Pneumococcal VaccinesPhase 2NCT05844423
Safety, Tolerability, and Immunogenicity of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Healthy Infants
A Phase 2 study testing 0.5 ml dose of 1.1 mcg VAX-24, 0.5 ml dose of PCV20 and 0.5 ml dose of 2.2 mcg VAX-24 in people with Pneumococcal Vaccines, run by Vaxcyte, Inc. at 32 sites in United States.
Trial summary
The objective of the study is to evaluate the safety and tolerability of 4 injections of VAX-24 (at 3 dose levels) compared to PCV15 in infants at 2, 4, 6, and 12-15 months of age, in addition to receiving routine US concomitant vaccines. Stage 1 of the study will comprise 3 dose ascending cohorts. Read more about this study
- Who is it for?
- Ages 42 to 89 daysHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Vaccines
- What is being tested?
- 0.5 ml dose of 1.1 mcg VAX-24, 0.5 ml dose of PCV20 and 0.5 ml dose of 2.2 mcg VAX-24
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 802 participants
- Where
- 32 sitesUnited States
- Study dates
- 29 Mar 2023to 25 Aug 2025
- Phase
- Phase 2
- 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 42 to 89 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy male or female infant ≥42 days to ≤89 days (inclusive).
- Full-term infant at least 37 weeks gestational age at birth.
- Afebrile for ≥72 hours with a rectal temperature <38.0°C (<100.4°F) or axillary temperature <37.8°C (<100.0°F) before receipt of study vaccine.*
- Able to attend all scheduled visits and comply with the study procedures.
- Subject's parent/legal guardian is able to read and understands the study procedures, alternate treatments, risks and benefits, and provides written informed consent.
- Subject's parent/legal guardian is able to fill out an ediary of solicited AE and take daily axillary temperature and measurements of local injection site reactions for the 7 days after each study vaccination.
- Subject's parent/legal guardian has an e-mail address and access to a computer or smartphone with internet to complete the ediary.
Who cannot join
- History of invasive pneumococcal disease (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease.
- Previous receipt of a licensed or investigational vaccine (excluding 1 dose hepatitis B vaccine).
- Known hypersensitivity to any vaccine.
- Known or suspected impairment of immunological function (e.g., asplenia, HIV, primary immunodeficiency).
- Use of any immunosuppressive therapy (Note: topical and inhaled/nebulized steroids are permitted).
- History of failure to thrive.
Show all 14Show fewer
- Subject has a coagulation disorder contraindicating IM vaccination.
- Subject or his/her mother have documented hepatitis B surface antigen-positive.
- Has a known neurologic or cognitive behavioral disorder.
- Has a known clinically significant congenital malformation or serious chronic disorder.
- Receipt of a blood transfusion or blood products, including immunoglobulins.
- Receipt of any investigational study product since birth, currently participating in another interventional investigational study, or having plans to receive another investigational product(s) while on study.
- Any infant who cannot be adequately followed for safety according to the protocol plan.
- Any other reason that in the opinion of the investigator may interfere with the evaluation required by the study.
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United States32 sites
Kentucky Pediatric/ Adult Research
Bardstown, Kentucky, 40004
Ventavia Research Group
Burleson, Texas, 76028
Pediatric Research of Charlottesville, LLC
Charlottesville, Virginia, 22902
UPMC Bass Wolfson Cranberry
Cranberry Township, Pennsylvania, 16066
Ohio Pediatric Research Assn.
Dayton, Ohio, 45414
Allegheny Health and Wellness Pavilion
Erie, Pennsylvania, 16506
Meridian Clinical Research
Hastings, Nebraska, 68901
ACC Pediatric Research
Haughton, Louisiana, 71037
Ventavia
Houston, Texas, 77008
Kool Kids Pediatrics
Houston, Texas, 77065
Pediatric Associates
Houston, Texas, 77087
UPMC Children's Community Pediatrics South Hills-Jefferson Hills
Jefferson Hills, Pennsylvania, 15025
The Children's Clinic of Jonesboro, P.A.
Jonesboro, Arkansas, 72401
Holston Medical Group
Kingsport, Tennessee, 37660
Alliance for Multispecialty Research
Layton, Utah, 84041
Midwest Children's Health Research Institute
Lincoln, Nebraska, 68504
Midwest Children's Health Research Institute
Lincoln, Nebraska, 68505
Midwest Children's Health Research Institute
Lincoln, Nebraska, 68516
Midwest Children's Health Research Institute
Lincoln, Nebraska, 68522
Madera Family Medical Group
Madera, California, 93637
Alliance for Multispecialty Research
Murray, Utah, 84107
Palmetto Pediatrics, PA
North Charleston, South Carolina, 29406
UPMC Primary Care Center Oakland
Pittsburgh, Pennsylvania, 15213
UPMC Children's Community Pediatrics Bass Wolfson-Squirrel Hill
Pittsburgh, Pennsylvania, 15217
UPMC Children's Community Pediatrics-Castle Shannon
Pittsburgh, Pennsylvania, 15234
Alliance for Multispecialty Research
Provo, Utah, 84604
Pediatric Center
Richmond, Texas, 77469
Alliance for Multispecialty Research
Roy, Utah, 84067
Tribe Clinical Research at Parkside Pediatrics
Simpsonville, South Carolina, 29680
Coastal Pediatric Research
Summerville, South Carolina, 29486
Alliance for Multispecialty Research
Syracuse, Utah, 84075
Jedidiah Clinical Research
Tampa, Florida, 33617
About this study
Official title: Randomized, Observer-Blind, Active-Controlled, Dose-Finding Study to Evaluate the Safety, Tolerability, and Immunogenicity of 24-Valent PCV (VAX-24) in Infants Given 4 Doses at 2, 4, 6, and 12-15 Months of Age With Pediatric Vaccines
The objective of the study is to evaluate the safety and tolerability of 4 injections of VAX-24 (at 3 dose levels) compared to PCV15 in infants at 2, 4, 6, and 12-15 months of age, in addition to receiving routine US concomitant vaccines. Stage 1 of the study will comprise 3 dose ascending cohorts. Stage 2 of the study will enroll the remainder of the sample size.
- Conditions
- Pneumococcal Vaccines
- Being tested
- 0.5 ml dose of 1.1 mcg VAX-24, 0.5 ml dose of PCV20, 0.5 ml dose of 2.2 mcg VAX-24, 0.5 ml dose of 2.2/4.4 mcg VAX-24
- Keywords
- 24 valent PCV, Pneumonia, Pneumococcal Infection
- Medical subject headings
- Pneumonia, Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5 ml dose of 1.1 mcg VAX-24Biological
24 valent pneumococcal conjugate vaccine
0.5 ml dose of PCV20Biological
20 valent pneumococcal conjugate vaccine
0.5 ml dose of 2.2 mcg VAX-24Biological
24 valent pneumococcal conjugate vaccine
0.5 ml dose of 2.2/4.4 mcg VAX-24Biological
24 valent pneumococcal conjugate vaccine
| Study group | Role | What they receive |
|---|---|---|
| VAX-24 Low | Experimental | Participants will receive 4 doses of VAX-24 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of three dose levels. Receives: Biological: 0.5 ml dose of 1.1 mcg VAX-24 |
| VAX-24 Mid | Experimental | Participants will receive 4 doses of VAX-24 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of three dose levels. Receives: Biological: 0.5 ml dose of 2.2 mcg VAX-24 |
| VAX-24 Mixed | Experimental | Participants will receive 4 doses of VAX-24 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of three dose levels. Receives: Biological: 0.5 ml dose of 2.2/4.4 mcg VAX-24 |
| PCV20 | Active comparator | Participants will receive 4 doses of PCV20 administered as an intramuscular injection of the standard dose at 2, 4, 6, and 12-15 months of age. Receives: Biological: 0.5 ml dose of PCV20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with any solicited local injection site Adverse Events (AE) within 7 days after each vaccination
Solicited local reactions include erythema, edema, and tenderness at the injection site
Measured: 7 days after each vaccination
Percentage of participants with any solicited systemic AE within 7 days after each vaccination
Solicited systemic reactions include fever, irritability, decreased appetite, decreased sleep, and increased sleep
Measured: 7 days after each vaccination
Percentage of participants with any related Serious Adverse Events (SAE) within 6 months after last vaccination
Percentage of participants with related SAE
Measured: 6 months after last vaccination
Secondary outcomes (16)
Percentage of subjects with any unsolicited AE within 1 month after each vaccination
Percentage of subjects with any unsolicited AE
Measured: 1 month after each vaccination
Percentage of subjects with any unsolicited AE from Dose 1 through 1 month post-Dose 3
Percentage of subjects with any unsolicited AE between first and 3rd vaccination in the primary series
Measured: First vaccination (Dose 1) through 1 month after third vaccination (Dose 3)
Percentage of subjects with any AE resulting in discontinuation of study within 6 months after last vaccination
Percentage of subjects with any AE resulting in discontinuation of study
Measured: 6 months after last vaccination
Percentage of subjects with any new onset of chronic illness (NOCI) within 6 months after last vaccination
Percentage of subjects with any NOCI
Measured: 6 months after last vaccination
Percentage of subjects with any medically attended adverse events (MAAE) within 6 months after last vaccination
Percentage of subjects with any MAAE
Measured: 6 months after last vaccination
Percentage of subjects with any SAE within 6 months after last vaccination
Percentage of subjects with any SAE
Measured: 6 months after last vaccination
Percentage of subjects achieving an anti-pneumococcal Immunoglobulin G (IgG) antibody concentration ≥0.35 mcg/mL 1 month after Dose 3
Percentage of subjects achieving an anti-pneumococcal IgG antibody concentration ≥0.35 mcg/mL
Measured: 1 month after Dose 3
Percentage of subjects achieving an anti-pneumococcal IgG antibody concentration ≥0.35 mcg/mL 1 month after Dose 4
Percentage of subjects achieving an anti-pneumococcal IgG antibody concentration ≥0.35 mcg/mL
Measured: 1 month after Dose 4
IgG antibody Geometric Mean Concentration (GMC) 1 month after Dose 3
Antibody geometric mean concentrations as measured by IgG for the 24 pneumococcal serotypes in VAX-24
Measured: 1 month after Dose 3
IgG antibody GMC 1 month after Dose 4
Antibody geometric mean concentrations as measured by IgG for the 24 pneumococcal serotypes in VAX-24
Measured: 1 month after Dose 4
Opsonophagocytic activity (OPA) Geometric Mean Titer (GMT) 1 month after Dose 3
Antibody geometric mean titers s as measured by OPA for the 24 pneumococcal serotypes in VAX-24
Measured: 1 month after Dose 3
OPA GMT 1 month after Dose 4
Antibody geometric mean titers s as measured by OPA for the 24 pneumococcal serotypes in VAX-24
Measured: 1 month after Dose 4
IgG Geometric Mean Fold Ratio (GMFR) before Dose 4 to 1 month after Dose 4
Antibody geometric mean fold ratio as measured by IgG for the 24 pneumococcal serotypes in VAX-24
Measured: Pre-Dose 4 to 1 month after Dose 4
OPA GMFR before Dose 4 to 1 month after Dose 4
Antibody geometric mean fold rise as measured by OPA for the 24 pneumococcal serotypes in VAX-24
Measured: Pre-Dose 4 to 1 month after Dose 4
Percentage of subjects achieving at least a 4-fold increase in IgG from pre-Dose 4 to 1 month post Dose 4
Geometric mean concentration with a at least a 4-fold increase in IgG antibodies for the 24 pneumococcal serotypes in VAX-24
Measured: Pre-Dose 4 to 1 month after Dose 4
Percentage of subjects achieving at least a 4-fold increase in OPA titers from pre-Dose 4 to 1 month post Dose 4
Geometric mean titer with a at least a 4-fold increase in OPA titers for the 24 pneumococcal serotypes in VAX-24
Measured: Pre-Dose 4 to 1 month after Dose 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start29 Mar 2023
- Primary completion25 Aug 2025
- Study completion25 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal VaccinesStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 802 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vaxcyte, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05844423
- Sponsor's protocol ID
- VAX24-112
- Status last verified
- Sep 2025
- First submitted
- 24 Apr 2023
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Vaxcyte is committed to providing access to anonymized data from the company's clinical trials for the purpose of legitimate scientific research. Requests for data may be addressed to datasharing@vaxcyte.com. Requests must be accompanied by a detailed analysis plan and will be reviewed for scientific validity. Data will be made available after initial product approval. Sharing of data may require execution of a data-sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Observer-Blind, Active-Controlled, Dose-Finding Study to Evaluate the Safety, Tolerability, and Immunogenicity of 24-Valent PCV (VAX-24) in Infants Given 4 Doses at 2, 4, 6, and 12-15 Months of Age With Pediatric Vaccines
- ClinicalTrials.gov ID
- NCT05844423
- Acronym / sponsor ID
- VAX24-112
- Conditions
- Pneumococcal Vaccines
- Keywords
- 24 valent PCV, Pneumonia, Pneumococcal Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 802 participants (actual)
- Lead sponsor
- Vaxcyte, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Mar 2023 (actual)
- Primary completion
- 25 Aug 2025 (actual)
- Study completion
- 25 Aug 2025 (actual)
- First posted
- 6 May 2023 (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.
The objective of the study is to evaluate the safety and tolerability of 4 injections of VAX-24 (at 3 dose levels) compared to PCV15 in infants at 2, 4, 6, and 12-15 months of age, in addition to receiving routine US concomitant vaccines. Stage 1 of the study will comprise 3 dose ascending cohorts. Stage 2 of the study will enroll the remainder of the sample size.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| VAX-24 Low | Experimental | Biological: 0.5 ml dose of 1.1 mcg VAX-24Participants will receive 4 doses of VAX-24 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of three dose levels. |
| VAX-24 Mid | Experimental | Biological: 0.5 ml dose of 2.2 mcg VAX-24Participants will receive 4 doses of VAX-24 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of three dose levels. |
| VAX-24 Mixed | Experimental | Biological: 0.5 ml dose of 2.2/4.4 mcg VAX-24Participants will receive 4 doses of VAX-24 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of three dose levels. |
| PCV20 | Active comparator | Biological: 0.5 ml dose of PCV20Participants will receive 4 doses of PCV20 administered as an intramuscular injection of the standard dose at 2, 4, 6, and 12-15 months of age. |
Who may qualify
- Ages
- 42 to 89 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Healthy male or female infant ≥42 days to ≤89 days (inclusive).
- Full-term infant at least 37 weeks gestational age at birth.
- Afebrile for ≥72 hours with a rectal temperature <38.0°C (<100.4°F) or axillary temperature <37.8°C (<100.0°F) before receipt of study vaccine.*
- Able to attend all scheduled visits and comply with the study procedures.
- Subject's parent/legal guardian is able to read and understands the study procedures, alternate treatments, risks and benefits, and provides written informed consent.
Key exclusion criteria (14 listed)
- History of invasive pneumococcal disease (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease.
- Previous receipt of a licensed or investigational vaccine (excluding 1 dose hepatitis B vaccine).
- Known hypersensitivity to any vaccine.
- Known or suspected impairment of immunological function (e.g., asplenia, HIV, primary immunodeficiency).
- Use of any immunosuppressive therapy (Note: topical and inhaled/nebulized steroids are permitted).
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 |
|---|---|---|
| 0.5 ml dose of 1.1 mcg VAX-2424 valent pneumococcal conjugate vaccine | Biological | VAX-24 Low |
| 0.5 ml dose of PCV2020 valent pneumococcal conjugate vaccine | Biological | PCV20 |
| 0.5 ml dose of 2.2 mcg VAX-2424 valent pneumococcal conjugate vaccine | Biological | VAX-24 Mid |
| 0.5 ml dose of 2.2/4.4 mcg VAX-2424 valent pneumococcal conjugate vaccine | Biological | VAX-24 Mixed |
Primary outcome
Percentage of participants with any solicited local injection site Adverse Events (AE) within 7 days after each vaccination
Time frame: 7 days after each vaccination
Solicited local reactions include erythema, edema, and tenderness at the injection site
Percentage of participants with any solicited systemic AE within 7 days after each vaccination
Time frame: 7 days after each vaccination
Solicited systemic reactions include fever, irritability, decreased appetite, decreased sleep, and increased sleep
Percentage of participants with any related Serious Adverse Events (SAE) within 6 months after last vaccination
Time frame: 6 months after last vaccination
Percentage of participants with related SAE
16 secondary outcomes
Percentage of subjects with any unsolicited AE within 1 month after each vaccination
Time frame: 1 month after each vaccination
Percentage of subjects with any unsolicited AE from Dose 1 through 1 month post-Dose 3
Time frame: First vaccination (Dose 1) through 1 month after third vaccination (Dose 3)
Percentage of subjects with any AE resulting in discontinuation of study within 6 months after last vaccination
Time frame: 6 months after last vaccination
Percentage of subjects with any new onset of chronic illness (NOCI) within 6 months after last vaccination
Time frame: 6 months after last vaccination
Percentage of subjects with any medically attended adverse events (MAAE) within 6 months after last vaccination
Time frame: 6 months after last vaccination
Percentage of subjects with any SAE within 6 months after last vaccination
Time frame: 6 months after last vaccination
Percentage of subjects achieving an anti-pneumococcal Immunoglobulin G (IgG) antibody concentration ≥0.35 mcg/mL 1 month after Dose 3
Time frame: 1 month after Dose 3
Percentage of subjects achieving an anti-pneumococcal IgG antibody concentration ≥0.35 mcg/mL 1 month after Dose 4
Time frame: 1 month after Dose 4
IgG antibody Geometric Mean Concentration (GMC) 1 month after Dose 3
Time frame: 1 month after Dose 3
IgG antibody GMC 1 month after Dose 4
Time frame: 1 month after Dose 4
Opsonophagocytic activity (OPA) Geometric Mean Titer (GMT) 1 month after Dose 3
Time frame: 1 month after Dose 3
OPA GMT 1 month after Dose 4
Time frame: 1 month after Dose 4
IgG Geometric Mean Fold Ratio (GMFR) before Dose 4 to 1 month after Dose 4
Time frame: Pre-Dose 4 to 1 month after Dose 4
OPA GMFR before Dose 4 to 1 month after Dose 4
Time frame: Pre-Dose 4 to 1 month after Dose 4
Percentage of subjects achieving at least a 4-fold increase in IgG from pre-Dose 4 to 1 month post Dose 4
Time frame: Pre-Dose 4 to 1 month after Dose 4
Percentage of subjects achieving at least a 4-fold increase in OPA titers from pre-Dose 4 to 1 month post Dose 4
Time frame: Pre-Dose 4 to 1 month after Dose 4
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 11 Sep 2025.
- Individual participant dataSharing planned: Yes. Vaxcyte is committed to providing access to anonymized data from the company's clinical trials for the purpose of legitimate scientific research. Requests for data may be addressed to datasharing@vaxcyte.com. Requests must be accompanied by a detailed analysis plan and will be reviewed for scientific validity. Data will be made available after initial product approval. Sharing of data may require execution of a data-sharing agreement.
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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.
The record lists no contact. Use the official record to reach the sponsor.
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 0.5 ml dose of 1.1 mcg VAX-24, 0.5 ml dose of PCV20 and 0.5 ml dose of 2.2 mcg VAX-24 in people with Pneumococcal Vaccines, run by Vaxcyte, Inc. at 32 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 7 inclusion and 14 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 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Percentage of participants with any solicited local injection site Adverse Events (AE) within 7 days after each vaccination (time frame: 7 days after each vaccination). 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?
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 11 Sep 2025.