VaccinationNCT02898688
P3+ Intervention Phase
A study testing Intervention Site and Patient-level Intervention Group in people with Vaccination, run by Emory University at 23 sites in United States.
Trial summary
This study will address vaccine uptake both for pregnant women and for their children, through 20 months of age, to test the hypothesis that exposure to the P3+ intervention package will increase the likelihood a pregnant woman gets herself vaccinated against influenza and pertussis before delivery and get her child… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaccination
- What is being tested?
- Intervention Site and Patient-level Intervention Group
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,200 participants
- Where
- 23 sitesUnited States
- Study dates
- 12 Jun 2017to 6 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Have not previously participated in this study
- Currently pregnant
- Up to 26 weeks gestational age
- Able to understand and communicate in English
Who cannot join
- Have received pertussis vaccine during the current pregnancy
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Atlanta Women's Specialists
Alpharetta, Georgia, 30005
Roswell Ob/Gyn
Alpharetta, Georgia, 30005
Athens Midwifery
Athens, Georgia, 30606
Athens Ob-Gyn
Athens, Georgia, 30606
Women's Healthcare Associates of Athens
Athens, Georgia, 30606
Emory Clinic
Atlanta, Georgia, 30322
Riverbend OB/GYN and Counseling
Atlanta, Georgia, 30342
CU Center for Midwifery
Aurora, Colorado, 80045
CU Maternal and Fetal Medicine Clinic
Aurora, Colorado, 80045
University Nurse Midwives
Aurora, Colorado, 80045
Boulder Women's Care
Boulder, Colorado, 80303
Peachtree Women's Clinic
Cumming, Georgia, 30041
St. Joe's Midwives
Denver, Colorado, 80218
Partners in Women's Health at Rose
Denver, Colorado, 80220
Rocky Mountain OBGYN
Denver, Colorado, 80220
Comprehensive Women's OB/GYN
Duluth, Georgia, 30096
Dunwoody Ob-Gyn
Dunwoody, Georgia, 30338
Colorado Mountain Medical
Edwards, Colorado, 81632
Bella Natural Women's Care
Englewood, Colorado, 80113
Associates in Women's Health
Golden, Colorado, 80401
Atlanta Gynecology & Obstetrics
Lilburn, Georgia, 30047
Women's Health Group Thornton
Thornton, Colorado, 80229
Women's Medical Center
Tyrone, Georgia, 30290
About this study
Official title: A Comprehensive Pre-Natal Intervention to Increase Vaccine Coverage (P3+): Practice, Provider, Patient Level Interventions
This study will address vaccine uptake both for pregnant women and for their children, through 20 months of age, to test the hypothesis that exposure to the P3+ intervention package will increase the likelihood a pregnant woman gets herself vaccinated against influenza and pertussis before delivery and get her child vaccinated on time. This study builds off of a prior intervention, developed by Emory, at the practice, provider, and patient levels (P3) to develop, implement and evaluate an enhanced intervention (P3+) to improve vaccination uptake among pregnant women, and later, their children.
Read the detailed description
This study will address vaccine uptake both for pregnant women and for their children, through 20 months of age, to test the hypothesis that exposure to the P3+ intervention package will increase the likelihood a pregnant woman gets herself vaccinated against influenza and pertussis before delivery and get her child vaccinated on time.
This study uses a multi-level factorial design which randomizes at both the practice and the patient level. Obstetric practices in Georgia and Colorado will be randomized to be either an intervention practice or a control practice. The women recruited in the practices and enrolled in the study will be randomly assigned to the intervention arm or the control arm.
Women randomized to the intervention arm will complete a computer-based questionnaire (administered via iPad with a preloaded study app) which asks for their basic demographic and contact information and asks questions about their vaccine knowledge, attitudes, and beliefs. Immediately following the questionnaire, participants will receive the individual level intervention (videos providing information on vaccines) on the same iPad. In order to best answer their questions and not provide information beyond the scope of what the study participants need or want, the videos provided to each participant will be selected based on responses to the survey questions. There are 6 videos: one discusses the dangers of the diseases prevented by vaccines, and the others address specific vaccine concerns (concerns include vaccine ingredients, children receiving simultaneous vaccines (multiple vaccines at one time), and the safety of receiving the tdap or flu vaccine during pregnancy). If the participant does not have any concerns, they will only see the video about dangers of vaccine preventable diseases. Participants expressing concerns in the survey will receive up to two videos addressing those concerns, based on an order of priority determined by the study researchers.
Women randomized to the control arm will also complete a computer-based questionnaire which includes their personal information and vaccine knowledge, attitudes, and beliefs questions but will then continue to receive usual prenatal care rather than view informational videos.
All enrolled women complete two follow-up surveys when their children are 30 days and 18 months of age.
- Conditions
- Vaccination
- Being tested
- Control Site, Intervention Site, Patient-level Control Group, Patient-level Intervention Group
- Keywords
- Influenza vaccine, Pertussis vaccine, Perinatal vaccination, Infant vaccination
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control SiteBehavioural
Also called Practice/provider-Level Control
Control sites will continue with their standard practice regarding discussing vaccines with their patients.
Intervention SiteBehavioural
Also called Practice/provider-Level Intervention
Intervention Sites will each assign a Vaccine Champion and will have Assessment, Feedback, Incentives, and eXchange (AFIX) visits. AFIX is a quality improvement program to raise immunization coverage levels, reduce missed opportunities to vaccinate, and improve standards of practices at the provider level. A Continuing Medical Education (CME) module will be given to all providers, covering the recommended maternal vaccinations and how to talk to patients about vaccines. Intervention sites will have access to written materials covering all recommended maternal and infant vaccinations, the diseases they prevent, potential adverse reactions and common patient questions with talking points and references for each topic.
Patient-level Control GroupBehavioural
Participants randomized the control arm will complete a computer-based questionnaire, on an iPad with a preloaded app. The questionnaire asks about vaccine knowledge, attitudes, and beliefs and the participant's intent to receive vaccinations during pregnancy and to vaccinate their baby. The questionnaire includes questions requiring a "yes" or "no" response, degree of agreement with vaccine-related statements (ranging from strongly agree to strongly disagree), questions to capture the vaccines participants plan to get for themselves and their children, and open-ended questions.
Patient-level Intervention GroupBehavioural
Participants randomized to the intervention arm will complete a computer-based questionnaire on an iPad with a preloaded app, prior to watching informational videos covering topics on maternal and childhood vaccines. The questionnaire asks about vaccine knowledge, attitudes, beliefs, and the participant's intent to receive vaccinations during pregnancy and to vaccinate their baby. The questions require "yes" or "no" responses, degree of agreement with vaccine-related statements (ranging from strongly agree to strongly disagree), and open-ended responses. After watching at least one informational video, the participant completes a questionnaire asking about the perceived usefulness of the app, degree of agreement with the vaccine information presented in the video, and ways to make the app more useful to participants.
| Study group | Role | What they receive |
|---|---|---|
| Control Site + Control Patient | Other | The obstetric practice site is randomized to be a control site and the patient is randomized to the control group. Receives: Behavioral: Control Site; Behavioral: Patient-level Control Group |
| Control Site + Intervention Patient | Experimental | The obstetric practice site is randomized to be a control site and the patient is randomized to receive the intervention. Receives: Behavioral: Control Site; Behavioral: Patient-level Intervention Group |
| Intervention Site + Control Patient | Experimental | The obstetric practice site is randomized to be an intervention site and the patient is randomized to the control group. Receives: Behavioral: Intervention Site; Behavioral: Patient-level Control Group |
| Intervention Site + Intervention Patient | Experimental | The obstetric practice site is randomized to be an intervention site and the patient is randomized to receive the intervention. Receives: Behavioral: Intervention Site; Behavioral: Patient-level Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of women receiving influenza vaccination
Whether or not the participant chose to receive the flu vaccine during pregnancy (between the baseline visit and birth of infant) will be compared between study arms
Measured: Up to 34 weeks
Number of women receiving pertussis vaccination
Whether or not the participant chose to receive the pertussis vaccine during pregnancy (between the baseline visit and birth of infant) will be compared between study arms
Measured: Up to 34 weeks
Timely childhood vaccinations
Childhood vaccination will be assessed as timely uptake of childhood vaccines by calculating average days under-vaccinated. The total number of days under-vaccinated will be divided by the number of vaccines a child should have received, according to the Advisory Committee on Immunization Practices (ACIP) schedule, to give the average number of days under-vaccinated across all recommended vaccines. This can range from 0 to 415 days in the first 20 months of life. The average number of days under-vaccinated will be modeled as a continuous variable, and the distribution of days under-vaccinated will be evaluated, in total and by vaccine where possible, to identify specific patterns of interest for follow-up.
Measured: 20 months
Secondary outcomes (3)
Changes in maternal vaccine knowledge
Maternal vaccine knowledge will be collected by the app surveys at different time periods, including before receiving the patient-level intervention, immediately after receiving the intervention, and 30 days and 18 months after the birth of the child. The survey questions assessing these outcomes will most often be measured on a Likert scale. Changes in these outcomes over time will be compared between mothers in the different study arms.
Measured: Up to 106 weeks (baseline visit until 18 months post delivery)
Changes in maternal vaccine attitudes
Maternal vaccine attitudes will be collected by the app surveys at different time periods, including before receiving the patient-level intervention, immediately after receiving the intervention, and 30 days and 18 months after the birth of the child. The survey questions assessing these outcomes will most often be measured on a Likert scale. Changes in these outcomes over time will be compared between mothers in the different study arms.
Measured: Up to 106 weeks (baseline visit until 18 months post delivery)
Changes in maternal vaccine beliefs
Maternal vaccine beliefs will be collected by the app surveys at different time periods, including before receiving the patient-level intervention, immediately after receiving the intervention, and 30 days and 18 months after the birth of the child. The survey questions assessing these outcomes will most often be measured on a Likert scale. Changes in these outcomes over time will be compared between mothers in the different study arms.
Measured: Up to 106 weeks (baseline visit until 18 months post delivery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study start12 Jun 2017
- Primary completion6 Jul 2020
- Study completion6 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for VaccinationStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 2,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Bednarczyk, Emory University
- Investigators
- Robert Bednarczyk, PhD, Principal investigator, Emory UniversityDaniel Salmon, PhD, MPH, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02898688
- Sponsor's protocol ID
- IRB00090267
- Other IDs
- 5R01AI110482-02
- Status last verified
- Aug 2020
- First submitted
- 8 Sep 2016
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dudley MZ, Omer SB, O'Leary ST, Limaye RJ, Ellingson MK, Spina CI, Brewer SE, Bednarczyk RA, Chamberlain AT, Malik F, Frew PM, Church-Balin C, Riley LE, Ault KA, Orenstein WA, Halsey NA, Salmon DA. MomsTalkShots, tailored educational app, improves vaccine attitudes: a randomized controlled trial. BMC Public Health. 2022 Nov 21;22(1):2134. doi: 10.1186/s12889-022-14498-7.
PubMed 36411403Dudley MZ, Limaye RJ, Omer SB, O'Leary ST, Ellingson MK, Spina CI, Brewer SE, Chamberlain AT, Bednarczyk RA, Malik F, Frew PM, Salmon DA. Factors associated with referring close contacts to an app with individually-tailored vaccine information. Vaccine. 2020 Mar 17;38(13):2827-2832. doi: 10.1016/j.vaccine.2020.02.019. Epub 2020 Feb 22.
PubMed 32098739
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comprehensive Pre-Natal Intervention to Increase Vaccine Coverage (P3+): Practice, Provider, Patient Level Interventions
- ClinicalTrials.gov ID
- NCT02898688
- Acronym / sponsor ID
- IRB00090267
- Conditions
- Vaccination
- Keywords
- Influenza vaccine, Pertussis vaccine, Perinatal vaccination, Infant vaccination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,200 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- 6 Jul 2020 (actual)
- Study completion
- 6 Jul 2020 (actual)
- First posted
- 13 Sep 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.
This study will address vaccine uptake both for pregnant women and for their children, through 20 months of age, to test the hypothesis that exposure to the P3+ intervention package will increase the likelihood a pregnant woman gets herself vaccinated against influenza and pertussis before delivery and get her child vaccinated on time. This study builds off of a prior intervention, developed by Emory, at the practice, provider, and patient levels (P3) to develop, implement and evaluate an enhanced intervention (P3+) to improve vaccination uptake among pregnant women, and later, their children.
Detailed description
This study will address vaccine uptake both for pregnant women and for their children, through 20 months of age, to test the hypothesis that exposure to the P3+ intervention package will increase the likelihood a pregnant woman gets herself vaccinated against influenza and pertussis before delivery and get her child vaccinated on time.
This study uses a multi-level factorial design which randomizes at both the practice and the patient level. Obstetric practices in Georgia and Colorado will be randomized to be either an intervention practice or a control practice. The women recruited in the practices and enrolled in the study will be randomly assigned to the intervention arm or the control arm.
Women randomized to the intervention arm will complete a computer-based questionnaire (administered via iPad with a preloaded study app) which asks for their basic demographic and contact information and asks questions about their vaccine knowledge, attitudes, and beliefs. Immediately following the questionnaire, participants will receive the individual level intervention (videos providing information on vaccines) on the same iPad. In order to best answer their questions and not provide information beyond the scope of what the study participants need or want, the videos provided to each participant will be selected based on responses to the survey questions. There are 6 videos: one discusses the dangers of the diseases prevented by vaccines, and the others address specific vaccine concerns (concerns include vaccine ingredients, children receiving simultaneous vaccines (multiple vaccines at one time), and the safety of receiving the tdap or flu vaccine during pregnancy). If the participant does not have any concerns, they will only see the video about dangers of vaccine preventable diseases. Participants expressing concerns in the survey will receive up to two videos addressing those concerns, based on an order of priority determined by the study researchers.
Women randomized to the control arm will also complete a computer-based questionnaire which includes their personal information and vaccine knowledge, attitudes, and beliefs questions but will then continue to receive usual prenatal care rather than view informational videos.
All enrolled women complete two follow-up surveys when their children are 30 days and 18 months of age.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control Site + Control Patient | Other | Behavioral: Control Site, Behavioral: Patient-level Control GroupThe obstetric practice site is randomized to be a control site and the patient is randomized to the control group. |
| Control Site + Intervention Patient | Experimental | Behavioral: Control Site, Behavioral: Patient-level Intervention GroupThe obstetric practice site is randomized to be a control site and the patient is randomized to receive the intervention. |
| Intervention Site + Control Patient | Experimental | Behavioral: Intervention Site, Behavioral: Patient-level Control GroupThe obstetric practice site is randomized to be an intervention site and the patient is randomized to the control group. |
| Intervention Site + Intervention Patient | Experimental | Behavioral: Intervention Site, Behavioral: Patient-level Intervention GroupThe obstetric practice site is randomized to be an intervention site and the patient is randomized to receive the intervention. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Have not previously participated in this study
- Currently pregnant
- Up to 26 weeks gestational age
- Able to understand and communicate in English
Key exclusion criteria (1 listed)
- Have received pertussis vaccine during the current pregnancy
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 |
|---|---|---|
| Control SiteAlso: Practice/provider-Level ControlControl sites will continue with their standard practice regarding discussing vaccines with their patients. | Behavioural | Control Site + Control Patient, Control Site + Intervention Patient |
| Intervention SiteAlso: Practice/provider-Level InterventionIntervention Sites will each assign a Vaccine Champion and will have Assessment, Feedback, Incentives, and eXchange (AFIX) visits. AFIX is a quality improvement program to raise immunization coverage levels, reduce missed opportunities to vaccinate, and improve standards of practices at the provider level. A Continuing Medical Education (CME) module will be given to all providers, covering the recommended maternal vaccinations and how to talk to patients about vaccines. Intervention sites will have access to written materials covering all recommended maternal and infant vaccinations, the diseases they prevent, potential adverse reactions and common patient questions with talking points and references for each topic. | Behavioural | Intervention Site + Control Patient, Intervention Site + Intervention Patient |
| Patient-level Control GroupParticipants randomized the control arm will complete a computer-based questionnaire, on an iPad with a preloaded app. The questionnaire asks about vaccine knowledge, attitudes, and beliefs and the participant's intent to receive vaccinations during pregnancy and to vaccinate their baby. The questionnaire includes questions requiring a "yes" or "no" response, degree of agreement with vaccine-related statements (ranging from strongly agree to strongly disagree), questions to capture the vaccines participants plan to get for themselves and their children, and open-ended questions. | Behavioural | Control Site + Control Patient, Intervention Site + Control Patient |
| Patient-level Intervention GroupParticipants randomized to the intervention arm will complete a computer-based questionnaire on an iPad with a preloaded app, prior to watching informational videos covering topics on maternal and childhood vaccines. The questionnaire asks about vaccine knowledge, attitudes, beliefs, and the participant's intent to receive vaccinations during pregnancy and to vaccinate their baby. The questions require "yes" or "no" responses, degree of agreement with vaccine-related statements (ranging from strongly agree to strongly disagree), and open-ended responses. After watching at least one informational video, the participant completes a questionnaire asking about the perceived usefulness of the app, degree of agreement with the vaccine information presented in the video, and ways to make the app more useful to participants. | Behavioural | Control Site + Intervention Patient, Intervention Site + Intervention Patient |
Primary outcome
Number of women receiving influenza vaccination
Time frame: Up to 34 weeks
Whether or not the participant chose to receive the flu vaccine during pregnancy (between the baseline visit and birth of infant) will be compared between study arms
Number of women receiving pertussis vaccination
Time frame: Up to 34 weeks
Whether or not the participant chose to receive the pertussis vaccine during pregnancy (between the baseline visit and birth of infant) will be compared between study arms
Timely childhood vaccinations
Time frame: 20 months
Childhood vaccination will be assessed as timely uptake of childhood vaccines by calculating average days under-vaccinated. The total number of days under-vaccinated will be divided by the number of vaccines a child should have received, according to the Advisory Committee on Immunization Practices (ACIP) schedule, to give the average number of days under-vaccinated across all recommended vaccines. This can range from 0 to 415 days in the first 20 months of life. The average number of days under-vaccinated will be modeled as a continuous variable, and the distribution of days under-vaccinated will be evaluated, in total and by vaccine where possible, to identify specific patterns of interest for follow-up.
3 secondary outcomes
Changes in maternal vaccine knowledge
Time frame: Up to 106 weeks (baseline visit until 18 months post delivery)
Changes in maternal vaccine attitudes
Time frame: Up to 106 weeks (baseline visit until 18 months post delivery)
Changes in maternal vaccine beliefs
Time frame: Up to 106 weeks (baseline visit until 18 months post delivery)
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 5 Aug 2020.
- Derived from this study: PubMed 36411403Dudley MZ, Omer SB, O'Leary ST, Limaye RJ, Ellingson MK, Spina CI, Brewer SE, Bednarczyk RA, Chamberlain AT, Malik F, Frew PM, Church-Balin C, Riley LE, Ault KA, Orenstein WA, Halsey NA, Salmon DA. MomsTalkShots, tailored educational app, improves vaccine attitudes: a randomized controlled trial. BMC Public Health. 2022 Nov 21;22(1):2134. doi: 10.1186/s12889-022-14498-7.
- Derived from this study: PubMed 32098739Dudley MZ, Limaye RJ, Omer SB, O'Leary ST, Ellingson MK, Spina CI, Brewer SE, Chamberlain AT, Bednarczyk RA, Malik F, Frew PM, Salmon DA. Factors associated with referring close contacts to an app with individually-tailored vaccine information. Vaccine. 2020 Mar 17;38(13):2827-2832. doi: 10.1016/j.vaccine.2020.02.019. Epub 2020 Feb 22.
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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.
Robert Bednarczyk, PhD principal investigator
Emory University
Daniel Salmon, PhD, MPH principal investigator
Johns Hopkins Bloomberg School of Public Health
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Site and Patient-level Intervention Group in people with Vaccination, run by Emory University at 23 sites 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 4 inclusion and 1 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 5 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites 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.
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?
Number of women receiving influenza vaccination (time frame: Up to 34 weeks). 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?
On the ClinicalTrials.gov record for NCT02898688, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2020.