Encephalitis, Japanese BPhase 3NCT00249769
Determining Safety and Efficacy of Japanese Encephalitis Vaccine When Given With Measles Vaccine
A Phase 3 study testing Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) and Measles Vaccine (MV) in people with Encephalitis, Japanese B, run by PATH at 1 site in Philippines.
Trial summary
This study will determine whether it is safe and effective to administer Japanese encephalitis (JE) live attenuated SA 14-14-2 vaccine at the same time as measles vaccine. If it is found to be safe, it will pave the way for use in routine vaccination programs. Read more about this study
- Who is it for?
- Ages 8 to 11 monthsHealthy volunteers can take part
- Conditions the study is for
- Encephalitis, Japanese B
- What is being tested?
- Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) and Measles Vaccine (MV)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 sitePhilippines
- Study dates
- 21 Nov 2005to 30 May 2006
- Phase
- Phase 3
- 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 8 to 11 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participant is healthy, aged between 8 months (± 2 weeks) at inclusion visit
- Subject is a full-term infant
- Subject's parents or legal guardian willing to provide signed informed consent.
- Children have completed 3 doses each of diphtheria, tetanus, pertussis (DTP) and oral polio vaccine (OPV).
Who cannot join
- History of documented HIV.
- Known or suspected impairment of immunologic function.
- History of serious chronic disease
- Underlying medical condition such as inborn errors of metabolism, failure to thrive, bronchopulmonary dysplasia, or any major congenital abnormalities requiring surgery or chronic treatment.
- Acute medical illness with or without fever within the last 72 hours or an axillary temperature ≥ 37.5°C at the time of inclusion.
- History of documented suspected encephalitis, encephalopathy, or meningitis
Show all 19Show fewer
- History of measles
- History of thrombocytopenic purpura.
- Received any JE or measles vaccine prior to enrollment.
- Received any vaccine, other than the study vaccines, within 2 weeks prior to or scheduled to receive a non-study vaccination during the conduct of this trial.
- Hypotonic - hyporesponsiveness, after the preceding vaccination.
- History of seizures, including history of febrile seizures, or any other neurologic disorder.
- Prior or anticipated receipt of immune globulin or other blood products, or injected or oral corticosteroids or other immune modulator therapy except routine vaccines within 6 weeks of administration of the study vaccines. Individuals on a tapering dose schedule of oral steroids lasting <7 days may be included in the trial as long as they have not received more than one course within the last 2 weeks prior to enrollment.
- Suspected or known hypersensitivity to any of the investigational or marketed vaccine components.
- Serious adverse event related to the vaccine (i.e., possible, probably, definite)
- Persistent inconsolable crying (>3 hours) observed after a previous dose.
- Unable to attend the scheduled visits or comply with the study procedures.
- Enrolled in another clinical trial involving any therapy.
- Any condition that in the opinion of the investigator, would pose a health risk to the participant, or interfere with the evaluation of the study objectives.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Non-Inferiority of the Concurrent Administration of Japanese Encephalitis Live Attenuated SA 14-14-2 Vaccine and Measles Vaccine Given Alone
This study will determine whether it is safe and effective to administer Japanese encephalitis (JE) live attenuated SA 14-14-2 vaccine at the same time as measles vaccine. If it is found to be safe, it will pave the way for use in routine vaccination programs. The hypothesis is that children who receive JE live attenuated SA 14-14-2 vaccine and measles vaccine at the same time are protected against these diseases at the same level as those who receive the vaccines at different intervals.
Read the detailed description
Japanese encephalitis is the leading cause of viral neurological disease and disability in Asia. The severity of sequelae, together with the volume of cases, make JE the most important cause of viral encephalitis in the world. Approximately 3 billion people-including 700 million children-live in Asian areas at risk for JE. JE most commonly infects children between the ages of 1 and 15 years, and can also infect adults in areas where the virus is newly introduced. More than 50,000 cases are reported annually and cause an estimated 10,000 to 15,000 deaths. This figure is believed to represent only a small proportion of the disease burden that actually exists.
An effective vaccine has existed since 1941, but has not reached the poorest countries in Asia. During the 60 years that the vaccine has been available, JE has infected an estimated 10.5 million children, resulting in more than 3 million deaths and more than 4 million children living with long-term disabilities. Control of this disease has been limited due to poor disease surveillance, a limited and unstable vaccine supply, lack of guidance and programmatic support for immunization, and limited advocacy.
A successful vaccine should be safe, efficacious, affordable, administered in a single dose, and easily incorporated into the routine Expanded Programmes on Immunization (EPI) programs. This study will help ensure the safety of SA 14-14-2 simultaneously administered with measles vaccine, paving the way for its use in routine EPI programs. If this candidate becomes widely available, it will drastically increase the feasibility of routine JE immunization in Asia, reducing the devastating death and disability caused by this disease. In addition to impacting low-income countries, the vaccine will allow countries that purchase vaccine-such as Thailand, Vietnam, Sri Lanka, and India-to recover health care dollars, improve their present programs, and address other unmet health care needs.
- Conditions
- Encephalitis, Japanese B
- Being tested
- Live Japanese encephalitis vaccine SA 14-14-2 (LJEV), Measles Vaccine (MV)
- Keywords
- Japanese Encephalitis, Japanese B Encephalitis, Japanese B Viral Encephalitis, Viral Encephalitis, Japanese B
- Medical subject headings
- Encephalitis, Japanese
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live Japanese encephalitis vaccine SA 14-14-2 (LJEV)Biological
Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) is lyophilized powder that looks like a milky-white crisp cake. After reconstitution, it turns into a transparent orange red liquid. Its container is a vial. It is stored and transported between 2°C to 8°C and protected from light. Each single human dose is 0.5 ml containing not less than 5.4 log particle flux unit (PFU) of live Japanese Encephalitis (JE) virus. The 0.5ml injection is delivered subcutaneously via auto-disable syringe. Lot number 200411129-3 manufactured by Chengdu Institute of Biological Products (CDIBP), Chengdu, China.
Measles Vaccine (MV)Biological
The Serum Institute of India (SII) measles vaccine provided routinely in the Expanded Program on Immunization (EPI) of the Philippines was the measles vaccine provided to the study participants. The vaccine met the requirements of the World Health Organization (WHO).
SII measles vaccine contained live attenuated (freeze-dried) Edmonston-Zagreb strain measles virus propagated on human diploid cells (HDC). Each single human dose when reconstituted in a volume of 0.5 ml contains no less than 1000 Cell culture infectious dose 50% (CCID50) of live virus particles. SII measles vaccine is presented as a yellowish-white dry cake. The vaccine should be reconstituted with the diluent supplied (sterile water for injection). A sterile disposable syringe and needle are supplied separately. The 0.5ml injection is delivered subcutaneously via auto-disable syringe. Lot number 2979.
| Study group | Role | What they receive |
|---|---|---|
| LJEV then MV | Experimental | Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) at 8 months of age, and one dose of measles vaccine (MV) one month later. Receives: Biological: Live Japanese encephalitis vaccine SA 14-14-2 (LJEV); Biological: Measles Vaccine (MV) |
| LJEV and MV | Experimental | Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) concurrently with one dose of measles vaccine (MV) at 9 months of age. Receives: Biological: Live Japanese encephalitis vaccine SA 14-14-2 (LJEV); Biological: Measles Vaccine (MV) |
| MV then LJEV | Experimental | Received one dose of measles vaccine (MV) at 9 months of age, followed by one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) one month later. Receives: Biological: Live Japanese encephalitis vaccine SA 14-14-2 (LJEV); Biological: Measles Vaccine (MV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Seroprotection for Measles 4 Weeks After Vaccination
Seroprotection after measles vaccination was defined as a measles antibody titer ≥ 120 mIU/mL. Measles immunoglobulin G (IgG) antibody was determined using the Enzygnost® Anti-Measles Virus/IgG enzyme-linked immunosorbent assay(ELISA) assay from Siemens, Marburg, Germany.
Measured: Day 0 (before vaccination) and Day 28 (4 weeks after measles vaccination)
Secondary outcomes (6)
Percentage of Participants With Seroprotection for Japanese Encephalitis 4 Weeks After Vaccination
Seroprotection after LJEV was defined as at least 1:10 dilution as recommended by the World Health Organization (WHO). JE antibody titers were determined by a plaque reduction neutralization test (PRNT).
Measured: Day 0 (before vaccination) and Day 28 (4 weeks after LJEV vaccination)
Geometric Mean Concentration (GMC) of Measles Antibodies After Vaccination
Measured using the Enzygnost® Anti-Measles Virus/IgG ELISA assay from Siemens, Marburg, Germany.
Measured: Day 0 (before vaccination) and Day 28 (4 weeks after measles vaccination)
Geometric Mean Titer (GMT) of Japanese Encephalitis Antibodies After Vaccination
Assayed by plaque reduction neutralization test (PRNT).
Measured: Day 0 (before vaccination) and Day 28 (4 weeks after LJEV vaccination)
Number of Participants Experiencing Local and Systemic Reactogenicity After Receiving Live Attenuated Japanese Encephalitis Vaccine (LJEV)
Local reactions included erythema, pain, swelling, or induration. Systemic reactions included loss of appetite, crying, diarrhea, drowsiness, insomnia, irritability, vomiting, or fever. The parents of the participants recorded all local reactions and systemic events on an individual safety diary form.
Measured: Up to 7 days after LJEV administration
Number of Participants Experiencing Local and Systemic Reactogenicity After Receiving Measles Vaccine
Local reactions included erythema, pain, swelling, and induration. Systemic reactions included loss of appetite, crying, diarrhea, drowsiness, insomnia, irritability, and vomiting. The parents of the participants recorded all local reactions and systemic events on an individual safety diary form.
Measured: Up to 7 days after measles vaccination
Number of Participants Experiencing Unsolicited Adverse Events (AE)
Measured: Up to 7 days post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2005 (estimated)
- Study start21 Nov 2005
- Primary completion30 May 2006
- Study completion30 May 2006
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 Encephalitis, Japanese BStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Collaborators
- Research Institute for Tropical Medicine, Manila, Philippines, Quintiles, Inc., Mahidol University
- Responsible party
- Sponsor
- Investigators
- Salvacion Gatchalian, MD, Principal investigator, Research Institute for Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00249769
- Sponsor's protocol ID
- JEV01
- Status last verified
- Sep 2018
- First submitted
- 3 Nov 2005
- Last updated
- 10 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Gatchalian S, Yao Y, Zhou B, Zhang L, Yoksan S, Kelly K, Neuzil KM, Yaich M, Jacobson J. Comparison of the immunogenicity and safety of measles vaccine administered alone or with live, attenuated Japanese encephalitis SA 14-14-2 vaccine in Philippine infants. Vaccine. 2008 Apr 24;26(18):2234-41. doi: 10.1016/j.vaccine.2008.02.042. Epub 2008 Mar 18.
PubMed 18394765
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Non-Inferiority of the Concurrent Administration of Japanese Encephalitis Live Attenuated SA 14-14-2 Vaccine and Measles Vaccine Given Alone
- ClinicalTrials.gov ID
- NCT00249769
- Acronym / sponsor ID
- JEV01
- Conditions
- Encephalitis, Japanese B
- Keywords
- Japanese Encephalitis, Japanese B Encephalitis, Japanese B Viral Encephalitis, Viral Encephalitis, Japanese B
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- PATHUniversity, hospital or other
- Collaborators
- Research Institute for Tropical Medicine, Manila, Philippines, Quintiles, Inc., Mahidol University
- Study start
- 21 Nov 2005 (actual)
- Primary completion
- 30 May 2006 (actual)
- Study completion
- 30 May 2006 (actual)
- First posted
- 7 Nov 2005 (estimated)
- Results
- Posted 10 Mar 2020
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 determine whether it is safe and effective to administer Japanese encephalitis (JE) live attenuated SA 14-14-2 vaccine at the same time as measles vaccine. If it is found to be safe, it will pave the way for use in routine vaccination programs. The hypothesis is that children who receive JE live attenuated SA 14-14-2 vaccine and measles vaccine at the same time are protected against these diseases at the same level as those who receive the vaccines at different intervals.
Detailed description
Japanese encephalitis is the leading cause of viral neurological disease and disability in Asia. The severity of sequelae, together with the volume of cases, make JE the most important cause of viral encephalitis in the world. Approximately 3 billion people-including 700 million children-live in Asian areas at risk for JE. JE most commonly infects children between the ages of 1 and 15 years, and can also infect adults in areas where the virus is newly introduced. More than 50,000 cases are reported annually and cause an estimated 10,000 to 15,000 deaths. This figure is believed to represent only a small proportion of the disease burden that actually exists.
An effective vaccine has existed since 1941, but has not reached the poorest countries in Asia. During the 60 years that the vaccine has been available, JE has infected an estimated 10.5 million children, resulting in more than 3 million deaths and more than 4 million children living with long-term disabilities. Control of this disease has been limited due to poor disease surveillance, a limited and unstable vaccine supply, lack of guidance and programmatic support for immunization, and limited advocacy.
A successful vaccine should be safe, efficacious, affordable, administered in a single dose, and easily incorporated into the routine Expanded Programmes on Immunization (EPI) programs. This study will help ensure the safety of SA 14-14-2 simultaneously administered with measles vaccine, paving the way for its use in routine EPI programs. If this candidate becomes widely available, it will drastically increase the feasibility of routine JE immunization in Asia, reducing the devastating death and disability caused by this disease. In addition to impacting low-income countries, the vaccine will allow countries that purchase vaccine-such as Thailand, Vietnam, Sri Lanka, and India-to recover health care dollars, improve their present programs, and address other unmet health care needs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LJEV then MV | Experimental | Biological: Live Japanese encephalitis vaccine SA 14-14-2 (LJEV), Biological: Measles Vaccine (MV)Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) at 8 months of age, and one dose of measles vaccine (MV) one month later. |
| LJEV and MV | Experimental | Biological: Live Japanese encephalitis vaccine SA 14-14-2 (LJEV), Biological: Measles Vaccine (MV)Received one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) concurrently with one dose of measles vaccine (MV) at 9 months of age. |
| MV then LJEV | Experimental | Biological: Live Japanese encephalitis vaccine SA 14-14-2 (LJEV), Biological: Measles Vaccine (MV)Received one dose of measles vaccine (MV) at 9 months of age, followed by one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) one month later. |
Who may qualify
- Ages
- 8 to 11 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Participant is healthy, aged between 8 months (± 2 weeks) at inclusion visit
- Subject is a full-term infant
- Subject's parents or legal guardian willing to provide signed informed consent.
- Children have completed 3 doses each of diphtheria, tetanus, pertussis (DTP) and oral polio vaccine (OPV).
Key exclusion criteria (19 listed)
- History of documented HIV.
- Known or suspected impairment of immunologic function.
- History of serious chronic disease
- Underlying medical condition such as inborn errors of metabolism, failure to thrive, bronchopulmonary dysplasia, or any major congenital abnormalities requiring surgery or chronic treatment.
- Acute medical illness with or without fever within the last 72 hours or an axillary temperature ≥ 37.5°C at the time of inclusion.
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 |
|---|---|---|
| Live Japanese encephalitis vaccine SA 14-14-2 (LJEV)Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) is lyophilized powder that looks like a milky-white crisp cake. After reconstitution, it turns into a transparent orange red liquid. Its container is a vial. It is stored and transported between 2°C to 8°C and protected from light. Each single human dose is 0.5 ml containing not less than 5.4 log particle flux unit (PFU) of live Japanese Encephalitis (JE) virus. The 0.5ml injection is delivered subcutaneously via auto-disable syringe. Lot number 200411129-3 manufactured by Chengdu Institute of Biological Products (CDIBP), Chengdu, China. | Biological | LJEV and MV, LJEV then MV, MV then LJEV |
| Measles Vaccine (MV)The Serum Institute of India (SII) measles vaccine provided routinely in the Expanded Program on Immunization (EPI) of the Philippines was the measles vaccine provided to the study participants. The vaccine met the requirements of the World Health Organization (WHO). SII measles vaccine contained live attenuated (freeze-dried) Edmonston-Zagreb strain measles virus propagated on human diploid cells (HDC). Each single human dose when reconstituted in a volume of 0.5 ml contains no less than 1000 Cell culture infectious dose 50% (CCID50) of live virus particles. SII measles vaccine is presented as a yellowish-white dry cake. The vaccine should be reconstituted with the diluent supplied (sterile water for injection). A sterile disposable syringe and needle are supplied separately. The 0.5ml injection is delivered subcutaneously via auto-disable syringe. Lot number 2979. | Biological | LJEV and MV, LJEV then MV, MV then LJEV |
Primary outcome
Percentage of Participants With Seroprotection for Measles 4 Weeks After Vaccination
Time frame: Day 0 (before vaccination) and Day 28 (4 weeks after measles vaccination)
Seroprotection after measles vaccination was defined as a measles antibody titer ≥ 120 mIU/mL. Measles immunoglobulin G (IgG) antibody was determined using the Enzygnost® Anti-Measles Virus/IgG enzyme-linked immunosorbent assay(ELISA) assay from Siemens, Marburg, Germany.
6 secondary outcomes
Percentage of Participants With Seroprotection for Japanese Encephalitis 4 Weeks After Vaccination
Time frame: Day 0 (before vaccination) and Day 28 (4 weeks after LJEV vaccination)
Geometric Mean Concentration (GMC) of Measles Antibodies After Vaccination
Time frame: Day 0 (before vaccination) and Day 28 (4 weeks after measles vaccination)
Geometric Mean Titer (GMT) of Japanese Encephalitis Antibodies After Vaccination
Time frame: Day 0 (before vaccination) and Day 28 (4 weeks after LJEV vaccination)
Number of Participants Experiencing Local and Systemic Reactogenicity After Receiving Live Attenuated Japanese Encephalitis Vaccine (LJEV)
Time frame: Up to 7 days after LJEV administration
Number of Participants Experiencing Local and Systemic Reactogenicity After Receiving Measles Vaccine
Time frame: Up to 7 days after measles vaccination
Number of Participants Experiencing Unsolicited Adverse Events (AE)
Time frame: Up to 7 days post-vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 18394765Gatchalian S, Yao Y, Zhou B, Zhang L, Yoksan S, Kelly K, Neuzil KM, Yaich M, Jacobson J. Comparison of the immunogenicity and safety of measles vaccine administered alone or with live, attenuated Japanese encephalitis SA 14-14-2 vaccine in Philippine infants. Vaccine. 2008 Apr 24;26(18):2234-41. doi: 10.1016/j.vaccine.2008.02.042. Epub 2008 Mar 18.
Related trials for Encephalitis, Japanese B
RecruitingObservational study
Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective
Dengue, Chikungunya
Not yet recruitingObservational study
Diagnostics and Surveillance of Acute Meningo-encephalitis Among Children in Cambodia With a Focus on Japanese Encephalitis Virus
Japanese Encephalitis
Active, not recruitingPhase 4
Monitoring JE Antibody Levels in Healthy Populations and Immunization Strategy in Low-Prevalence Areas
Japanese Encephalitis
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.
Salvacion Gatchalian, MD principal investigator
Research Institute for Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) and Measles Vaccine (MV) in people with Encephalitis, Japanese B, run by PATH at 1 site in Philippines.
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 4 inclusion and 19 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 10 Mar 2020. 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 Philippines. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 10 Mar 2020). 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?
Percentage of Participants With Seroprotection for Measles 4 Weeks After Vaccination (time frame: Day 0 (before vaccination) and Day 28 (4 weeks after measles vaccination)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00249769, 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 10 Mar 2020.