Measles Antibody SeroconversionPhase 4NCT01700621
Coadministration of Measles-rubella and Rotavirus Vaccines
A Phase 4 study testing Rotarix vaccine and measles-rubella vaccine in people with Measles Antibody Seroconversion and Rubella Antibody Seroconversion, run by PATH at 1 site in Bangladesh.
Trial summary
The investigators aim to establish the non-inferiority of concomitant administration of measles-rubella and rotavirus vaccines to measles-rubella vaccine given alone in terms of measles seroconversion rates. Read more about this study
- Who is it for?
- Ages 9 to 11 monthsHealthy volunteers can take part
- Conditions the study is for
- Measles Antibody Seroconversion, Rubella Antibody Seroconversion, Rotavirus Geometric Mean Titer (GMT)
- What is being tested?
- Rotarix vaccine and measles-rubella vaccine
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 482 participants
- Where
- 1 siteBangladesh
- Study dates
- Jan 2013to Sep 2013
- Phase
- Phase 4
- 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 9 to 11 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child 9 months of age eligible for measles-rubella vaccination
- documented evidence of a primary rotavirus vaccine series with first dose between 6 and 10 weeks of age and second dose at least 4 weeks after first dose
- healthy infants free of chronic or serious medical condition as determined by history and physical examination at time of study enrollment
- parents/guardians of each participant are able to understand and follow study procedures and agree to participate in study by providing signed informed consent
Who cannot join
- hypersensitivity to any component of measles-rubella or Rotarix vaccine which would preclude administration of the vaccine
- history of intussusception, intestinal malformations, or abdominal surgery
- known history of measles and/or rubella disease
- history of previous receipt of measles and/or rubella vaccine
- use of any immunosuppressive drugs or immunoglobulin and/or blood products since birth or anticipated during study period
- current enrolment in any other intervention trial or use of any investigational drug or vaccine throughout the study period
Show all 9Show fewer
- any participant who reports planning to leave the study area before the completion of the study
- acute diarrhea (defined as ≥3 loose stools within a 24-hour period) or vomiting (defined as projectile vomiting or any vomiting at the discretion of the clinician) at the time of enrollment or within the last 24 hours
- acute febrile illness (defined as a temperature of ≥38°C) at the time of enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-interference and Safety of Concomitant Administration of Measles-rubella and Rotavirus Vaccines at 9 Months of Age in Rural Bangladesh
The investigators aim to establish the non-inferiority of concomitant administration of measles-rubella and rotavirus vaccines to measles-rubella vaccine given alone in terms of measles seroconversion rates. The primary study hypothesis is the measles seroconversion rate as defined by the percentage of children seroconverting to measles with a measles serum antibody concentration of >=1:120 at 8 weeks post vaccination after the concomitant administration of measles-rubella and rotavirus vaccines is non-inferior to that obtained when measles-rubella vaccine is given alone in children 9 months of age who have received a primary rotavirus vaccine series with the first dose between 6 and 10 weeks and the second at least 4 weeks later and are seronegative for measles antibody in the pre-vaccination sample.
- Conditions
- Measles Antibody Seroconversion, Rubella Antibody Seroconversion, Rotavirus Geometric Mean Titer (GMT), Rotavirus Immunoglobulin A (IgA) Seropositivity
- Being tested
- Rotarix vaccine, measles-rubella vaccine
- Keywords
- rotavirus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotarix vaccineBiological
Also called rotavirus vaccine
one 1.0 ml dose of oral rotavirus vaccine at 9 months of age
measles-rubella vaccineBiological
Also called Measles-Rubella Virus Vaccine Live US Pharmacopeia (USP)
one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine
| Study group | Role | What they receive |
|---|---|---|
| measles-rubella and rotavirus vaccines | Experimental | receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age Receives: Biological: Rotarix vaccine; Biological: measles-rubella vaccine |
| measles-rubella vaccine | Active comparator | receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age Receives: Biological: measles-rubella vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage/Number of Subjects With Seroprotection for Measles Virus Serum Neutralization Antibodies
Detected by plaque reduction neutralization test (PRNT).
Seroprotection defined as measles serum antibody concentration >=1:120 8 weeks post vaccination. Assays were standardized using WHO Second International Standard for measles antibody containing 5000 mIU/ml, which enables the 50% neutralizing antibody end-point dose (titer, ND50) of test samples to be transformed to antibody concentrations in terms of mIU/ml. The analytical cut-off value in this assay was ND50 < 1/8; this was the lowest dilution at which sera were tested.
Measured: 8 weeks post vaccination
Percentage/Number of Subjects With Seroprotection for Anti-measles Virus Immunoglobulin G (IgG)
Used commercially available indirect enzyme-linked IgG immunoassays (EIAs; Wampole Laboratories, Princeton, New Jersey). An index standard ratio (ISR) of ≥1.10 on both runs of the respective assay was considered evidence of seropositivity for measles virus. All measles virus and rubella virus assays were performed at the National Measles and Rubella Reference Laboratories, Measles, Mumps, Rubella, and Herpesviruses Branch, Division of Viral Diseases, Centers for Disease Control and Prevention (Atlanta, Georgia).
Measured: 8 weeks post vaccination
Secondary outcomes (12)
Percentage/Number of Subjects With Seroconversion for Anti-rubella Virus Immunoglobulin G (IgG)
Used commercially available indirect enzyme-linked IgG immunoassays (EIAs; Wampole Laboratories, Princeton, New Jersey). An index standard ratio (ISR) of ≥1.10 on both runs of the respective assay was considered evidence of seropositivity for rubella virus. An ISR of at least 1.10 represents 10 IU/mL of rubella virus antibody, consistent with a protective level.All measles virus and rubella virus assays were performed at the National Measles and Rubella Reference Laboratories, Measles, Mumps, Rubella, and Herpesviruses Branch, Division of Viral Diseases, Centers for Disease Control and Prevention (Atlanta, Georgia).
Measured: 8 weeks post vaccination
Geometric Mean Concentration (GMC) for Anti-rubella Virus Immunoglobulin G (IgG)
Used commercially available indirect enzyme-linked IgG immunoassays (EIAs; Wampole Laboratories, Princeton, New Jersey). An index standard ratio (ISR) of ≥1.10 on both runs of the respective assay was considered evidence of seropositivity for rubella virus. An ISR of at least 1.10 represents 10 IU/mL of rubella virus antibody, consistent with a protective level.All measles virus and rubella virus assays were performed at the National Measles and Rubella Reference Laboratories, Measles, Mumps, Rubella, and Herpesviruses Branch, Division of Viral Diseases, Centers for Disease Control and Prevention (Atlanta, Georgia).
Measured: 8 weeks post vaccination
Percentage/Number of Subjects Seropositive for Anti-rotavirus Immunoglobulin A (IgA)
Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. A subject was considered seropositive if the IgA or IgG rotavirus antibody concentration was ≥20 U/mL.
Measured: Visit 1 (pre-vaccination) and 8 weeks post vaccination
Geometric Mean Titer (GMT) of Anti-rotavirus Immunoglobulin A (IgA)
Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. Rotavirus IgA and IgG values of <20 U/mL are converted to 10 U/mL for calculation purposes.
Measured: Visit 1 (pre-vaccination) and 8 weeks post vaccination
Percentage/Number of Subjects Seropositive for Anti-rotavirus Immunoglobulin G (IgG)
Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. A subject was considered seropositive if the IgA or IgG rotavirus antibody concentration was ≥20 U/mL.
Measured: Visit 1 (pre-vaccination) and 8 weeks post vaccination
Geometric Mean Titer (GMT) of Anti-rotavirus Immunoglobulin G (IgG)
Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. Rotavirus IgA and IgG values of <20 U/mL are converted to 10 U/mL for calculation purposes.
Measured: Visit 1 (pre-vaccination) and 8 weeks post vaccination
Percentage/Number of Subjects With Seroconversion for Anti-rotavirus Immunoglobulin A (IgA)
Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. A subject was considered seropositive if the IgA or IgG rotavirus antibody concentration was ≥20 U/mL.
Measured: 8 weeks post vaccination
Percentage/Number of Subjects With Seroconversion for Anti-rotavirus Immunoglobulin G (IgG)
Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. A subject was considered seropositive if the IgA or IgG rotavirus antibody concentration was ≥20 U/mL.
Measured: 8 weeks post vaccination
Number/Percentage of Subjects Experiencing Immediate Post-vaccination Reactions Following Administration of Vaccine
Immediate reactogenicity was defined as local or systemic reactions occurring directly and up to 30 minutes after vaccine receipt, with an emphasis on allergic reactions.
Measured: 30 minutes post-vaccination
Number/Percentage of Subjects Experiencing Solicited Adverse Events
Solicited non-serious adverse events were collected based on recall at study visits 2 (Day 4) through 5 (Day 14) following administration of Rotarix® vaccine. They included diarrhea, fever, vomiting, loss of appetite, irritability, and intussusception. Adverse events were graded for severity and relationship to vaccine.
Measured: 14 days post-vaccination
Number/Percentage of Subjects Experiencing Unsolicited Non-serious Adverse Events
Solicited non-serious adverse events were collected based on recall at study visits 2 (Day 4) through 5 (Day 14) following administration of Rotarix® vaccine. Adverse events were graded for severity and relationship to vaccine.
Measured: 14 days post-vaccination
Number/Percentage of Subjects Experiencing Serious Adverse Events
An adverse event (AE) or suspected AE was considered "serious" if it resulted in any of the following outcomes:
- Death
- A life-threatening AE (the term "life-threatening" in the definition of "serious" refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe)
- Inpatient hospitalization or prolongation of existing hospitalization
- A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions
Important medical events that may not result in death, be life threatening, or require hospitalization would have been considered severe adverse events when, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed in this definition.
Measured: 2 months after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study startJan 2013
- Primary completionSep 2013
- Study completionSep 2013
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 Measles Antibody SeroconversionStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 482 participants (actual)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- K Zaman, PhD, MPH, Principal investigator, International Centre for Diarrhoeal Disease Research, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01700621
- Sponsor's protocol ID
- HS677
- Status last verified
- Feb 2019
- First submitted
- 2 Oct 2012
- Last updated
- 13 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Zaman K, Fleming JA, Victor JC, Yunus M, Bari TI, Azim T, Rahman M, Mowla SM, Bellini WJ, McNeal M, Icenogle JP, Lopman B, Parashar U, Cortese MM, Steele AD, Neuzil KM. Noninterference of Rotavirus Vaccine With Measles-Rubella Vaccine at 9 Months of Age and Improvements in Antirotavirus Immunity: A Randomized Trial. J Infect Dis. 2016 Jun 1;213(11):1686-93. doi: 10.1093/infdis/jiw024. Epub 2016 Jan 27.
PubMed 26823338
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interference and Safety of Concomitant Administration of Measles-rubella and Rotavirus Vaccines at 9 Months of Age in Rural Bangladesh
- ClinicalTrials.gov ID
- NCT01700621
- Acronym / sponsor ID
- HS677
- Conditions
- Measles Antibody Seroconversion, Rubella Antibody Seroconversion, Rotavirus Geometric Mean Titer (GMT), Rotavirus Immunoglobulin A (IgA) Seropositivity
- Keywords
- rotavirus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 482 participants (actual)
- Lead sponsor
- PATHUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 4 Oct 2012 (estimated)
- Results
- Posted 18 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aim to establish the non-inferiority of concomitant administration of measles-rubella and rotavirus vaccines to measles-rubella vaccine given alone in terms of measles seroconversion rates. The primary study hypothesis is the measles seroconversion rate as defined by the percentage of children seroconverting to measles with a measles serum antibody concentration of >=1:120 at 8 weeks post vaccination after the concomitant administration of measles-rubella and rotavirus vaccines is non-inferior to that obtained when measles-rubella vaccine is given alone in children 9 months of age who have received a primary rotavirus vaccine series with the first dose between 6 and 10 weeks and the second at least 4 weeks later and are seronegative for measles antibody in the pre-vaccination sample.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| measles-rubella and rotavirus vaccines | Experimental | Biological: Rotarix vaccine, Biological: measles-rubella vaccinereceive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age |
| measles-rubella vaccine | Active comparator | Biological: measles-rubella vaccinereceive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age |
Who may qualify
- Ages
- 9 to 11 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Child 9 months of age eligible for measles-rubella vaccination
- documented evidence of a primary rotavirus vaccine series with first dose between 6 and 10 weeks of age and second dose at least 4 weeks after first dose
- healthy infants free of chronic or serious medical condition as determined by history and physical examination at time of study enrollment
- parents/guardians of each participant are able to understand and follow study procedures and agree to participate in study by providing signed informed consent
Key exclusion criteria (9 listed)
- hypersensitivity to any component of measles-rubella or Rotarix vaccine which would preclude administration of the vaccine
- history of intussusception, intestinal malformations, or abdominal surgery
- known history of measles and/or rubella disease
- history of previous receipt of measles and/or rubella vaccine
- use of any immunosuppressive drugs or immunoglobulin and/or blood products since birth or anticipated during study period
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 |
|---|---|---|
| Rotarix vaccineAlso: rotavirus vaccineone 1.0 ml dose of oral rotavirus vaccine at 9 months of age | Biological | measles-rubella and rotavirus vaccines |
| measles-rubella vaccineAlso: Measles-Rubella Virus Vaccine Live US Pharmacopeia (USP)one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine | Biological | measles-rubella and rotavirus vaccines, measles-rubella vaccine |
Primary outcome
Percentage/Number of Subjects With Seroprotection for Measles Virus Serum Neutralization Antibodies
Time frame: 8 weeks post vaccination
Detected by plaque reduction neutralization test (PRNT). Seroprotection defined as measles serum antibody concentration >=1:120 8 weeks post vaccination. Assays were standardized using WHO Second International Standard for measles antibody containing 5000 mIU/ml, which enables the 50% neutralizing antibody end-point dose (titer, ND50) of test samples to be transformed to antibody concentrations in terms of mIU/ml. The analytical cut-off value in this assay was ND50 < 1/8; this was the lowest dilution at which sera were tested.
Percentage/Number of Subjects With Seroprotection for Anti-measles Virus Immunoglobulin G (IgG)
Time frame: 8 weeks post vaccination
Used commercially available indirect enzyme-linked IgG immunoassays (EIAs; Wampole Laboratories, Princeton, New Jersey). An index standard ratio (ISR) of ≥1.10 on both runs of the respective assay was considered evidence of seropositivity for measles virus. All measles virus and rubella virus assays were performed at the National Measles and Rubella Reference Laboratories, Measles, Mumps, Rubella, and Herpesviruses Branch, Division of Viral Diseases, Centers for Disease Control and Prevention (Atlanta, Georgia).
12 secondary outcomes
Percentage/Number of Subjects With Seroconversion for Anti-rubella Virus Immunoglobulin G (IgG)
Time frame: 8 weeks post vaccination
Geometric Mean Concentration (GMC) for Anti-rubella Virus Immunoglobulin G (IgG)
Time frame: 8 weeks post vaccination
Percentage/Number of Subjects Seropositive for Anti-rotavirus Immunoglobulin A (IgA)
Time frame: Visit 1 (pre-vaccination) and 8 weeks post vaccination
Geometric Mean Titer (GMT) of Anti-rotavirus Immunoglobulin A (IgA)
Time frame: Visit 1 (pre-vaccination) and 8 weeks post vaccination
Percentage/Number of Subjects Seropositive for Anti-rotavirus Immunoglobulin G (IgG)
Time frame: Visit 1 (pre-vaccination) and 8 weeks post vaccination
Geometric Mean Titer (GMT) of Anti-rotavirus Immunoglobulin G (IgG)
Time frame: Visit 1 (pre-vaccination) and 8 weeks post vaccination
Percentage/Number of Subjects With Seroconversion for Anti-rotavirus Immunoglobulin A (IgA)
Time frame: 8 weeks post vaccination
Percentage/Number of Subjects With Seroconversion for Anti-rotavirus Immunoglobulin G (IgG)
Time frame: 8 weeks post vaccination
Number/Percentage of Subjects Experiencing Immediate Post-vaccination Reactions Following Administration of Vaccine
Time frame: 30 minutes post-vaccination
Number/Percentage of Subjects Experiencing Solicited Adverse Events
Time frame: 14 days post-vaccination
Number/Percentage of Subjects Experiencing Unsolicited Non-serious Adverse Events
Time frame: 14 days post-vaccination
Number/Percentage of Subjects Experiencing Serious Adverse Events
Time frame: 2 months after vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26823338Zaman K, Fleming JA, Victor JC, Yunus M, Bari TI, Azim T, Rahman M, Mowla SM, Bellini WJ, McNeal M, Icenogle JP, Lopman B, Parashar U, Cortese MM, Steele AD, Neuzil KM. Noninterference of Rotavirus Vaccine With Measles-Rubella Vaccine at 9 Months of Age and Improvements in Antirotavirus Immunity: A Randomized Trial. J Infect Dis. 2016 Jun 1;213(11):1686-93. doi: 10.1093/infdis/jiw024. Epub 2016 Jan 27.
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.
K Zaman, PhD, MPH principal investigator
International Centre for Diarrhoeal Disease Research, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rotarix vaccine and measles-rubella vaccine in people with Measles Antibody Seroconversion and Rubella Antibody Seroconversion, run by PATH at 1 site in Bangladesh.
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 9 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 13 Mar 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 Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 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?
Percentage/Number of Subjects With Seroprotection for Measles Virus Serum Neutralization Antibodies (time frame: 8 weeks post vaccination). The study lists 2 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 NCT01700621, 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 13 Mar 2019.