Prevention of InfluenzaPhase 4NCT03160118
Study of Biomarkers of Immune Activation Associated with Symptoms and Immune Responses After Influenza Vaccination in Adults
A Phase 4 study testing Seasonal,quadrivalent,influenza vaccine in people with Prevention of Influenza, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
This clinical fase IV study, using the administration of a single dose of a quadrivalent, inactivated, split influenza virus vaccine as biological intervention will mirror a study conducted at Imperial College, London, UK that will use a challenge with live virus as intervention. Read more about this study
- Who is it for?
- Ages 24 to 54 yearsHealthy volunteers can take part
- Conditions the study is for
- Prevention of Influenza
- What is being tested?
- Seasonal,quadrivalent,influenza vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 27 Mar 2017to 28 Jun 2017
- 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 24 to 54 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female subjects aged 24-54 years inclusive. (Healthy in the opinion of the investigator, based on medical history and clinical exam, with no active disease process that could interfere with the study endpoints)
- Has a body Mass Index ≥18 and ≤30
- Is able to read and understand the Informed Consent Form (ICF), and understand study procedures.
- The subject has signed the ICF.
- The subject is available for follow-up for the duration of the study.
- The subject agrees to abstain from donating blood during their participation in the study, or longer if necessary.
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- If the subject is a heterosexually active female, she is willing to use an effective method of contraception (e.g. oral contraceptive pill; intrauterine device; injectable or implanted contraceptive; physiological or anatomical sterility) from 30 days prior to study vaccination until the end of the study.
- Willing to undergo urine pregnancy tests prior to vaccination at screening.
- The subject has venous access sufficient to allow blood sampling as per the protocol.
Who cannot join
- Pregnant or lactating.
- Known hypersensitivity to any component of the study vaccine (α-RIX-Tetra®): the active components (vaccine antigens) or any of the excipients (disodium phosphate dodecahydrate, potassium dihydrogen phosphate, magnesium chloride hexahydrate, α-tocopheryl hydrogen succinate, polysorbate 80, octoxinol 10), eggs (chicken proteins, ovalbumin), gentamycin sulphate, formaldehyde, and sodium deoxycholate or those who have had a previous life-threatening reaction to previous influenza vaccinations.
- History of influenza infection in the past 5 years, defined here as severe respiratory infection with fever (> 38°C) and preventing normal daily activity during a minimum of 3 days.
- Vaccination with the 2016/2017 seasonal influenza vaccine and/or any other seasonal influenza vaccine within the preceding 5 influenza seasons (i.e. since season 2011/2012) before the first study visit.
- Presence of primary or acquired immunodeficiency states with a total lymphocyte count less than 1,200 per mm3 or presenting other evidence of lack of cellular immune competence e.g. leukaemias, lymphomas, blood dyscrasias, or patients receiving immunosuppressive therapy (including use of oral or parenteral corticosteroids in a dose ≥ 5 mg prednisone daily or equivalent within one month prior to visit 1or cytotoxic or immunosuppressive or immunomodulating drugs within 6 months prior to visit 1).
- Regular use of non-steroidal anti-inflammatory drugs (oral or parenteral route) within 6 months of Visit 1 considered by the study physician as likely to interfere with immune responses.
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- Current intake of excessive amounts of alcohol (≥ 14 units for women and ≥ 21 units for men) and not willing to adapt this use during the study period.
- Currently performing extreme physical activities (as evaluated by the investigator) and not willing to adapt this activity during the study period.
- Receipt of a vaccine within 30 days of visit 1, or requirement to receive another vaccine within the study period.
- Presence of an acute severe febrile illness at time of immunisation.
- History of alcohol, narcotic, benzodiazepine, rilatine, or other substance abuse or dependence within the 12 months preceding Visit 1.
- Smoking in the past 6 months OR > 5 pack-year lifetime history
- Receipt of blood products or immunoglobulins, or blood donation, within 3 months of study start.
- Any condition that, in the investigator's opinion, compromises the subject's ability to meet protocol requirements or to complete the study.
- Currently participating in another clinical study with an investigational or non-investigational drug or device, or has participated in a clinical trial within the 3 months preceding Visit 1.
- Unable to read and speak Dutch or English to a fluency level adequate for the full comprehension of procedures required in participation and consent.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
University Hospital - Center for Vaccinology
Ghent, East-Flanders, 9000
About this study
Official title: A Clinical Study of Biomarkers of Innate and Adaptive Immune Activation Associated with Symptoms and Immune Responses After Administration of a Single Dose of a Quadrivalent Inactivated Split Virus Influenza Vaccine to Healthy Young Adults.
This clinical fase IV study, using the administration of a single dose of a quadrivalent, inactivated, split influenza virus vaccine as biological intervention will mirror a study conducted at Imperial College, London, UK that will use a challenge with live virus as intervention. Comparison of the clinical observations and laboratory measurements generated in both studies will inform us about the similarities and differences in innate and adaptive immune responses elicited by both types of exposure to influenza virus antigen(s).
Read the detailed description
The study is a monocentric, open label study. All subjects will receive a single dose of alfa-Rix Tetra 2016-2017. The following will be measured - clinical events (recorded adverse events), physiological responses (heart rate, blood pressure, temperature, injection site), innate immune responses (cytokine levels and whole blood gene expression) and adaptive immune responses (serum antibody and antigen-specific cellular responses) at various time points after immunisation.
At each study visit, full physiological parameters (including body temperature, heart rate, blood pressure) will be obtained and the injection site will be examined for the presence of any redness or swelling that will be measured and recorded. Standardized diary cards will be used to collect solicited and unsolicited clinical event data. At each visit the diary cards will be examined and any relevant clinical event will be entered into the clinical event form. Participants will be asked to monitor oral temperature from day 0 until day 7 when they wake up and when going to bed. The results of these measurements will be reported in a diary card. Any skin reactions at the site of injection will be evaluated; largest diameter of redness and swelling will be measured with a ruler and data reported on the diary card. Samples of blood (PAXgene tubes, plasma, serum and PBMCs (peripheral blood mononuclear cells)) will be collected for analysis and processing using protocols already in place. Subjects will also have blood obtained for standard safety markers (haematology, biochemistry) as well as acute phase proteins.
The purpose of this protocol is to generate a set of data that will be analysed by integrated systems biology approach, for validation in subsequent clinical trials or in animal models. The dataset will broadly characterise:
- Physiological responses at various time points after immunisation by measuring:
- Local and systemic vaccine-related clinical events.
- Physiological assessments: heart rate, body temperature, blood pressure.
- Haematology (Complete Blood Count (CBC), Erythrocyte Sedimentation Rate (ESR) , phenotyping of White Blood Cells (WBC)), biochemistry parameters.
- Innate and adaptive immune responses including:
- Innate immune activation detected by global gene expression in whole blood
- Adaptive immunity determined by:
- Humoral immune response via serum anti-influenza HAI (Haemagglutination Inhibition) titre ii. Cellular immune response c. Immune activation detected by concentration of selected inflammatory soluble mediators in serum including: i. chemokines and cytokines ii. acute phase proteins
- Genetic testing of subjects when deemed necessary (genetic testing analysis may be SNIP (Single Nucleotide Polymorphism) analysis or full genome analysis).
- Correlations in changes in innate and adaptive immune activation with adverse events, haematology and biochemistry panels, genotype and physiological assessments
The study team will biobank all samples for the duration of the BIOVACSAFE programme so that different samples and different time points depending on the results generated can selectively be analysed, principally from the gene expression analysis of whole blood.
- Conditions
- Prevention of Influenza
- Being tested
- Seasonal,quadrivalent,influenza vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seasonal,quadrivalent,influenza vaccineDrug
Also called Alfa-Rix Tetra 2016-2017
1 dose to be administered on Day 0, the first visit
| Study group | Role | What they receive |
|---|---|---|
| Seasonal,quadrivalent,influenza vaccine | Other | 1 vaccine will be administered to all participants, namely Alfa-Rix Tetra 2016-2017 Receives: Drug: Seasonal,quadrivalent,influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of local vaccine-related clinical events.
Participants will report these events on a diary, measuring local events or scoring them from 0 (absent) to 3 (severe)
Measured: At all timepoints from vaccination up to 28 days after vaccination
Severity of local vaccine-related clinical events.
Participants will report these events on a diary, measuring local events or scoring them from 0 (absent) to 3 (severe)
Measured: At all timepoints from time of vaccination up to 28 days after vaccination
Frequency of systemic vaccine-related clinical events.
Participants will report these events on a diary, scoring the events from 0 (absent) to 3 (severe)
Measured: At selected timepoints from time of vaccination up to 28 days after vaccination
Severity of systemic vaccine-related clinical events.
Participants will report these events on a diary, scoring the events from 0 (absent) to 3 (severe)
Measured: At selected timepoints from time of vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in pulse.
Will be measured during the study visits
Measured: At selected timepoints from time of vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in body temperature
Will be measured during the study visits
Measured: At selected timepoints from time of vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in blood pressure
Will be measured during the study visits
Measured: At selected timepoints from time of vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in haematology (CBC, ESR, phenotyping of WBC) parameters
blood will be collected during the study visits
Measured: At selected timepoints from time of vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in biochemistry parameters
blood will be collected during the study visits
Measured: At selected timepoints from time of vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in global gene expression measured on whole blood samples
blood will be collected during the study visits
Measured: At selected timepoints from time of vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in serum HAI titre in serum samples
blood will be collected during the study visits
Measured: At selected timepoints from time of vaccination up to 28 days after vaccination
Change from pre-immunisation values of adaptive cellular immune response via enumeration of influenza-specific CD4+ T cells expressing activation markers and/or cytokines following in vitro stimulation and analysis by flow cytometry
blood will be collected during the study visits
Measured: At selected timepoints from time of vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in concentration of selected cytokines and acute phase proteins in serum samples
blood will be collected during the study visits
Measured: At selected timepoints from time of vaccination up to 28 days after vaccination
Change from pre-immunisation baseline values in PBMC cytokine secretion, proliferation or surface markers in response to in vitro stimulation with influenza antigens
blood will be collected during the study visits
Measured: At selected timepoints from time of vaccination up to 28 days 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 May 2017
- Study start27 Mar 2017
- Primary completion17 May 2017
- Study completion28 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention of InfluenzaStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent, Max Planck Institute for Infection Biology (MPIIB), Berlin, Germany, deCODE genetics, Iceland, VisMederi srl, Sienna, Italy
- Responsible party
- Sponsor
- Investigators
- Geert Leroux-Roels, Prof., PhD, Principal investigator, University Ghent / University Hospital Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03160118
- Sponsor's protocol ID
- BioVacSafe - QIV
- Status last verified
- Sep 2024
- First submitted
- 24 Mar 2017
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of Biomarkers of Innate and Adaptive Immune Activation Associated with Symptoms and Immune Responses After Administration of a Single Dose of a Quadrivalent Inactivated Split Virus Influenza Vaccine to Healthy Young Adults.
- ClinicalTrials.gov ID
- NCT03160118
- Acronym / sponsor ID
- BioVacSafe - QIV
- Conditions
- Prevention of Influenza
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent, Max Planck Institute for Infection Biology (MPIIB), Berlin, Germany, deCODE genetics, Iceland, VisMederi srl, Sienna, Italy
- Study start
- 27 Mar 2017 (actual)
- Primary completion
- 17 May 2017 (actual)
- Study completion
- 28 Jun 2017 (actual)
- First posted
- 19 May 2017 (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 clinical fase IV study, using the administration of a single dose of a quadrivalent, inactivated, split influenza virus vaccine as biological intervention will mirror a study conducted at Imperial College, London, UK that will use a challenge with live virus as intervention. Comparison of the clinical observations and laboratory measurements generated in both studies will inform us about the similarities and differences in innate and adaptive immune responses elicited by both types of exposure to influenza virus antigen(s).
Detailed description
The study is a monocentric, open label study. All subjects will receive a single dose of alfa-Rix Tetra 2016-2017. The following will be measured - clinical events (recorded adverse events), physiological responses (heart rate, blood pressure, temperature, injection site), innate immune responses (cytokine levels and whole blood gene expression) and adaptive immune responses (serum antibody and antigen-specific cellular responses) at various time points after immunisation.
At each study visit, full physiological parameters (including body temperature, heart rate, blood pressure) will be obtained and the injection site will be examined for the presence of any redness or swelling that will be measured and recorded. Standardized diary cards will be used to collect solicited and unsolicited clinical event data. At each visit the diary cards will be examined and any relevant clinical event will be entered into the clinical event form. Participants will be asked to monitor oral temperature from day 0 until day 7 when they wake up and when going to bed. The results of these measurements will be reported in a diary card. Any skin reactions at the site of injection will be evaluated; largest diameter of redness and swelling will be measured with a ruler and data reported on the diary card. Samples of blood (PAXgene tubes, plasma, serum and PBMCs (peripheral blood mononuclear cells)) will be collected for analysis and processing using protocols already in place. Subjects will also have blood obtained for standard safety markers (haematology, biochemistry) as well as acute phase proteins.
The purpose of this protocol is to generate a set of data that will be analysed by integrated systems biology approach, for validation in subsequent clinical trials or in animal models. The dataset will broadly characterise:
- Physiological responses at various time points after immunisation by measuring:
- Local and systemic vaccine-related clinical events.
- Physiological assessments: heart rate, body temperature, blood pressure.
- Haematology (Complete Blood Count (CBC), Erythrocyte Sedimentation Rate (ESR) , phenotyping of White Blood Cells (WBC)), biochemistry parameters.
- Innate and adaptive immune responses including:
- Innate immune activation detected by global gene expression in whole blood
- Adaptive immunity determined by:
- Humoral immune response via serum anti-influenza HAI (Haemagglutination Inhibition) titre ii. Cellular immune response c. Immune activation detected by concentration of selected inflammatory soluble mediators in serum including: i. chemokines and cytokines ii. acute phase proteins
- Genetic testing of subjects when deemed necessary (genetic testing analysis may be SNIP (Single Nucleotide Polymorphism) analysis or full genome analysis).
- Correlations in changes in innate and adaptive immune activation with adverse events, haematology and biochemistry panels, genotype and physiological assessments
The study team will biobank all samples for the duration of the BIOVACSAFE programme so that different samples and different time points depending on the results generated can selectively be analysed, principally from the gene expression analysis of whole blood.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Seasonal,quadrivalent,influenza vaccine | Other | Drug: Seasonal,quadrivalent,influenza vaccine1 vaccine will be administered to all participants, namely Alfa-Rix Tetra 2016-2017 |
Who may qualify
- Ages
- 24 to 54 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy male or female subjects aged 24-54 years inclusive. (Healthy in the opinion of the investigator, based on medical history and clinical exam, with no active disease process that could interfere with the study endpoints)
- Has a body Mass Index ≥18 and ≤30
- Is able to read and understand the Informed Consent Form (ICF), and understand study procedures.
- The subject has signed the ICF.
- The subject is available for follow-up for the duration of the study.
Key exclusion criteria (16 listed)
- Pregnant or lactating.
- Known hypersensitivity to any component of the study vaccine (α-RIX-Tetra®): the active components (vaccine antigens) or any of the excipients (disodium phosphate dodecahydrate, potassium dihydrogen phosphate, magnesium chloride hexahydrate, α-tocopheryl hydrogen succinate, polysorbate 80, octoxinol 10), eggs (chicken proteins, ovalbumin), gentamycin sulphate, formaldehyde, and sodium deoxycholate or those who have had a previous life-threatening reaction to previous influenza vaccinations.
- History of influenza infection in the past 5 years, defined here as severe respiratory infection with fever (> 38°C) and preventing normal daily activity during a minimum of 3 days.
- Vaccination with the 2016/2017 seasonal influenza vaccine and/or any other seasonal influenza vaccine within the preceding 5 influenza seasons (i.e. since season 2011/2012) before the first study visit.
- Presence of primary or acquired immunodeficiency states with a total lymphocyte count less than 1,200 per mm3 or presenting other evidence of lack of cellular immune competence e.g. leukaemias, lymphomas, blood dyscrasias, or patients receiving immunosuppressive therapy (including use of oral or parenteral corticosteroids in a dose ≥ 5 mg prednisone daily or equivalent within one month prior to visit 1or cytotoxic or immunosuppressive or immunomodulating drugs within 6 months prior to visit 1).
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 |
|---|---|---|
| Seasonal,quadrivalent,influenza vaccineAlso: Alfa-Rix Tetra 2016-20171 dose to be administered on Day 0, the first visit | Drug | Seasonal,quadrivalent,influenza vaccine |
Primary outcome
Frequency of local vaccine-related clinical events.
Time frame: At all timepoints from vaccination up to 28 days after vaccination
Participants will report these events on a diary, measuring local events or scoring them from 0 (absent) to 3 (severe)
Severity of local vaccine-related clinical events.
Time frame: At all timepoints from time of vaccination up to 28 days after vaccination
Participants will report these events on a diary, measuring local events or scoring them from 0 (absent) to 3 (severe)
Frequency of systemic vaccine-related clinical events.
Time frame: At selected timepoints from time of vaccination up to 28 days after vaccination
Participants will report these events on a diary, scoring the events from 0 (absent) to 3 (severe)
Severity of systemic vaccine-related clinical events.
Time frame: At selected timepoints from time of vaccination up to 28 days after vaccination
Participants will report these events on a diary, scoring the events from 0 (absent) to 3 (severe)
Change from pre-immunisation baseline values in pulse.
Time frame: At selected timepoints from time of vaccination up to 28 days after vaccination
Will be measured during the study visits
Change from pre-immunisation baseline values in body temperature
Time frame: At selected timepoints from time of vaccination up to 28 days after vaccination
Will be measured during the study visits
Change from pre-immunisation baseline values in blood pressure
Time frame: At selected timepoints from time of vaccination up to 28 days after vaccination
Will be measured during the study visits
Change from pre-immunisation baseline values in haematology (CBC, ESR, phenotyping of WBC) parameters
Time frame: At selected timepoints from time of vaccination up to 28 days after vaccination
blood will be collected during the study visits
Change from pre-immunisation baseline values in biochemistry parameters
Time frame: At selected timepoints from time of vaccination up to 28 days after vaccination
blood will be collected during the study visits
Change from pre-immunisation baseline values in global gene expression measured on whole blood samples
Time frame: At selected timepoints from time of vaccination up to 28 days after vaccination
blood will be collected during the study visits
Change from pre-immunisation baseline values in serum HAI titre in serum samples
Time frame: At selected timepoints from time of vaccination up to 28 days after vaccination
blood will be collected during the study visits
Change from pre-immunisation values of adaptive cellular immune response via enumeration of influenza-specific CD4+ T cells expressing activation markers and/or cytokines following in vitro stimulation and analysis by flow cytometry
Time frame: At selected timepoints from time of vaccination up to 28 days after vaccination
blood will be collected during the study visits
Change from pre-immunisation baseline values in concentration of selected cytokines and acute phase proteins in serum samples
Time frame: At selected timepoints from time of vaccination up to 28 days after vaccination
blood will be collected during the study visits
Change from pre-immunisation baseline values in PBMC cytokine secretion, proliferation or surface markers in response to in vitro stimulation with influenza antigens
Time frame: At selected timepoints from time of vaccination up to 28 days after vaccination
blood will be collected during the study visits
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 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Geert Leroux-Roels, Prof., PhD principal investigator
University Ghent / University Hospital Ghent
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 Seasonal,quadrivalent,influenza vaccine in people with Prevention of Influenza, run by University Hospital, Ghent at 1 site in Belgium.
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 9 inclusion and 16 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 Sep 2024. 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 Belgium. 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?
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?
Frequency of local vaccine-related clinical events. (time frame: At all timepoints from vaccination up to 28 days after vaccination). The study lists 14 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 Sep 2024.