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Meningococcal ImmunizationPhase 1/2NCT06647407

Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants

A Phase 1/2 study testing Pentavalent Meningococcal ABCYW vaccine, MenACYW conjugate vaccine and Meningococcal group B vaccine in people with Meningococcal Immunization and Healthy Volunteers, run by Sanofi Pasteur, a Sanofi Company at 39 sites in 9 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study is the first study of Sanofi's Pentavalent Meningococcal ABCYW vaccine clinical development program to be conducted in the pediatric population below 10 years of age. The aim of the study is to assess 2 formulations of the MenPenta vaccine compared to licensed meningococcal vaccines when administered alone… Read more about this study

Who is it for?
Ages 56 days to 9 yearsHealthy volunteers can take part
What is being tested?
Pentavalent Meningococcal ABCYW vaccine, MenACYW conjugate vaccine and Meningococcal group B vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
750 participants
Where
39 sitesin 9 countries
Study dates
5 Nov 2024to 17 May 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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 56 days to 9 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Aged 2 to 9 years (Stage 1) or 12 to 15 months (Stage 2) or 56 to 89 days (Stage 3) on the day of inclusion
  • For infants and toddlers, born at full term of pregnancy (≥37 weeks) and with a birth weight ≥ 2.5 Kg or born after a gestation period of period above 28 (> 28 weeks) through 36 weeks with a birth weight ≥ 1.5 Kg and in both cases medically stable as assessed by the investigator, based on the following definition: "Medically stable" refers to the condition of premature infants who do not require significant medical support or ongoing management for debilitating disease and who have demonstrated a clinical course of sustained recovery by the time they receive the first dose of study intervention
  • Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and judgement of the investigator

Who cannot join

  • Participants are excluded from the study if any of the following criteria apply:
  • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months or since birth for infants; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months or since birth for and infants)
  • History of any meningitis infection, confirmed either clinically, serologically, or microbiologically
  • At high risk of meningococcal infection during the study
  • Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances
  • Individual with active tuberculosis
Show all 11Show fewer
  • History of Guillain-Barré syndrome
  • For Stage 3 infants: History of intussusception
  • Previous vaccination against meningococcal serogroups A, B, C, W, and/or Y with an investigational or marketed vaccine
  • For Stage 3 infants: receipt of the first dose of rotavirus vaccine less than 28 days before the first trial vaccination
  • NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial locations and contacts

39 sites in 9 countries.

39 sites in 9 countries

Finland7 sites

  • Investigational Site Number : 2460006

    Espoo, 02230

  • Investigational Site Number : 2460001

    Helsinki, 00100

  • Investigational Site Number : 2460008

    Helsinki, 00290

  • Investigational Site Number : 2460005

    Jarvenpaa, 04400

  • Investigational Site Number : 2460004

    Oulu, 90220

  • Investigational Site Number : 2460002

    Seinäjoki, 60100

  • Investigational Site Number : 2460007

    Tampere, 33100

Other trials in Finland

Germany7 sites

  • Investigational Site Number : 2760008

    Herxheim, 76863

  • Investigational Site Number : 2760006

    Hürth, 50354

  • Investigational Site Number : 2760007

    Hürth, 50354

  • Investigational Site Number : 2760005

    Krefeld, 47799

  • Investigational Site Number : 2760009

    Mönchengladbach, 41236

  • Investigational Site Number : 2760004

    Schönau am Königssee, 83471

  • Investigational Site Number : 2760003

    Wolfsburg, 38448

Other trials in Germany

Poland6 sites

  • Investigational Site Number : 6160006

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-090

  • Investigational Site Number : 6160001

    Lodz, Lódzkie, 91-347

  • Investigational Site Number : 6160004

    Siemianowice Śląskie, Silesian Voivodeship, 41-103

  • Investigational Site Number : 6160005

    Trzebnica, Lower Silesian Voivodeship, 55-100

  • Investigational Site Number : 6160003

    Warsaw, Masovian Voivodeship, 02-647

  • Investigational Site Number : 6160002

    Warsaw, Masovian Voivodeship, 02-793

Other trials in Poland

Czechia5 sites

  • Investigational Site Number : 2030003

    Jindřichův Hradec, 377 01

  • Investigational Site Number : 2030004

    Ostrava, 700 30

  • Investigational Site Number : 2030007

    Pilsen, 301 00

  • Investigational Site Number : 2030008

    Prague, 180 00

  • Investigational Site Number : 2030009

    Prague, 180 00

Other trials in Czechia

United Kingdom4 sites

  • Investigational Site Number : 8260004

    Exeter, Devon, EX2 5DW

  • Investigational Site Number : 8260007

    London, England, E1 1BB

  • Investigational Site Number : 8260009

    London, England, SW17 0QT

  • Investigational Site Number : 8260010

    Southampton, Hampshire, SO16 6YD

Other trials in United Kingdom

Honduras3 sites

  • Investigational Site Number : 3400001

    San Pedro Sula

  • Investigational Site Number : 3400002

    Tegucigalpa, 11101

  • Investigational Site Number : 3400003

    Tegucigalpa, 11101

Other trials in Honduras

Spain3 sites

  • Investigational Site Number : 7240009

    Madrid, 28041

  • Investigational Site Number : 7240004

    Madrid, 28938

  • Investigational Site Number : 7240007

    Seville, Sevilla, 41013

Other trials in Spain

Brazil2 sites

  • Hospital das Clínicas da Universidade Federal de Minas Gerais- Site Number : 0760001

    Belo Horizonte, Minas Gerais, 30130-100

  • Private Practice - Dr. Nelson Rosário- Site Number : 0760004

    Curitiba, Paraná, 80810-100

Other trials in Brazil

Denmark2 sites

  • Investigational Site Number : 2080002

    Hvidovre, 2650

  • Investigational Site Number : 2080003

    Odense, 5000

Other trials in Denmark

About this study

Official title: A Parallel-group Prevention, Phase II, Partially Blinded, Multi-stage Study to Investigate the Immunogenicity and Safety of Pentavalent Meningococcal ABCYW Vaccine Formulations Compared With Licensed Meningococcal Vaccines When Administered Alone in Healthy Children (2 to 9 Years of Age) or Concomitantly With Routine Pediatric Vaccines in Toddlers (12 to 15 Months of Age) and Infants (2 Months of Age).

This study is the first study of Sanofi's Pentavalent Meningococcal ABCYW vaccine clinical development program to be conducted in the pediatric population below 10 years of age. The aim of the study is to assess 2 formulations of the MenPenta vaccine compared to licensed meningococcal vaccines when administered alone in children (Stage 1) or concomitantly with routine pediatric vaccines in toddlers (Stage 2) and infants (Stage 3).

Study details include:

The study duration per participant will be up to 12 months for children in Stage 1 and toddlers in Stage 2 and 16 to-19 months for infants in Stage 3.

Being tested
Pentavalent Meningococcal ABCYW vaccine, MenACYW conjugate vaccine, Meningococcal group B vaccine, Paracetamol, DTap-HepB-IPV-Hib vaccine

What participants receive

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

  • Pentavalent Meningococcal ABCYW vaccineBiological

    Also called MenPenta

    Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)

  • MenACYW conjugate vaccineBiological

    Also called MenQuadfi®

    Pharmaceutical form: Solution for injection in vial Route of administration: Intramuscular (IM)

  • MenACYW conjugate vaccineBiological

    Also called Nimenrix®

    Pharmaceutical form: Powder and solvent for injectable solution in a pre-filled syringe Route of administration: Intramuscular (IM)

  • Meningococcal group B vaccineBiological

    Also called Bexsero®

    Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)

  • ParacetamolDrug

    Pharmaceutical form:Suspension-Route of administration:oral

  • DTap-HepB-IPV-Hib vaccineBiological

    Also called Hexyon®

    Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)

  • DTap-HepB-IPV-Hib vaccineBiological

    Also called Vaxelis®

    Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)

  • DTap-HepB-IPV-Hib vaccineBiological

    Also called Infanrix hexa®

    Pharmaceutical form: Oral solution in tube Route of administration: oral

  • Rotavirus vaccineBiological

    Also called RotaTeq® Rotarix®

    Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)

  • Pneumococcal 13-valent conjugate vaccineBiological

    Also called Prevnar 13®

    Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)

Study groups in NCT06647407
Study groupRoleWhat they receive
Stage 1: MenPenta vaccine formulation 1ExperimentalMenPenta vaccine formulation 1, children 2-9 years of age
Receives: Biological: Pentavalent Meningococcal ABCYW vaccine
Stage 1: MenPenta vaccine formulation 2ExperimentalMenPenta vaccine formulation 2, children 2-9 years of age
Receives: Biological: Pentavalent Meningococcal ABCYW vaccine
Stage 1: vaccine comparator(s)Active comparatorComparator vaccines: Bexsero + MenQuadfi, children 2-9 years of age
Receives: Biological: MenACYW conjugate vaccine; Biological: Meningococcal group B vaccine
Stage 2: MenPenta vaccine formulation 1ExperimentalMenPenta vaccine formulation 1 + routine vaccines, toddlers 12-15 months of age
Receives: Biological: Pentavalent Meningococcal ABCYW vaccine; Drug: Paracetamol; Biological: DTap-HepB-IPV-Hib vaccine; Biological: Pneumococcal 13-valent conjugate vaccine
Stage 2: MenPenta vaccine formulation 2ExperimentalMenPenta vaccine formulation 2 + routine vaccines, toddlers 12-15 months of age
Receives: Biological: Pentavalent Meningococcal ABCYW vaccine; Drug: Paracetamol; Biological: DTap-HepB-IPV-Hib vaccine; Biological: Pneumococcal 13-valent conjugate vaccine
Stage 2: vaccine comparator(s)Active comparatorComparator vaccines: Bexsero + MenQuadfi + routine vaccines, toddlers 12-15 months of age
Receives: Biological: MenACYW conjugate vaccine; Biological: Meningococcal group B vaccine; Drug: Paracetamol; Biological: DTap-HepB-IPV-Hib vaccine; Biological: Pneumococcal 13-valent conjugate vaccine
Stage 3: MenPenta vaccine formulation 1ExperimentalMenPenta vaccine formulation 1 + routine vaccines, infants approximately 2 months of age
Receives: Biological: Pentavalent Meningococcal ABCYW vaccine; Drug: Paracetamol; Biological: DTap-HepB-IPV-Hib vaccine; Biological: Rotavirus vaccine; Biological: Pneumococcal 13-valent conjugate vaccine
Stage 3: MenPenta vaccine formulation 2ExperimentalMenPenta vaccine formulation 2 + routine vaccines, infants approximately 2 months of age
Receives: Biological: Pentavalent Meningococcal ABCYW vaccine; Drug: Paracetamol; Biological: DTap-HepB-IPV-Hib vaccine; Biological: Rotavirus vaccine; Biological: Pneumococcal 13-valent conjugate vaccine
Stage 3: vaccine comparator(s)Active comparatorComparator vaccines: Bexsero + Nimenrix + routine vaccines, infants approximately 2 months of age
Receives: Biological: MenACYW conjugate vaccine; Biological: Meningococcal group B vaccine; Drug: Paracetamol; Biological: DTap-HepB-IPV-Hib vaccine; Biological: Rotavirus vaccine; Biological: Pneumococcal 13-valent conjugate vaccine

What is being measured

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

  1. Number of participants with unsolicited immediate adverse events (AEs)

    Unsolicited systemic AEs that occur within 30 minutes after vaccination

    Measured: Within 30 minutes after each vaccination

  2. Number of participants with solicited injection site reactions or systemic reactions

    Pre-defined solicited injection site reactions and systemic reactions that are pre-listed in the diary cards and CRF

    Measured: Within 7 days after each vaccination

  3. Number of participants with unsolicited AEs

    Unsolicited AEs other than solicited reactions

    Measured: Within 30 days after each vaccination

  4. Number of participants with serious adverse events (SAEs)

    SAEs (including adverse events of special interest [AESIs]) reported throughout the study

    Measured: Throughout the study, from first visit until 180 days after the last vaccination

  5. hSBA meningococcal serogroups A, C, W, and Y antibody titers pre-dose and 30 days after the second and third dose in infant participants

    hSBA titers ≥ 1:8 post-vaccination (post-second and third dose)

    Measured: For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391

  6. hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse pre-dose and 1 month after the second and third dose in infant participants

    Seroresponse defined as post-vaccination titers ≥ 1:16 for participants with pre-vaccination hSBA titers < 1:4 or or postvaccination titers ≥ 4 times the lower limit of quantification (LLOQ) for participants with a pre-vaccination titer ≤ LLOQ or a post-vaccination titer ≥ 4 times the pre-vaccination titer for participants with a pre-vaccination titer ≥ LLOQ

    Measured: For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391

  7. Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroups A, C, W and Y pre-dose and 1 month after the second and third dose in infant participants

    Geometric mean titers (pre-dose and post-second and third dose)

    Measured: For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391

  8. Percentage of participants with hSBA titers more or equal to lower limit of quantification (LLOQ) against each of serogroups A, C, W, and Y pre-dose and 1 month after the second and third dose in infant participants

    Measured: For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391

  9. Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:4 pre-dose and 1 month after second dose of vaccination against serogroup B, before and 30 days after third dose in infants

    hSBA titers ≥ 1:4 for reference MenB strains

    Measured: For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391

  10. Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:8 pre-dose and 1 month after the second dose of vaccination against serogroup B, before and 30 days after third dose in infants

    hSBA titers ≥ 1:8 for reference MenB strains

    Measured: For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391

  11. hSBA meningococcal serogroup B seroresponse pre-dose and 1 month after the second dose of vaccination against serogroup B, before and 30 days after third dose in infant participants

    Seroresponse defined as a 4-fold increase in hSBA titers

    Measured: For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391

  12. Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference MenB strains) pre-dose and 1 month after the second dose of vaccination against serogroup B, before and 30 days after third dose in infant participants

    Geometric mean titers (pre-dose and post-second dose) for the reference MenB strains

    Measured: Day 01, Day 91, Day 181 and Day 211 (for Stage 3)

  13. Percentage of participants with hSBA titers more or equal to lower limit of quantification (LLOQ) against each and all of serogroup B (ref. MenB strains) predose and 1 month after 2nd dose against serogroup B, before and 30 days after 3rd dose in infants

    Measured: For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391

  14. Percentage of participants with hSBA titers less than LLOQ against all serogroup B (ref. MenB strains) pre-dose and 1 month after the 2nd dose of vaccination against serogroup B, before and 30 days after 3rd dose in infants

    Measured: For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391

  15. hSBA meningococcal serogroups A, C, W, and Y antibody titers in children and toddlers

    hSBA titers ≥ 1:8 for serogroups A, C, W, and Y

    Measured: For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211

  16. hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse in children and toddlers

    Seroresponse defined as post-vaccination titers ≥ 1:16 for participants with pre-vaccination hSBA titers < 1:4 or or postvaccination titers ≥ 4 times the lower limit of quantification (LLOQ) for participants with a pre-vaccination titer ≤ LLOQ or a post-vaccination titer ≥ 4 times the pre-vaccination titer for participants with a pre-vaccination titer ≥ LLOQ

    Measured: For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211

  17. Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroups A, C, W and Y pre-dose and 1 month after the second dose children and toddlers

    Measured: For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211

  18. Percentage of participants with hSBA titers more or equal to lower limit of quantification (LLOQ) against each of serogroups A, C, W, and Y children and toddlers

    Measured: For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211

  19. Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:4 in children and toddlers

    Measured: For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211

  20. Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:8 in children and toddlers

    Measured: For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211

  21. hSBA meningococcal serogroup B (reference MenB strains) vaccine seroresponse in children and toddlers

    Seroresponse defined as a 4-fold increase in hSBA titers

    Measured: For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211

  22. Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference MenB strains) in children and toddlers

    Measured: For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211

  23. Percentage of participants with hSBA titers more or equal to lower limit of quantification (LLOQ) against each and all of serogroup B (reference MenB strains) in children and toddlers

    Measured: For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211

  24. Percentage of participants with hSBA titers less than the lower limit of quantification (LLOQ) against all serogroup B (reference MenB strains) in children and toddlers

    Measured: For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211

Secondary outcomes (6)

  1. hSBA meningococcal serogroup B (additional MenB strains) vaccine seroresponse in children, toddler and infant participants

    Measured: Stage 1 and 2: Day 1 and Day 211. Stage 3: Day 1, Day 331-391

  2. Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (additional MenB strains) ≥ 1:4 in children, toddler and infant participants

    hSBA titers ≥ 1:4 for additional MenB strains

    Measured: Stage 1 and 2: Day 1 and Day 211. Stage 3: Day 1, Day 331-391

  3. Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (additional MenB strains) ≥ 1:8 in children, toddler and infant participants

    hSBA titers ≥ 1:8 for additional MenB strains

    Measured: Stage 1 and 2: Day 1 and Day 211. Stage 3: Day 1, Day 331-391

  4. Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (additional MenB strains) in children, toddler and infant participants

    Measured: Stage 1 and 2: Day 1 and Day 211. Stage 3: Day 1, Day 331-391

  5. Percentage of participants with hSBA composite seroresponse titers more or equal to LLOQ each and all additional MenB strains in children, toddler and infant participants

    Measured: Stage 1 and 2: Day 1 and Day 211. Stage 3: Day 1, Day 331-391

  6. Percentage of participants with hSBA composite seroresponse titers less than LLOQ all additional MenB strains in children, toddler and infant participants

    Measured: Stage 1 and 2: Day 1 and Day 211. Stage 3: Day 1, Day 331-391

Timeline

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

  1. First posted17 Oct 2024
  2. Study start5 Nov 2024
  3. Primary completion17 May 2027 (estimated)
  4. Study completion17 May 2027 (estimated)

Resources

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 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
750 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06647407
Sponsor's protocol ID
VAN00013
Other IDs
2023-510465-10, 2023
Status last verified
Jan 2026
First submitted
16 Oct 2024
Last updated
20 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Pentavalent Meningococcal ABCYW vaccine, MenACYW conjugate vaccine and Meningococcal group B vaccine in people with Meningococcal Immunization and Healthy Volunteers, run by Sanofi Pasteur, a Sanofi Company at 39 sites in 9 countries.

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 11 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: under way, not looking for participants, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in Finland, Germany, Poland, Czechia, United Kingdom and 4 more countries. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with unsolicited immediate adverse events (AEs) (time frame: Within 30 minutes after each vaccination). The study lists 24 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 NCT06647407.

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 20 Jan 2026.

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