PertussisNCT00258882

Descriptive, Post-marketing, Passive Surveillance Safety Study of ADACEL™ Vaccine

An observational study of Pertussis, run by Sanofi Pasteur, a Sanofi Company at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To further characterize the vaccine safety profile and to identify any signals of potentially vaccine-related adverse events (AEs) not detected during pre-licensure studies. Read more about this study

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Pertussis
What is being tested?: Tetanus Toxoid, acellular pertussis, diphtheria toxoid
Type of treatment: Injection or infusion
How many people: 327,293 participants
Where: 3 sitesUnited States
Study dates: Jan 2006to Dec 2012
Phase: Observational
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 Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Study population: Passive surveillance by review of Kaiser Permanente Medical Care Program (KPMCP) computerized records and state mortality tapes

Who may be able to join

Receipt of ADACEL vaccine during the study period

Who cannot join

None

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Study site
Aurora, Colorado
Study site
Oakland, California
Study site
Portland, Oregon

Other trials in United States

About this study

Official title: Post-licensure Safety Surveillance Study of Routine Use of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Adacel®)

To further characterize the vaccine safety profile and to identify any signals of potentially vaccine-related adverse events (AEs) not detected during pre-licensure studies.

Read the detailed description

Surveillance using a healthcare organization with large comprehensive medical encounter databases will be used in this study to identify any risks or uncommon events associated with use of the recently licensed Adacel vaccine that may occur in routine clinical usage in a large population.

No investigational vaccines will be administered in this study. Participants will be included in the study on the basis of their having received Adacel vaccine as part of routine care.

Conditions: Pertussis
Being tested: Tetanus Toxoid, acellular pertussis, diphtheria toxoid
Keywords: Tetanus Toxoid,, acellular pertussis,, diphtheria toxoid
Medical subject headings: Whooping Cough, Tetanus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tetanus Toxoid, acellular pertussis, diphtheria toxoidBiological
Also called Adacel®
0.5 mL, Intramuscular

What is being measured

The primary outcome is the main question the study is designed to answer.

Twenty One Pre-specified Outcomes of Interest as Obtained From International Coding of Diseases (ICD-9) Codes Captured After Adacel Vaccination in Clinical Database
The twenty one pre-specified outcomes of special interest screened for in this study included: Arthritis, Arthralgia, or Arthropathy; Bell's Palsy; Diabetes; Encephalitis; Encephalopathy; Febrile Illness; Guillain-Barré; Hemolytic Anemia; Hypersensitivity; Idiopathic Thrombocytopenic Purpura (ITP); Lupus; Mixed Connective Tissue Disease; Multiple Sclerosis; Neuralgia; Neuritis; Neuropathy; Rheumatoid Arthritis; Scleroderma; Seizure; Severe Local Reaction; Transverse Myelitis.
Comparison of events rates was performed using the risk-interval cohort design. In this design, the combined experience of individuals receiving Adacel vaccine served as their own control for evaluation of pre-specified outcomes of interest. Rates of events occurring during Days 0 to X (where X = 7, 14, 30, and 60) following vaccination were compared to rates of events occurring in the same individuals during Days 61 to 120 following vaccination.
Measured: Days 0 to 60 and Day 61 to 120 following vaccination
Twenty One Pre-specified Outcomes of Interest (ICD-9 Codes) Captured After Adacel Vaccination in Clinic Database
The twenty one pre-specified outcomes of special interest screened for in this study included: Arthritis, Arthralgia, or Arthropathy; Bell's Palsy; Diabetes; Encephalitis; Encephalopathy; Febrile Illness; Guillain-Barré; Hemolytic Anemia; Hypersensitivity; ITP; Lupus; Mixed Connective Tissue Disease; Multiple Sclerosis; Neuralgia; Neuritis; Neuropathy; Rheumatoid Arthritis; Scleroderma; Seizure; Severe Local Reaction; Transverse Myelitis.
Comparison of events rates was performed using the historic cohort design in which screening for possible new-onset chronic illnesses during the first 6 months following vaccination was performed. For each age-subgroup event, rates during the 6 months following vaccination among persons receiving Adacel vaccine were compared to event rates during the 6 months following vaccination among persons in the same age subgroup who received Td vaccine, but no live virus vaccine, during the year prior to initiation of this study.
Measured: Days 0 up to 180 following vaccination
All Diagnoses (Coded as ICD-9 Codes) Occurring During Specific Periods After Vaccination in All Adacel Exposed Individuals in Emergency Department and Hospital Databases.
Surveillance for acute onset outcomes occurring shortly (days to weeks) after vaccination was performed using the risk-interval cohort design. In this design, the combined experience of individuals receiving Adacel vaccine served as their own control for evaluation of acute events. Rates of events occurring during Days 0 to X (where X = 7, 14, 30, and 60) following vaccination were compared to rates of events occurring in the same individuals during Days 61 to 120 following vaccination
Measured: Days 0 to 60 and Day 61 to 120 following vaccination
All Diagnoses (Coded as ICD-9 Codes) Occurring During 6 Months After Vaccination in All Adacel Exposed Individuals in Emergency Department and Hospital Databases.
Comparison of events rates was performed using the historic cohort design in which screening for possible new-onset chronic illnesses during the first 6 months following vaccination was performed. For each age-subgroup event, rates during the 6 months following vaccination among persons receiving Adacel vaccine were compared to event rates during the 6 months following vaccination among persons in the same age subgroup who received Td vaccine, but no live virus vaccine, during the year prior to initiation of this study.
Measured: Days 0 to 180 following vaccination
Summary of Maternal Outcomes in Pregnant Adacel Recipients and Pregnant Non-Adacel Recipient Controls
Pregnancies were identified by positive pregnancy tests or prenatal visits within 9 months prior to vaccination with no record of pre-vaccination delivery or abortion, or by prenatal visits, therapeutic abortions, or deliveries within 10 months after vaccination. For all such pregnancies, further review (including chart review, provider and vaccinee interviews, or other appropriate steps) was conducted to identify those for whom it could not be excluded that the individual was pregnant at the time of vaccination or within 28 days thereafter. Such pregnancies were reported by Kaiser Permanente Vaccine Study Center to the Adacel Pregnancy Registry. Maternal and fetal outcomes (up to 1 month of life) were enumerated. For each pregnant Adacel vaccine subjects, 3 age-matched non-Adacel vaccinated controls (± 1 year) that had a first positive pregnancy test during the same month (± 1 month). Rates of events of maternal and fetal outcomes were compared between the 2 groups.
Measured: Pregnancy to Delivery, up to 9 months
Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls.
Pregnancies were identified by positive pregnancy tests or prenatal visits within 9 months prior to vaccination with no record of pre-vaccination delivery or abortion, or by prenatal visits, therapeutic abortions, or deliveries within 10 months after vaccination. For all such pregnancies, further review (including chart review, provider and vaccinee interviews, or other appropriate steps) was conducted to identify those for whom it could not be excluded that the individual was pregnant at the time of vaccination or within 28 days thereafter. Such pregnancies were reported by Kaiser Permanente Vaccine Study Center to the Adacel Pregnancy Registry. Maternal and fetal outcomes (up to 1 month of life) were enumerated. For each pregnant Adacel vaccine subjects, 3 age-matched non-Adacel vaccinated controls (± 1 year) that had a first positive pregnancy test during the same month (± 1 month). Rates of events of maternal and fetal outcomes were compared between the 2 groups.
Measured: Pregnancy to Delivery, up to 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2006Dec 2012

First posted28 Nov 2005 (estimated)
Study startJan 2006
Primary completionJul 2011
Study completionDec 2012

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 PertussisStudies of the same condition, open and under way.
More trials run by Sanofi Pasteur, a Sanofi CompanyThe 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: Observational
Observational model: Cohort
Time perspective: Other
Enrolment: 327,293 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00258882
Sponsor's protocol ID: TD512
Status last verified: Jun 2018
First submitted: 24 Nov 2005
Last updated: 17 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Baxter R, Hansen J, Timbol J, Pool V, Greenberg DP, Johnson DR, Decker MD. Post-licensure safety surveillance study of routine use of tetanus toxoid, reduced diphtheria toxoid and 5-component acellular pertussis vaccine. Hum Vaccin Immunother. 2016 Nov;12(11):2742-2748. doi: 10.1080/21645515.2016.1201622. Epub 2016 Jul 7.
PubMed 27388557

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
A Phase II Clinical Trial of Absorbed Acellular Pertussis (Two-Component) Diphtheria-Tetanus Combined Vaccine (For Adults and Adolescents)
Pertussis (Whooping Cough), Diphtheria
RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
RecruitingPhase 4
Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy
RSV, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination
Not yet recruitingObservational study
Assessment of the Acceptability of, and Factors Associated With, Recommended Vaccinations During Pregnancy in Maternity Units in the Ile-de-France Region
Vaccination Coverage Among Pregnant Women
Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization

All Pertussis trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post-licensure Safety Surveillance Study of Routine Use of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Adacel®)
ClinicalTrials.gov ID: NCT00258882
Acronym / sponsor ID: TD512
Conditions: Pertussis
Keywords: Tetanus Toxoid,, acellular pertussis,, diphtheria toxoid
Study type: Observational
Recruitment status: Completed
Enrolment: 327,293 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: Jan 2006
Primary completion: Jul 2011 (actual)
Study completion: Dec 2012 (actual)
First posted: 28 Nov 2005 (estimated)
Results: Posted 13 Apr 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To further characterize the vaccine safety profile and to identify any signals of potentially vaccine-related adverse events (AEs) not detected during pre-licensure studies.

Detailed description

No investigational vaccines will be administered in this study. Participants will be included in the study on the basis of their having received Adacel vaccine as part of routine care.

Study design

Observational model: Cohort
Time perspective: Other

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult
Study population: Passive surveillance by review of Kaiser Permanente Medical Care Program (KPMCP) computerized records and state mortality tapes

Key inclusion criteria (1 listed)

Receipt of ADACEL vaccine during the study period

Key exclusion criteria (1 listed)

None

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
Tetanus Toxoid, acellular pertussis, diphtheria toxoidAlso: Adacel®0.5 mL, Intramuscular	Biological	–

Primary outcome

Twenty One Pre-specified Outcomes of Interest as Obtained From International Coding of Diseases (ICD-9) Codes Captured After Adacel Vaccination in Clinical Database
Time frame: Days 0 to 60 and Day 61 to 120 following vaccination
The twenty one pre-specified outcomes of special interest screened for in this study included: Arthritis, Arthralgia, or Arthropathy; Bell's Palsy; Diabetes; Encephalitis; Encephalopathy; Febrile Illness; Guillain-Barré; Hemolytic Anemia; Hypersensitivity; Idiopathic Thrombocytopenic Purpura (ITP); Lupus; Mixed Connective Tissue Disease; Multiple Sclerosis; Neuralgia; Neuritis; Neuropathy; Rheumatoid Arthritis; Scleroderma; Seizure; Severe Local Reaction; Transverse Myelitis. Comparison of events rates was performed using the risk-interval cohort design. In this design, the combined experience of individuals receiving Adacel vaccine served as their own control for evaluation of pre-specified outcomes of interest. Rates of events occurring during Days 0 to X (where X = 7, 14, 30, and 60) following vaccination were compared to rates of events occurring in the same individuals during Days 61 to 120 following vaccination.
Twenty One Pre-specified Outcomes of Interest (ICD-9 Codes) Captured After Adacel Vaccination in Clinic Database
Time frame: Days 0 up to 180 following vaccination
The twenty one pre-specified outcomes of special interest screened for in this study included: Arthritis, Arthralgia, or Arthropathy; Bell's Palsy; Diabetes; Encephalitis; Encephalopathy; Febrile Illness; Guillain-Barré; Hemolytic Anemia; Hypersensitivity; ITP; Lupus; Mixed Connective Tissue Disease; Multiple Sclerosis; Neuralgia; Neuritis; Neuropathy; Rheumatoid Arthritis; Scleroderma; Seizure; Severe Local Reaction; Transverse Myelitis. Comparison of events rates was performed using the historic cohort design in which screening for possible new-onset chronic illnesses during the first 6 months following vaccination was performed. For each age-subgroup event, rates during the 6 months following vaccination among persons receiving Adacel vaccine were compared to event rates during the 6 months following vaccination among persons in the same age subgroup who received Td vaccine, but no live virus vaccine, during the year prior to initiation of this study.
All Diagnoses (Coded as ICD-9 Codes) Occurring During Specific Periods After Vaccination in All Adacel Exposed Individuals in Emergency Department and Hospital Databases.
Time frame: Days 0 to 60 and Day 61 to 120 following vaccination
Surveillance for acute onset outcomes occurring shortly (days to weeks) after vaccination was performed using the risk-interval cohort design. In this design, the combined experience of individuals receiving Adacel vaccine served as their own control for evaluation of acute events. Rates of events occurring during Days 0 to X (where X = 7, 14, 30, and 60) following vaccination were compared to rates of events occurring in the same individuals during Days 61 to 120 following vaccination
All Diagnoses (Coded as ICD-9 Codes) Occurring During 6 Months After Vaccination in All Adacel Exposed Individuals in Emergency Department and Hospital Databases.
Time frame: Days 0 to 180 following vaccination
Comparison of events rates was performed using the historic cohort design in which screening for possible new-onset chronic illnesses during the first 6 months following vaccination was performed. For each age-subgroup event, rates during the 6 months following vaccination among persons receiving Adacel vaccine were compared to event rates during the 6 months following vaccination among persons in the same age subgroup who received Td vaccine, but no live virus vaccine, during the year prior to initiation of this study.
Summary of Maternal Outcomes in Pregnant Adacel Recipients and Pregnant Non-Adacel Recipient Controls
Time frame: Pregnancy to Delivery, up to 9 months
Pregnancies were identified by positive pregnancy tests or prenatal visits within 9 months prior to vaccination with no record of pre-vaccination delivery or abortion, or by prenatal visits, therapeutic abortions, or deliveries within 10 months after vaccination. For all such pregnancies, further review (including chart review, provider and vaccinee interviews, or other appropriate steps) was conducted to identify those for whom it could not be excluded that the individual was pregnant at the time of vaccination or within 28 days thereafter. Such pregnancies were reported by Kaiser Permanente Vaccine Study Center to the Adacel Pregnancy Registry. Maternal and fetal outcomes (up to 1 month of life) were enumerated. For each pregnant Adacel vaccine subjects, 3 age-matched non-Adacel vaccinated controls (± 1 year) that had a first positive pregnancy test during the same month (± 1 month). Rates of events of maternal and fetal outcomes were compared between the 2 groups.
Summary of Fetal Outcomes in Infants Born to Adacel Exposed Pregnant Women and Infants Born to Non-Adacel Exposed Pregnant Controls.
Time frame: Pregnancy to Delivery, up to 9 months
Pregnancies were identified by positive pregnancy tests or prenatal visits within 9 months prior to vaccination with no record of pre-vaccination delivery or abortion, or by prenatal visits, therapeutic abortions, or deliveries within 10 months after vaccination. For all such pregnancies, further review (including chart review, provider and vaccinee interviews, or other appropriate steps) was conducted to identify those for whom it could not be excluded that the individual was pregnant at the time of vaccination or within 28 days thereafter. Such pregnancies were reported by Kaiser Permanente Vaccine Study Center to the Adacel Pregnancy Registry. Maternal and fetal outcomes (up to 1 month of life) were enumerated. For each pregnant Adacel vaccine subjects, 3 age-matched non-Adacel vaccinated controls (± 1 year) that had a first positive pregnancy test during the same month (± 1 month). Rates of events of maternal and fetal outcomes were compared between the 2 groups.

Results and safety

Results posted to the registry on 13 Apr 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Adacel Vaccine Group	124,139	124,139
Control Groups	203,154	203,154

Primary outcome: Twenty One Pre-specified Outcomes of Interest as Obtained From International Coding of Diseases (ICD-9) Codes Captured After Adacel Vaccination in Clinical Database

Time frame: Days 0 to 60 and Day 61 to 120 following vaccination. Number. Unit: Events Per 1000 Person-months

Measure	Adacel Vaccine Group n = 124139	Control Groups n = 0
Value	0	–

Population analysed: Individuals receiving Adacel vaccine served as their own control for evaluation of acute events.

Primary outcome: Twenty One Pre-specified Outcomes of Interest (ICD-9 Codes) Captured After Adacel Vaccination in Clinic Database

Time frame: Days 0 up to 180 following vaccination. Number. Unit: Events Per 1000 Person-months

Measure	Adacel Vaccine Group n = 124139	Control Groups n = 203154
Value	0	0

Population analysed: Individuals receiving Adacel vaccine served as their own control for evaluation of acute events.

Primary outcome: All Diagnoses (Coded as ICD-9 Codes) Occurring During Specific Periods After Vaccination in All Adacel Exposed Individuals in Emergency Department and Hospital Databases.

Time frame: Days 0 to 60 and Day 61 to 120 following vaccination. Number. Unit: Events Per 1000 Person-months

Measure	Adacel Vaccine Group n = 124139	Control Groups n = 0
Value	0	–

Population analysed: Individuals receiving Adacel vaccine served as their own control for evaluation of acute events.

Primary outcome: All Diagnoses (Coded as ICD-9 Codes) Occurring During 6 Months After Vaccination in All Adacel Exposed Individuals in Emergency Department and Hospital Databases.

Time frame: Days 0 to 180 following vaccination. Number. Unit: Events per 1000 Person-months

Measure	Adacel Vaccine Group n = 124139	Control Groups n = 0
Value	0	–

Population analysed: Individuals receiving Adacel vaccine served as their own control for evaluation of acute events.

Adverse events

Time frame: Adverse events data surveillance period were only in Adacel vaccine recipients from the day of vaccination up to 6 months post-vaccination from the Outpatient, Emergency Room and Hospital databases.. Other adverse events reported at 5.0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adacel Vaccine Group	4 of 124,139 (0%)	0 of 124,139 (0%)	Not reported

Limitations and caveats (from the sponsor): As a result of screening using The Risk Interval and The Historic Cohort methods incident rates for 1030 outcomes were flagged as elevated. In post-hoc manual review no safety signals were identified. Details highlighted in the manuscript.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27388557Baxter R, Hansen J, Timbol J, Pool V, Greenberg DP, Johnson DR, Decker MD. Post-licensure safety surveillance study of routine use of tetanus toxoid, reduced diphtheria toxoid and 5-component acellular pertussis vaccine. Hum Vaccin Immunother. 2016 Nov;12(11):2742-2748. doi: 10.1080/21645515.2016.1201622. Epub 2016 Jul 7.

Related trials for Pertussis

RecruitingPhase 2
A Phase II Clinical Trial of Absorbed Acellular Pertussis (Two-Component) Diphtheria-Tetanus Combined Vaccine (For Adults and Adolescents)
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RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
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RecruitingPhase 4
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Not yet recruitingPhase 1/2
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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.

Medical Director study director

Sanofi Pasteur Inc.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Pertussis, run by Sanofi Pasteur, a Sanofi Company at 3 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 1 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 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

Yes. Results are posted in the registry (first posted 13 Apr 2016). 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?

Twenty One Pre-specified Outcomes of Interest as Obtained From International Coding of Diseases (ICD-9) Codes Captured After Adacel Vaccination in Clinical Database (time frame: Days 0 to 60 and Day 61 to 120 following vaccination). The study lists 6 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 NCT00258882, 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 17 Jul 2018.