InfluenzaPhase 4NCT02686398
Immunogenicity of a Trivalent Influenza Vaccine in Chronic Kidney Disease Patients Undergoing Hemodialysis
A Phase 4 study testing Fluad and Agrippal in people with Influenza and End Stage Renal Failure, run by Korea University Guro Hospital.
Trial summary
During the 2013-2014 influenza season, CKD patients undergoing HD participated in the study. The patients were randomized into two groups (MF59-adjuvanted vaccine group or non-adjuvanted vaccine group) and were immunized with the respective vaccine. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Influenza, End Stage Renal Failure, Chronic Kidney Disease
- What is being tested?
- Fluad and Agrippal
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Nov 2014
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic kidney disease patients undergoing hemodialysis
- Who have given written informed consent at the time of enrollment
Who cannot join
- Recipients of influenza vaccine of 2013-2014 season before the study
- History of egg allergy
About this study
Official title: Immunogenicity of a Trivalent Influenza Vaccine in Patients With Chronic Kidney Disease Undergoing Hemodialysis: MF59-adjuvanted Versus Non-adjuvanted Vaccines
During the 2013-2014 influenza season, CKD patients undergoing HD participated in the study. The patients were randomized into two groups (MF59-adjuvanted vaccine group or non-adjuvanted vaccine group) and were immunized with the respective vaccine. Sera were collected prior to vaccination and at 1and 6 months post vaccination. Levels of hemagglutination inhibition (HI) antibodies were measured.
- Conditions
- Influenza, End Stage Renal Failure, Chronic Kidney Disease
- Being tested
- Fluad, Agrippal
- Keywords
- Influenza Vaccines, MF59 oil emulsion, End Stage Renal Failure on Dialysis
- Medical subject headings
- Influenza, Human, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluadBiological
AgrippalBiological
| Study group | Role | What they receive |
|---|---|---|
| Fluad | Active comparator | 88 CKD patients were vaccinated with Fluad. Receives: Biological: Fluad |
| Agrippal | Active comparator | 86 CKD patients were vaccinated with Agrippal. Receives: Biological: Agrippal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroprotection rate (A/H1N1, A/H3N2, B)
the proportion of participants with a HI titer level of ≥1:40
Measured: 1 month after vaccination
Seroconversion rate (A/H1N1, A/H3N2, B)
the percentage of subjects with either a pre-vaccination HI titer ≥1:10 and a ≥4-fold increase in 1 month after vaccination HI antibody titer from pre-vaccination or pre-vaccination HI titer <1:10 and a 1 month after vaccination HI titer of ≥1:40
Measured: Change of titer from pre-vaccination to 1 month after vaccination
GMT fold change (A/H1N1, A/H3N2, B)
GMT ratio of the 1 month after vaccination titer to pre-vaccination titer
Measured: Change of GMT from pre-vaccination to 1 month after vaccination
Secondary outcomes (3)
Seroprotection rate (A/H1N1, A/H3N2, B)
the proportion of participants with a HI titer level of ≥1:40
Measured: 6 months after vaccination
Seroconversion rate (A/H1N1, A/H3N2, B)
the percentage of subjects with either a pre-vaccination HI titer ≥1:10 and a ≥4-fold increase in 6 months after vaccination HI antibody titer from pre-vaccination or pre-vaccination HI titer <1:10 and a 6 months after vaccination HI titer of ≥1:40
Measured: Change of titer from pre-vaccination to 6 months after vaccination
GMT fold change (A/H1N1, A/H3N2, B)
GMT ratio of the 6 months after vaccination titer to pre-vaccination titer
Measured: Change of GMT from pre-vaccination to 6 months after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2016 (estimated)
- Study startOct 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Guro Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee Jin Cheong, Korea University Guro Hospital
- Investigators
- Hee Jin Cheong, MD, PhD, Principal investigator, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02686398
- Sponsor's protocol ID
- KUGH13170
- Status last verified
- Feb 2016
- First submitted
- 25 Jan 2016
- Last updated
- 19 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity of a Trivalent Influenza Vaccine in Patients With Chronic Kidney Disease Undergoing Hemodialysis: MF59-adjuvanted Versus Non-adjuvanted Vaccines
- ClinicalTrials.gov ID
- NCT02686398
- Acronym / sponsor ID
- KUGH13170
- Conditions
- Influenza, End Stage Renal Failure, Chronic Kidney Disease
- Keywords
- Influenza Vaccines, MF59 oil emulsion, End Stage Renal Failure on Dialysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 19 Feb 2016 (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.
During the 2013-2014 influenza season, CKD patients undergoing HD participated in the study. The patients were randomized into two groups (MF59-adjuvanted vaccine group or non-adjuvanted vaccine group) and were immunized with the respective vaccine. Sera were collected prior to vaccination and at 1and 6 months post vaccination. Levels of hemagglutination inhibition (HI) antibodies were measured.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluad | Active comparator | Biological: Fluad88 CKD patients were vaccinated with Fluad. |
| Agrippal | Active comparator | Biological: Agrippal86 CKD patients were vaccinated with Agrippal. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chronic kidney disease patients undergoing hemodialysis
- Who have given written informed consent at the time of enrollment
Key exclusion criteria (2 listed)
- Recipients of influenza vaccine of 2013-2014 season before the study
- History of egg allergy
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 | Biological | Fluad |
| Agrippal | Biological | Agrippal |
Primary outcome
Seroprotection rate (A/H1N1, A/H3N2, B)
Time frame: 1 month after vaccination
the proportion of participants with a HI titer level of ≥1:40
Seroconversion rate (A/H1N1, A/H3N2, B)
Time frame: Change of titer from pre-vaccination to 1 month after vaccination
the percentage of subjects with either a pre-vaccination HI titer ≥1:10 and a ≥4-fold increase in 1 month after vaccination HI antibody titer from pre-vaccination or pre-vaccination HI titer <1:10 and a 1 month after vaccination HI titer of ≥1:40
GMT fold change (A/H1N1, A/H3N2, B)
Time frame: Change of GMT from pre-vaccination to 1 month after vaccination
GMT ratio of the 1 month after vaccination titer to pre-vaccination titer
3 secondary outcomes
Seroprotection rate (A/H1N1, A/H3N2, B)
Time frame: 6 months after vaccination
Seroconversion rate (A/H1N1, A/H3N2, B)
Time frame: Change of titer from pre-vaccination to 6 months after vaccination
GMT fold change (A/H1N1, A/H3N2, B)
Time frame: Change of GMT from pre-vaccination to 6 months after vaccination
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 19 Feb 2016.
Related trials for Influenza
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza
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.
Hee Jin Cheong, MD, PhD principal investigator
Korea University Guro Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluad and Agrippal in people with Influenza and End Stage Renal Failure, run by Korea University Guro Hospital.
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 2 inclusion and 2 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 19 Feb 2016. 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 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?
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?
Seroprotection rate (A/H1N1, A/H3N2, B) (time frame: 1 month after vaccination). The study lists 3 primary outcomes in all. 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 19 Feb 2016.