. doi: 10.1378/chest.120.6.1883.
- Background: PubMed 23202302Cohen G, Horl WH. Immune dysfunction in uremia—an update. Toxins (Basel). 2012 Oct 24;4(11):962-90. doi: 10.3390/toxins4110962.
- Background: PubMed 11169012Girndt M, Sester M, Sester U, Kaul H, Kohler H. Molecular aspects of T- and B-cell function in uremia. Kidney Int Suppl. 2001 Feb;78:S206-11. doi: 10.1046/j.1523-1755.2001.59780206.x.
- Background: PubMed 13679482Anding K, Gross P, Rost JM, Allgaier D, Jacobs E. The influence of uraemia and haemodialysis on neutrophil phagocytosis and antimicrobial killing. Nephrol Dial Transplant. 2003 Oct;18(10):2067-73. doi: 10.1093/ndt/gfg330.
- Background: PubMed 17728708Lim WH, Kireta S, Leedham E, Russ GR, Coates PT. Uremia impairs monocyte and monocyte-derived dendritic cell function in hemodialysis patients. Kidney Int. 2007 Nov;72(9):1138-48. doi: 10.1038/sj.ki.5002425. Epub 2007 Aug 29.
- Background: PubMed 10910448Sester U, Sester M, Hauk M, Kaul H, Kohler H, Girndt M. T-cell activation follows Th1 rather than Th2 pattern in haemodialysis patients. Nephrol Dial Transplant. 2000 Aug;15(8):1217-23. doi: 10.1093/ndt/15.8.1217.
- Background: PubMed 10727545Fernandez-Fresnedo G, Ramos MA, Gonzalez-Pardo MC, de Francisco AL, Lopez-Hoyos M, Arias M. B lymphopenia in uremia is related to an accelerated in vitro apoptosis and dysregulation of Bcl-2. Nephrol Dial Transplant. 2000 Apr;15(4):502-10. doi: 10.1093/ndt/15.4.502.
- Background: PubMed 19406979Meier P, Golshayan D, Blanc E, Pascual M, Burnier M. Oxidized LDL modulates apoptosis of regulatory T cells in patients with ESRD. J Am Soc Nephrol. 2009 Jun;20(6):1368-84. doi: 10.1681/ASN.2008070734. Epub 2009 Apr 30.
- Background: PubMed 23516462Wang IK, Lin CL, Lin PC, Liang CC, Liu YL, Chang CT, Yen TH, Morisky DE, Huang CC, Sung FC. Effectiveness of influenza vaccination in patients with end-stage renal disease receiving hemodialysis: a population-based study. PLoS One. 2013;8(3):e58317. doi: 10.1371/journal.pone.0058317. Epub 2013 Mar 13.
- Related InfoLink provided by the sponsor.
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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.
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 Egg-derived standard dose trivalent influenza vaccine (surface antigen, inactivated) in people with ESRD and Influenza Vaccine, run by Mahidol University at 1 site in Thailand.
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 7 inclusion and 8 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 3 Nov 2021. 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 Thailand. 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?
Contact Angsana Phuphuakrat, MD, PhD (6622011581, angsana.phu@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare proportion of seroprotection of different doses of influenza vaccine in hemodialysis patients at month 12 (time frame: 12 months). 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 NCT05070494, which also lists 20 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 3 Nov 2021.