Influenza A Virus, H5N1 SubtypePhase 2NCT01910519
Systems Biology of Influenza A (H5N1) Virus Monovalent Vaccine With and Without Adjuvant System 03 (AS03)
A Phase 2 study testing H5N1 vaccine plus AS03 adjuvant and H5N1 vaccine without adjuvant in people with Influenza A Virus, H5N1 Subtype, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
This study will compare the different immune responses to Influenza A (H5N1) Virus Monovalent Vaccine with and without the AS03 adjuvant. The Influenza A (H5N1) Virus Monovalent Vaccine with AS03 adjuvant vaccine is approved for use for adults to protect against flu caused by the A/H5N1 "bird flu" virus in Europe but… Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza A Virus, H5N1 Subtype
- What is being tested?
- H5N1 vaccine plus AS03 adjuvant and H5N1 vaccine without adjuvant
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Nov 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Individuals in good health (as determined by vital signs, medical history, physical examination and laboratory tests);
- Able to understand and give informed consent;
- Women of childbearing potential must agree to practice adequate contraception 1 month prior to study entry and until day 100 of the study.
Who cannot join
- Personal or family history of sleeping disorders including any of the following: Narcolepsy with or without cataplexy; Idiopathic Hypersomnia or excessive daytime sleepiness of unknown origin; Sleep paralysis; Sleep related hallucinations (hypnagogic or hypnopompic hallucinations);
- Human leukocyte antigen (HLA)-DQB1*06:02 positivity (or DQB1*06 positivity if high resolution HLA testing cannot be performed);
- An abnormal erythrocyte sedimentation rate at baseline;
- Receipt of blood products 3 months prior to study entry and until day 100 of the study;
- Volunteers who donated blood 56 days before screening and have plans to donate on or before day 100 of the study;
- Hemoglobin value of less than 12 mg/dL for females and less than 13 mg/dL for males;
Show all 22Show fewer
- A positive result in the Narcolepsy Mini Screen questionnaire;
- A score of ≥11 on the Epworth sleepiness scale questionnaire;
- Receipt of any experimental agents within 6 weeks prior to first vaccination and until the completion of the study;
- Receipt of any licensed live vaccine within 4 weeks or any licensed inactivated vaccine within 2 weeks prior to the first study vaccination or planned receipt of any vaccine within 42 days after study entry;
- Receipt of a H5 vaccine or AS03-adjuvanted vaccine at any time in the past prior to current study or have a history of A/H5N1 infection;
- Influenza-like illness (ILI) or documented influenza infection during the 2013-2014 influenza season. [Not excluded from the study, volunteers with prior upper respiratory infections other than ILI];
- Chronic medical problems including (but not limited to) insulin dependent diabetes, severe heart disease, severe lung disease, severe liver disease, severe kidney disease, autoimmune disease, severe gastrointestinal disease;
- Alcohol or drug abuse and psychiatric conditions that in the opinion of the investigator would preclude compliance with the trial or interpretation of safety or endpoint data;
- Impaired immune function or chronic infections including (but not limited to) HIV, hepatitis B or C; organ transplant; active cancer or any history of hematologic cancer; receipt of chemotherapy, radiation therapy (past 36 months) or any other potentially immunosuppressive therapy [i.e. Systemic steroids at any dose and intra-articular administration of steroids in the past 3 months; (Nasal and topical steroids are allowed)], congenital immunodeficiency, anatomical or functional asplenia;
- Heart rate less than 40 bpm or greater than 100 bpm. Systolic blood pressure is less than 90 mm Hg or equal or greater than 160 mm Hg. Diastolic blood pressure is less than 60 mm Hg or equal or greater than 100 mg Hg;
- Pregnancy or postpartum (less than 1 year after delivery) or breast feeding;
- Severe reactions to prior vaccination with influenza virus vaccines, including anaphylaxis;
- History of Guillain-Barré syndrome;
- A previous sudden life-threatening allergic reaction to any ingredient of Influenza A (H5N1) Virus Monovalent Vaccine with or without AS03 adjuvant or to any of the substances that may be present in trace amounts such as thiomersal, egg residues including ovalbumin as well as residual amounts of sodium deoxycholate detergent, formaldehyde and sucrose;
- Volunteers with any acute illness, including any fever (> 100.4 F [> 38.0 C], regardless of the route) within 3 days prior to study entry;
- Social, occupational, or any other condition that in the opinion of the investigator might interfere with compliance with the study and vaccine evaluation.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Hope Clinic - Emory Vaccine Center
Decatur, Georgia, 30030
About this study
Official title: Systems Biology of Influenza A (H5N1) Virus Monovalent Vaccine With and Without AS03 Adjuvant (HIPC: VAX-010)
This study will compare the different immune responses to Influenza A (H5N1) Virus Monovalent Vaccine with and without the AS03 adjuvant. The Influenza A (H5N1) Virus Monovalent Vaccine with AS03 adjuvant vaccine is approved for use for adults to protect against flu caused by the A/H5N1 "bird flu" virus in Europe but none of the vaccines to be used in the study are approved for use in the United States. The results of this study will help researchers learn about better ways to vaccinate people against the H5N1 flu.
Read the detailed description
The influenza virus (a germ) causes influenza or "flu." The flu is an infection of the breathing tubes and the lungs. In recent years, flu viruses that at first only infected birds have begun to infect humans. One of these strains is called avian influenza (A/H5N1 subtype) or "bird flu". Although no human cases of bird flu have been diagnosed in the United States, this strain has caused severe illness and death in several hundred people since late 2003. .
Vaccination is the most effective way of controlling flu and preventing its illness and complications. Vaccines help prevent illness by causing the body to make antibodies that fight infection. One way to improve the effectiveness of a vaccine is to include a substance that can stimulate the immune system to make more antibodies. This type of substance is called an adjuvant; one type of adjuvant is called AS03 (Adjuvant System 03).
- Conditions
- Influenza A Virus, H5N1 Subtype
- Being tested
- H5N1 vaccine plus AS03 adjuvant, H5N1 vaccine without adjuvant
- Keywords
- influenza A (H5N1) virus, H5N1 influenza, influenza A/H5/N1, monovalent H5N1 influenza vaccine, systems biology, AS03 adjuvant, unadjuvanted
- Medical subject headings
- Influenza in Birds, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H5N1 vaccine plus AS03 adjuvantBiological
Also called Q-Pan H5N1, adjuvanted Q-Pan H5N1
Administered vaccine: [GlaxoSmithKline] Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted.
Participants receive 2 intramuscular doses of Influenza A (H5N1) Virus with AS03 adjuvant, administered 21 (+/- 3) days apart.
H5N1 vaccine without adjuvantBiological
Also called unadjuvanted H5N1 vaccine
Administered vaccine: [GlaxoSmithKline] Influenza A (H5N1) Virus Monovalent Vaccine without AS03 adjuvant.
Participants receive 2 intramuscular doses of Influenza A (H5N1) Virus without adjuvant, administered 21 (+/- 3) days apart.
| Study group | Role | What they receive |
|---|---|---|
| H5N1 vaccine plus AS03 adjuvant | Experimental | H5N1 vaccine plus AS03 adjuvant: Influenza A Vaccine with AS03 adjuvant
Participants receive 2 intramuscular doses of Influenza A (H5N1) Virus Monovalent Vaccine with AS03 adjuvant given 21 days apart (i.e., Administer day 1, booster at Day 21). Receives: Biological: H5N1 vaccine plus AS03 adjuvant |
| H5N1 vaccine without adjuvant | Experimental | H5N1 vaccine without adjuvant: Influenza A Vaccine without AS03 adjuvant
Participants receive 2 intramuscular doses of Influenza A (H5N1) Virus Monovalent Vaccine without AS03 adjuvant given 21 days apart (i.e., Administer day 1, booster at Day 21). Receives: Biological: H5N1 vaccine without adjuvant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Traditional Immune Parameters Measurements Using Luminex Assays and Gene Expression Measurement Using Microarray Experiments From Baseline With Influenza A Vaccine With and Without AS03 Adjuvant
To identify innate immune signatures; 1 day post first vaccination
Measured: Day 1
Change in Traditional Immune Parameters Measurements Using Luminex Assays and Gene Expression Measurement Using Microarray Experiments From Baseline With Influenza A Vaccine With and Without AS03 Adjuvant
To identify innate immune signatures; 3 days post first vaccination
Measured: Day 3
Change in Traditional Immune Parameters Measurements Using Luminex Assays and Gene Expression Measurement Using Microarray Experiments From Baseline With Influenza A Vaccine With and Without AS03 Adjuvant
To identify innate immune signatures; 7 days post first vaccination
Measured: Day 7
Change in Traditional Immune Parameters Measurements Using Luminex Assays and Gene Expression Measurement Using Microarray Experiments From Baseline With Influenza A Vaccine With and Without AS03 Adjuvant
To identify innate immune signatures; 1 day post second vaccination
Measured: Day 22
Change in Traditional Immune Parameters Measurements Using Luminex Assays and Gene Expression Measurement Using Microarray Experiments From Baseline With Influenza A Vaccine With and Without AS03 Adjuvant
To identify innate immune signatures; 3 days post second vaccination
Measured: Day 24
Change in Traditional Immune Parameters Measurements Using Luminex Assays and Gene Expression Measurement Using Microarray Experiments From Baseline With Influenza A Vaccine With and Without AS03 Adjuvant
To identify innate immune signatures; 7 days post second vaccination
Measured: Day 28
Measurement of Hemagglutination Inhibition Assay (HAI) Titers With Influenza A Vaccine With and Without AS03 Adjuvant
To measure selective adaptive immune response; 21 days post first vaccination
Measured: Day 21
Measurement of Microneutralization (MN) Titers With Influenza A Vaccine With and Without AS03 Adjuvant
To measure selective adaptive immune response; 21 days post first vaccination
Measured: Day 21
Measurement of Hemagglutination Inhibition Assay (HAI) Titers With Influenza A Vaccine With and Without AS03 Adjuvant
To measure selective adaptive immune response; 21 days post second vaccination
Measured: Day 42
Measurement of Microneutralization (MN) Titers With Influenza A Vaccine With and Without AS03 Adjuvant
To measure selective adaptive immune response; 21 days post second vaccination
Measured: Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionFeb 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Influenza A Virus, H5N1 SubtypeStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Emory University
- Responsible party
- Sponsor
- Investigators
- Nadine Rouphael, MD, Principal investigator, Hope Clinic, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01910519
- Sponsor's protocol ID
- DAIT HIPC: VAX-010
- Other IDs
- 1U19AI090023-01
- Status last verified
- Jan 2019
- First submitted
- 23 Jul 2013
- Last updated
- 12 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Wimmers F, Donato M, Kuo A, Ashuach T, Gupta S, Li C, Dvorak M, Foecke MH, Chang SE, Hagan T, De Jong SE, Maecker HT, van der Most R, Cheung P, Cortese M, Bosinger SE, Davis M, Rouphael N, Subramaniam S, Yosef N, Utz PJ, Khatri P, Pulendran B. The single-cell epigenomic and transcriptional landscape of immunity to influenza vaccination. Cell. 2021 Jul 22;184(15):3915-3935.e21. doi: 10.1016/j.cell.2021.05.039. Epub 2021 Jun 25.
PubMed 34174187
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systems Biology of Influenza A (H5N1) Virus Monovalent Vaccine With and Without AS03 Adjuvant (HIPC: VAX-010)
- ClinicalTrials.gov ID
- NCT01910519
- Acronym / sponsor ID
- DAIT HIPC: VAX-010
- Conditions
- Influenza A Virus, H5N1 Subtype
- Keywords
- influenza A (H5N1) virus, H5N1 influenza, influenza A/H5/N1, monovalent H5N1 influenza vaccine, systems biology, AS03 adjuvant, unadjuvanted
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Emory University
- Study start
- Jul 2013 (actual)
- Primary completion
- Feb 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 29 Jul 2013 (estimated)
- Results
- Posted 12 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the different immune responses to Influenza A (H5N1) Virus Monovalent Vaccine with and without the AS03 adjuvant. The Influenza A (H5N1) Virus Monovalent Vaccine with AS03 adjuvant vaccine is approved for use for adults to protect against flu caused by the A/H5N1 "bird flu" virus in Europe but none of the vaccines to be used in the study are approved for use in the United States. The results of this study will help researchers learn about better ways to vaccinate people against the H5N1 flu.
Detailed description
The influenza virus (a germ) causes influenza or "flu." The flu is an infection of the breathing tubes and the lungs. In recent years, flu viruses that at first only infected birds have begun to infect humans. One of these strains is called avian influenza (A/H5N1 subtype) or "bird flu". Although no human cases of bird flu have been diagnosed in the United States, this strain has caused severe illness and death in several hundred people since late 2003. .
Vaccination is the most effective way of controlling flu and preventing its illness and complications. Vaccines help prevent illness by causing the body to make antibodies that fight infection. One way to improve the effectiveness of a vaccine is to include a substance that can stimulate the immune system to make more antibodies. This type of substance is called an adjuvant; one type of adjuvant is called AS03 (Adjuvant System 03).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| H5N1 vaccine plus AS03 adjuvant | Experimental | Biological: H5N1 vaccine plus AS03 adjuvantH5N1 vaccine plus AS03 adjuvant: Influenza A Vaccine with AS03 adjuvant Participants receive 2 intramuscular doses of Influenza A (H5N1) Virus Monovalent Vaccine with AS03 adjuvant given 21 days apart (i.e., Administer day 1, booster at Day 21). |
| H5N1 vaccine without adjuvant | Experimental | Biological: H5N1 vaccine without adjuvantH5N1 vaccine without adjuvant: Influenza A Vaccine without AS03 adjuvant Participants receive 2 intramuscular doses of Influenza A (H5N1) Virus Monovalent Vaccine without AS03 adjuvant given 21 days apart (i.e., Administer day 1, booster at Day 21). |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Individuals in good health (as determined by vital signs, medical history, physical examination and laboratory tests);
- Able to understand and give informed consent;
- Women of childbearing potential must agree to practice adequate contraception 1 month prior to study entry and until day 100 of the study.
Key exclusion criteria (22 listed)
- Personal or family history of sleeping disorders including any of the following: Narcolepsy with or without cataplexy; Idiopathic Hypersomnia or excessive daytime sleepiness of unknown origin; Sleep paralysis; Sleep related hallucinations (hypnagogic or hypnopompic hallucinations);
- Human leukocyte antigen (HLA)-DQB1*06:02 positivity (or DQB1*06 positivity if high resolution HLA testing cannot be performed);
- An abnormal erythrocyte sedimentation rate at baseline;
- Receipt of blood products 3 months prior to study entry and until day 100 of the study;
- Volunteers who donated blood 56 days before screening and have plans to donate on or before day 100 of the study;
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 |
|---|---|---|
| H5N1 vaccine plus AS03 adjuvantAlso: Q-Pan H5N1, adjuvanted Q-Pan H5N1Administered vaccine: [GlaxoSmithKline] Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted. Participants receive 2 intramuscular doses of Influenza A (H5N1) Virus with AS03 adjuvant, administered 21 (+/- 3) days apart. | Biological | H5N1 vaccine plus AS03 adjuvant |
| H5N1 vaccine without adjuvantAlso: unadjuvanted H5N1 vaccineAdministered vaccine: [GlaxoSmithKline] Influenza A (H5N1) Virus Monovalent Vaccine without AS03 adjuvant. Participants receive 2 intramuscular doses of Influenza A (H5N1) Virus without adjuvant, administered 21 (+/- 3) days apart. | Biological | H5N1 vaccine without adjuvant |
Primary outcome
Change in Traditional Immune Parameters Measurements Using Luminex Assays and Gene Expression Measurement Using Microarray Experiments From Baseline With Influenza A Vaccine With and Without AS03 Adjuvant
Time frame: Day 1
To identify innate immune signatures; 1 day post first vaccination
Change in Traditional Immune Parameters Measurements Using Luminex Assays and Gene Expression Measurement Using Microarray Experiments From Baseline With Influenza A Vaccine With and Without AS03 Adjuvant
Time frame: Day 3
To identify innate immune signatures; 3 days post first vaccination
Change in Traditional Immune Parameters Measurements Using Luminex Assays and Gene Expression Measurement Using Microarray Experiments From Baseline With Influenza A Vaccine With and Without AS03 Adjuvant
Time frame: Day 7
To identify innate immune signatures; 7 days post first vaccination
Change in Traditional Immune Parameters Measurements Using Luminex Assays and Gene Expression Measurement Using Microarray Experiments From Baseline With Influenza A Vaccine With and Without AS03 Adjuvant
Time frame: Day 22
To identify innate immune signatures; 1 day post second vaccination
Change in Traditional Immune Parameters Measurements Using Luminex Assays and Gene Expression Measurement Using Microarray Experiments From Baseline With Influenza A Vaccine With and Without AS03 Adjuvant
Time frame: Day 24
To identify innate immune signatures; 3 days post second vaccination
Change in Traditional Immune Parameters Measurements Using Luminex Assays and Gene Expression Measurement Using Microarray Experiments From Baseline With Influenza A Vaccine With and Without AS03 Adjuvant
Time frame: Day 28
To identify innate immune signatures; 7 days post second vaccination
Measurement of Hemagglutination Inhibition Assay (HAI) Titers With Influenza A Vaccine With and Without AS03 Adjuvant
Time frame: Day 21
To measure selective adaptive immune response; 21 days post first vaccination
Measurement of Microneutralization (MN) Titers With Influenza A Vaccine With and Without AS03 Adjuvant
Time frame: Day 21
To measure selective adaptive immune response; 21 days post first vaccination
Measurement of Hemagglutination Inhibition Assay (HAI) Titers With Influenza A Vaccine With and Without AS03 Adjuvant
Time frame: Day 42
To measure selective adaptive immune response; 21 days post second vaccination
Measurement of Microneutralization (MN) Titers With Influenza A Vaccine With and Without AS03 Adjuvant
Time frame: Day 42
To measure selective adaptive immune response; 21 days post second vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34174187Wimmers F, Donato M, Kuo A, Ashuach T, Gupta S, Li C, Dvorak M, Foecke MH, Chang SE, Hagan T, De Jong SE, Maecker HT, van der Most R, Cheung P, Cortese M, Bosinger SE, Davis M, Rouphael N, Subramaniam S, Yosef N, Utz PJ, Khatri P, Pulendran B. The single-cell epigenomic and transcriptional landscape of immunity to influenza vaccination. Cell. 2021 Jul 22;184(15):3915-3935.e21. doi: 10.1016/j.cell.2021.05.039. Epub 2021 Jun 25.
- National Institute of Allergy and Infectious Diseases (NIAID)Link 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.
Nadine Rouphael, MD principal investigator
Hope Clinic, Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing H5N1 vaccine plus AS03 adjuvant and H5N1 vaccine without adjuvant in people with Influenza A Virus, H5N1 Subtype, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 22 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 12 Feb 2019. 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 United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Traditional Immune Parameters Measurements Using Luminex Assays and Gene Expression Measurement Using Microarray Experiments From Baseline With Influenza A Vaccine With and Without AS03 Adjuvant (time frame: Day 1). The study lists 10 primary outcomes in all. 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 NCT01910519, which also lists 1 linked publication.
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 12 Feb 2019.