Influenza and PneumoniaPhase 4NCT05471531
Study on Combined Vaccination With Quadrivalent Influenza Vaccine and 23-valent Pneumococcal Polysaccharide Vaccine
A Phase 4 study testing Combined vaccination with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine and Separate vaccination with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine in people with Influenza and Pneumonia, run by Sinovac Biotech Co., Ltd at 4 sites in China.
Trial summary
This study is an open-label,single center phase Ⅳ clinical trial of combined immunization with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine.The purpose of this study is to evaluate the safety and immunogenicity of combined immunization with quadrivalent influenza vaccine and… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza and Pneumonia
- What is being tested?
- Combined vaccination with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine and Separate vaccination with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 4 sitesChina
- Study dates
- 13 Nov 2021to 10 Jul 2022
- Phase
- Phase 4
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The elderly aged 60 and above;
- The subjects and/or guardians can understand and voluntarily sign the informed consent form;
- Proven legal identity.
Who cannot join
- Received any circulating seasonal influenza vaccine prior to enrollment;
- Have received any pneumococcal vaccine within 5 years;
- History of severe allergic reactions to vaccines (such as acute anaphylaxis, angioneurotic edema, dyspnea, etc.);
- History of uncontrolled epilepsy and other serious neurological disorders (e.g.transverse myelitis, Guillain-Barre syndrome, demyelinating disease, etc.)
- Fever,acute onset of chronic disease,severe uncontrolled chronic disease or acute disease at the time of vaccination;
- Receipt of other investigational drugs in the past 30 days;
Show all 9Show fewer
- Receipt of attenuated live vaccines in the past 14 days;
- Receipt of inactivated or subunit vaccines in the past 7 days;
- According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Jingjiang Center for Diseases Control and Prevention
Taizhou, Jiangsu, 214527
Taizhou City Hospital of Traditional Chinese and Western Medicine
Taizhou, Jiangsu, 225309
Gaogang District Center for Disease Control and Prevention
Taizhou, Jiangsu, 225323
Xinghua Center for Disease Control and Prevention
Taizhou, Jiangsu, 225799
About this study
Official title: Immunogenicity and Safety of Quadrivalent Influenza Vaccine Combined Immunization With 23-valent Pneumococcal Polysaccharide Vaccine in the Elderly Aged 60 Years and Above
This study is an open-label,single center phase Ⅳ clinical trial of combined immunization with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine.The purpose of this study is to evaluate the safety and immunogenicity of combined immunization with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine in the elderly aged 60 years and above.
Read the detailed description
This study is an open-label,single center,phase IV clinical trial in the elderly aged 60 Years and above.The experimental vaccines were manufactured by Sinovac Biotech Co., Ltd. A total of 3000 subjects will be enrolled,the safety and immunogenicity of combined immunization were evaluated in 480 subjects,and the Safety observation of combined immunization was evaluated in the extended safety group, which included 2520 subjects.
- Conditions
- Influenza and Pneumonia
- Being tested
- Combined vaccination with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine, Separate vaccination with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine
- Medical subject headings
- Influenza, Human, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined vaccination with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccineBiological
Quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine were manufactured by Sinovac Biotech Co., Ltd.The routine of administration is intramuscular injection into deltoid region.And the immunization schedule is one dose of quadrivalent influenza vaccine and one dose of 23-valent pneumococcal polysaccharide vaccine on day 0.
Separate vaccination with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccineBiological
Quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine were manufactured by Sinovac Biotech Co., Ltd.The routine of administration is intramuscular injection into deltoid region.And the immunization schedule is one dose of quadrivalent influenza vaccine on day 0 and one dose of 23-valent pneumococcal polysaccharide vaccine on day 28 in subgroup 1,and one dose of 23-valent pneumococcal polysaccharide vaccine on day 0 and one dose of quadrivalent influenza vaccine on day 28 in subgroup 2.
| Study group | Role | What they receive |
|---|---|---|
| Combined immunization group | Experimental | 160 subjects received one dose of quadrivalent influenza vaccine and one dose of 23-valent pneumococcal polysaccharide vaccine on day 0. Receives: Biological: Combined vaccination with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine |
| Non combined immunization group | Experimental | There were two subgroups in non combined immunization group,and 160 subjects in each subgroup.The non combined immunization subgroup 1 received one dose of quadrivalent influenza vaccine on day 0 and one dose of 23-valent pneumococcal polysaccharide vaccine on day 28.The non combined immunization subgroup 2 received one dose of 23-valent pneumococcal polysaccharide vaccine on day 0 and one dose of quadrivalent influenza vaccine on day 28. Receives: Biological: Separate vaccination with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine |
| Safety group | Experimental | 2520 subjects were enrolled and received one dose of quadrivalent influenza vaccine and one dose of 23-valent pneumococcal polysaccharide vaccine on day 0. Receives: Biological: Combined vaccination with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity index of Geometric mean titer(GMT) of influenza HI antibodies
GMT of influenza HI antibodies for each influenza strain at 28 days after combined vaccination .
Measured: 28 days after combined vaccination
Secondary outcomes (19)
Immunogenicity index of the seroconversion rates of influenza HI antibodies
Seroconversion rate of influenza HI antibodies for each influenza strain at 28 days after combined vaccination.
Measured: 28 days after combined vaccination
Immunogenicity index of Geometric Mean Increase (GMI) of influenza HI antibodies
GMI of influenza HI antibodies for each influenza strain at 28 days after combined vaccination.
Measured: 28 days after combined vaccination
Immunogenicity index of seropositivity rates of influenza HI antibodies
Seropositivity rates of influenza HI antibodies for each influenza strain at 28 days after combined vaccination.
Measured: 28 days after combined vaccination
Immunogenicity index of Geometric Mean Concentration (GMC) for 23 serotypes specificity of pneumococcal IgG antibody
GMC for 23 serotypes specificity of pneumococcal IgG antibody at 28 days after combined vaccination.
Measured: 28 days after combined vaccination
Immunogenicity index-seroconversion rates for 23 serotypes specificity of pneumococcal IgG antibody
Seroconversion rates for 23 serotypes specificity of pneumococcal IgG antibody at 28 days after combined vaccination.
Measured: 28 days after combined vaccination
Immunogenicity index-GMI for 23 serotypes specificity of pneumococcal IgG antibody
GMI for 23 serotypes specificity of pneumococcal IgG antibody at 28 days after combined vaccination.
Measured: 28 days after combined vaccination
Geometric mean titer(GMT) of influenza HI antibodies
GMT of influenza HI antibodies for each influenza strain at 28 days after a single injection of quadrivalent influenza vaccine.
Measured: 28 days after a single injection of quadrivalent influenza vaccine
Seroconversion rates of influenza HI antibodies
Seroconversion rates of influenza HI antibodies for each influenza strain at 28 days after a single injection of quadrivalent influenza vaccine.
Measured: 28 days after a single injection of quadrivalent influenza vaccine
Geometric Mean Increase (GMI) of influenza HI antibodies
GMI of influenza HI antibodies for each influenza strain at 28 days after a single injection of quadrivalent influenza vaccine.
Measured: 28 days after a single injection of quadrivalent influenza vaccine
Seropositivity rates of influenza HI antibodies
Seropositivity rates of influenza HI antibodies for each influenza strain at 28 days after a single injection of quadrivalent influenza vaccine.
Measured: 28 days after a single injection of quadrivalent influenza vaccine
Geometric Mean Concentration (GMC) for 23 serotypes specificity of pneumococcal IgG antibody
GMC for 23 serotypes specificity of pneumococcal IgG antibody at 28 days after a single injection of 23-valent pneumococcal polysaccharide vaccine.
Measured: 28 days after a single injection of 23-valent pneumococcal polysaccharide vaccine
Seroconversion rates for 23 serotypes specificity of pneumococcal IgG antibody
Seroconversion rates for 23 serotypes specificity of pneumococcal IgG antibody at 28 days after a single injection of 23-valent pneumococcal polysaccharide vaccine.
Measured: 28 days after a single injection of 23-valent pneumococcal polysaccharide vaccine
GMI for 23 serotypes specificity of pneumococcal IgG antibody
GMI for 23 serotypes specificity of pneumococcal IgG antibody at 28 days after a single injection of 23-valent pneumococcal polysaccharide vaccine.
Measured: 28 days after a single injection of 23-valent pneumococcal polysaccharide vaccine
Safety index-incidence of adverse reactions
Incidence of adverse reactions at 0~7 after combined immunization with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine.
Measured: Within 7 days after combined immunization
Safety index-Incidence of adverse reactions
Incidence of adverse reactions at 0~28 after combined immunization with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine.
Measured: Within 28 days after combined immunization
Incidence of adverse reactions after a single injection of quadrivalent influenza vaccine
Incidence of adverse reactions at 0~7 after a single injection of quadrivalent influenza vaccine.
Measured: Within 7 days after a single injection of quadrivalent influenza vaccine
The incidence of adverse reactions after a single injection of quadrivalent influenza vaccine
Incidence of adverse reactions at 0~28 after a single injection of quadrivalent influenza vaccine.
Measured: Within 28 days after a single injection of quadrivalent influenza vaccine
Incidence of adverse reactions after a single injection of 23-valent pneumococcal polysaccharide vaccine
Incidence of adverse reactions at 0~7 after a single injection of 23-valent pneumococcal polysaccharide vaccine.
Measured: Within 7 days after a single injection of 23-valent pneumococcal polysaccharide vaccine
The incidence of adverse reactions after a single injection of 23-valent pneumococcal polysaccharide vaccine
Incidence of adverse reactions at 0~28 after a single injection of 23-valent pneumococcal polysaccharide vaccine.
Measured: Within 28 days after a single injection of 23-valent pneumococcal polysaccharide vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start13 Nov 2021
- Primary completion10 Mar 2022
- Study completion10 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza and PneumoniaStudies of the same condition, open and under way.
- More trials run by Sinovac Biotech Co., LtdThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinovac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhongkui Zhu, Master, Principal investigator, Taizhou Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05471531
- Sponsor's protocol ID
- PRO-INF4-MA4002-JStz
- Status last verified
- Jul 2022
- First submitted
- 13 Jul 2022
- Last updated
- 25 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of Quadrivalent Influenza Vaccine Combined Immunization With 23-valent Pneumococcal Polysaccharide Vaccine in the Elderly Aged 60 Years and Above
- ClinicalTrials.gov ID
- NCT05471531
- Acronym / sponsor ID
- PRO-INF4-MA4002-JStz
- Conditions
- Influenza and Pneumonia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2021 (actual)
- Primary completion
- 10 Mar 2022 (actual)
- Study completion
- 10 Jul 2022 (actual)
- First posted
- 25 Jul 2022 (actual)
- 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 is an open-label,single center phase Ⅳ clinical trial of combined immunization with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine.The purpose of this study is to evaluate the safety and immunogenicity of combined immunization with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine in the elderly aged 60 years and above.
Detailed description
This study is an open-label,single center,phase IV clinical trial in the elderly aged 60 Years and above.The experimental vaccines were manufactured by Sinovac Biotech Co., Ltd. A total of 3000 subjects will be enrolled,the safety and immunogenicity of combined immunization were evaluated in 480 subjects,and the Safety observation of combined immunization was evaluated in the extended safety group, which included 2520 subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Combined immunization group | Experimental | Biological: Combined vaccination with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine160 subjects received one dose of quadrivalent influenza vaccine and one dose of 23-valent pneumococcal polysaccharide vaccine on day 0. |
| Non combined immunization group | Experimental | Biological: Separate vaccination with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccineThere were two subgroups in non combined immunization group,and 160 subjects in each subgroup.The non combined immunization subgroup 1 received one dose of quadrivalent influenza vaccine on day 0 and one dose of 23-valent pneumococcal polysaccharide vaccine on day 28.The non combined immunization subgroup 2 received one dose of 23-valent pneumococcal polysaccharide vaccine on day 0 and one dose of quadrivalent influenza vaccine on day 28. |
| Safety group | Experimental | Biological: Combined vaccination with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine2520 subjects were enrolled and received one dose of quadrivalent influenza vaccine and one dose of 23-valent pneumococcal polysaccharide vaccine on day 0. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The elderly aged 60 and above;
- The subjects and/or guardians can understand and voluntarily sign the informed consent form;
- Proven legal identity.
Key exclusion criteria (9 listed)
- Received any circulating seasonal influenza vaccine prior to enrollment;
- Have received any pneumococcal vaccine within 5 years;
- History of severe allergic reactions to vaccines (such as acute anaphylaxis, angioneurotic edema, dyspnea, etc.);
- History of uncontrolled epilepsy and other serious neurological disorders (e.g.transverse myelitis, Guillain-Barre syndrome, demyelinating disease, etc.)
- Fever,acute onset of chronic disease,severe uncontrolled chronic disease or acute disease at the time of vaccination;
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 |
|---|---|---|
| Combined vaccination with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccineQuadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine were manufactured by Sinovac Biotech Co., Ltd.The routine of administration is intramuscular injection into deltoid region.And the immunization schedule is one dose of quadrivalent influenza vaccine and one dose of 23-valent pneumococcal polysaccharide vaccine on day 0. | Biological | Combined immunization group, Safety group |
| Separate vaccination with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccineQuadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine were manufactured by Sinovac Biotech Co., Ltd.The routine of administration is intramuscular injection into deltoid region.And the immunization schedule is one dose of quadrivalent influenza vaccine on day 0 and one dose of 23-valent pneumococcal polysaccharide vaccine on day 28 in subgroup 1,and one dose of 23-valent pneumococcal polysaccharide vaccine on day 0 and one dose of quadrivalent influenza vaccine on day 28 in subgroup 2. | Biological | Non combined immunization group |
Primary outcome
Immunogenicity index of Geometric mean titer(GMT) of influenza HI antibodies
Time frame: 28 days after combined vaccination
GMT of influenza HI antibodies for each influenza strain at 28 days after combined vaccination .
19 secondary outcomes
Immunogenicity index of the seroconversion rates of influenza HI antibodies
Time frame: 28 days after combined vaccination
Immunogenicity index of Geometric Mean Increase (GMI) of influenza HI antibodies
Time frame: 28 days after combined vaccination
Immunogenicity index of seropositivity rates of influenza HI antibodies
Time frame: 28 days after combined vaccination
Immunogenicity index of Geometric Mean Concentration (GMC) for 23 serotypes specificity of pneumococcal IgG antibody
Time frame: 28 days after combined vaccination
Immunogenicity index-seroconversion rates for 23 serotypes specificity of pneumococcal IgG antibody
Time frame: 28 days after combined vaccination
Immunogenicity index-GMI for 23 serotypes specificity of pneumococcal IgG antibody
Time frame: 28 days after combined vaccination
Geometric mean titer(GMT) of influenza HI antibodies
Time frame: 28 days after a single injection of quadrivalent influenza vaccine
Seroconversion rates of influenza HI antibodies
Time frame: 28 days after a single injection of quadrivalent influenza vaccine
Geometric Mean Increase (GMI) of influenza HI antibodies
Time frame: 28 days after a single injection of quadrivalent influenza vaccine
Seropositivity rates of influenza HI antibodies
Time frame: 28 days after a single injection of quadrivalent influenza vaccine
Geometric Mean Concentration (GMC) for 23 serotypes specificity of pneumococcal IgG antibody
Time frame: 28 days after a single injection of 23-valent pneumococcal polysaccharide vaccine
Seroconversion rates for 23 serotypes specificity of pneumococcal IgG antibody
Time frame: 28 days after a single injection of 23-valent pneumococcal polysaccharide vaccine
GMI for 23 serotypes specificity of pneumococcal IgG antibody
Time frame: 28 days after a single injection of 23-valent pneumococcal polysaccharide vaccine
Safety index-incidence of adverse reactions
Time frame: Within 7 days after combined immunization
Safety index-Incidence of adverse reactions
Time frame: Within 28 days after combined immunization
Incidence of adverse reactions after a single injection of quadrivalent influenza vaccine
Time frame: Within 7 days after a single injection of quadrivalent influenza vaccine
The incidence of adverse reactions after a single injection of quadrivalent influenza vaccine
Time frame: Within 28 days after a single injection of quadrivalent influenza vaccine
Incidence of adverse reactions after a single injection of 23-valent pneumococcal polysaccharide vaccine
Time frame: Within 7 days after a single injection of 23-valent pneumococcal polysaccharide vaccine
The incidence of adverse reactions after a single injection of 23-valent pneumococcal polysaccharide vaccine
Time frame: Within 28 days after a single injection of 23-valent pneumococcal polysaccharide vaccine
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 25 Jul 2022.
Related trials for Influenza and Pneumonia
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingObservational study
Clinical Outcomes and Pharmacotherapy Effectiveness in the VA Health Care System (COPE-VA)
COVID-19, SARS-CoV-2 Infection, RSV
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
RecruitingPhase 3
Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen
Viral Lung Infection and Acute Respiratory Failure
Active, not recruitingObservational study
A Study to Look at the Health Outcomes of Patients With COVID-19 and Influenza
COVID-19, Coronavirus Disease 2019
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.
Zhongkui Zhu, Master principal investigator
Taizhou Center for Disease Control and Prevention
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Combined vaccination with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine and Separate vaccination with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine in people with Influenza and Pneumonia, run by Sinovac Biotech Co., Ltd at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 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 25 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. 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?
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?
Immunogenicity index of Geometric mean titer(GMT) of influenza HI antibodies (time frame: 28 days after combined vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jul 2022.