SplenectomyPhase 3SPLEMENGONCT04166656
Research Trial Assessing the Immunogenicity and Safety of Three Meningococcal B Vaccine Strategies Among Patients With Asplenia.
A Phase 3 study testing Trumenba® and Bexsero® in people with Splenectomy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of the study is to evaluate the immunological response and tolerance of 3 vaccine strategies against meningococcus B, a potentially fatal invasive infection. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Splenectomy
- What is being tested?
- Trumenba® and Bexsero®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2022to Oct 2028
- Phase
- Phase 3
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, >=18 to <=75 years old.
- Asplenic patient (for at least 2 weeks) with Howell Jolly bodies visible on blood film
- Splenectomy confirmed by consultation and/or hospitalization report or the ultrasound if it has been performed during the routine follow-up
- Women of childbearing age must have an effective contraception during the first 9 months of the study.
- Participants must give written consent prior to any trial procedure
- Participants must be covered by social security regimen or equivalent.
- Participants will be followed during the 4 years from the inclusion visit.
Who cannot join
- History of meningococcal vaccination B.
- History of anaphylaxis post vaccination.
- Known allergy to any components (active substances or excipients) of both vaccines.
- Patients who cannot stop antibiotics 3 days before blood collection.
- Participants who have received any another vaccines within 4 weeks prior to immunization or who are planning to receive any vaccine within the first 7 months of the study (except the meningococcal ACWY vaccine, the anti-pneumococcal vaccine, the Haemophilus influenzae type B vaccine, the anti-Covid-19 vaccine), annual influenza vaccination which is permitted 2 weeks before and after each vaccination visit of the study and then allowed at any time during the study follow up).
- Parenteral Ig within the 3 months prior to VS or planned during the study.
Show all 13Show fewer
- Chemotherapy agents within 6 months prior M0 or planning to take any during the study.
- Steroids (> 10mg/day; > 14 days) within the month preceding M0 or planning to take any during the study.
- Any pathology or condition that may impair the immune response, apart from splenectomy: immunosuppressive therapy in progress or in the 6 months prior to inclusion, hematopoietic stem cells allo / autograft, primary immunodeficiency, nephrotic syndrome, evolutive cancer, cirrhosis, known infection to HIV;
- Thrombocytopenia or any coagulation disorder contra-indicating intramuscularly injections.
- Pregnancy, breastfeeding or positive pregnancy test up to 7 months after inclusion.
- Severe acute febrile illness within the week before inclusion.
- Registration for any other clinical trial throughout the trial period except observational study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
I-REIVAC/CIC1417 Cochin Hospital, AP-HP
Paris, 75014
Odile LAUNAY, MD,PhD, +33(01)58 41 28 58, odile.launay@aphp.fr
Mouna Fellague Chebra, project manager, +33 (0)1 58 41 33 54, mouna.fellaguechebra@aphp.fr
About this study
Official title: Multicenter, Randomized, Phase III, Trial Assessing the Immunogenicity and Safety of Three Meningococcal B Vaccine Strategies Among Patients With Asplenia
The purpose of the study is to evaluate the immunological response and tolerance of 3 vaccine strategies against meningococcus B, a potentially fatal invasive infection.
Read the detailed description
Currently, in France, no immunogenicity data on Meningococcal B vaccines, neither with Bexsero® nor with Trumenba®, are available in asplenic patients, population at high risk of infection.
As asplenic individuals (all causes) show less optimal immune response to conjugate meningococcal C vaccine compared to matched controls. [4], we hypothesize that a similar less optimal response may be expected for MenB vaccines among asplenic subjects. .
That is why, we proposed in this study to evaluate two reinforced strategies with 3 administrations (M0, M1, and M6) of Bexsero® or Trumenba ®. Moreover, the study will also allow exploring the persistence of the immune response in this population. Indeed, few data are available on this persistence in the general population.
- Conditions
- Splenectomy
- Being tested
- Trumenba®, Bexsero®
- Keywords
- Meningococcal B vaccine, vaccine strategies, splenectomized individuals
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trumenba®Biological
Trumenba® (Pfizer): Suspension for intramuscular injection in 0.5 mL single-dose prefilled.
Bexsero®Biological
Bexsero® (GSK): available as a suspension for intramuscular injection in a prefilled syringe
| Study group | Role | What they receive |
|---|---|---|
| Arm A : Trumenba®: Standard vaccination | Other | Two doses of 0.5 ml each at one month intervals, followed by a third dose given at 6 months after the second dose. Receives: Biological: Trumenba® |
| Arm B:Bexsero®: standard vaccination regimen | Other | Two doses of 0.5 ml each at one month intervals Receives: Biological: Bexsero® |
| Arm C : Bexsero® Innovative vaccine strategy | Other | Two doses of 0.5 ml each at one month intervals, followed by a third dose given at 6 months after the second dose. Receives: Biological: Bexsero® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of responders defined as participants with seroconversion
Proportion of responders defined as participants with seroconversion (i.e. hSBA titer increases from <4 before vaccination to at least 4) or with hSBA titer showing a 4-fold increase (if hSBA titer was at least 4 before vaccination) one month after the completeness of three anti-meningococci B vaccine strategies (at M7 for all arms) in asplenic adults.
Measured: One month after the completeness of three anti-meningococci B vaccine strategies (at M7 for all arms) in asplenic adults.
Secondary outcomes (5)
Immunogenicity
Immunogenicity at M2/M7, i.e. one month after the completeness of each vaccine strategy:
- Serum bactericidal antibody (hSBA) Geometric Mean Titer (GMT).
- Proportion of responding participants using the conservative threshold of 8.
- Proportion of participants achieving an hSBA titer equal to or greater than the lower limit of quantification of the assay.
Measured: one month after the completeness of each vaccine strategy
Persistence of immunogenicity
Persistence of immunogenicity at M12 M24, M36 and M48 for each vaccine strategy
- Serum bactericidal antibody (hSBA), GMT.
- Proportion of responding participants using the conservative threshold of 8.
- Proportion of participants achieving an SBA titre equal to or greater than the lower limit of quantification of the assay.
Measured: At M12 M24, M36 and M48
Modeling of the determinants of immunogenicity
Modeling of the determinants of immunogenicity: reason for splenectomy, age, gender, immunosuppressive or immunomodulatory agent
Measured: during the trial
Any event or serious adverse event
Any event or serious adverse event during the trial possibly or not related to vaccine immunization.
Measured: 7 days following each vaccination.
safety and effectiveness
To assess safety and effectiveness of Bexsero® and Trumenba® in asplenic adults older than 65 years of age.
Measured: through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start15 Sep 2022
- Primary completionSep 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for SplenectomyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- EUCLID Clinical Trial Platform, Recherche Clinique Paris Descartes Necker Cochin Sainte Anne, CIC 1417 Cochin-Pasteur, Innovative clinical research in vaccinologie (I-REIVAC), Institut Pasteur, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Odile LAUNAY, MD,PhD, Principal investigator, CIC 1417 Clinical Center InvestigationMUHAMED-KHEIR TAHA, MD, PHD, Study director, Institut Pasteur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04166656
- Sponsor's protocol ID
- P170938J
- Other IDs
- 2019-000924-17, 2019
- Acronym
- SPLEMENGO
- Status last verified
- Oct 2025
- First submitted
- 29 Aug 2019
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Borrow R. Advances with vaccination against Neisseria meningitidis. Trop Med Int Health. 2012 Dec;17(12):1478-91. doi: 10.1111/j.1365-3156.2012.03085.x. Epub 2012 Sep 4.
PubMed 22947250Frosi G, Biolchi A, Lo Sapio M, Rigat F, Gilchrist S, Lucidarme J, Findlow J, Borrow R, Pizza M, Giuliani MM, Medini D. Bactericidal antibody against a representative epidemiological meningococcal serogroup B panel confirms that MATS underestimates 4CMenB vaccine strain coverage. Vaccine. 2013 Oct 9;31(43):4968-74. doi: 10.1016/j.vaccine.2013.08.006. Epub 2013 Aug 14.
PubMed 23954380Murphy E, Andrew L, Lee KL, Dilts DA, Nunez L, Fink PS, Ambrose K, Borrow R, Findlow J, Taha MK, Deghmane AE, Kriz P, Musilek M, Kalmusova J, Caugant DA, Alvestad T, Mayer LW, Sacchi CT, Wang X, Martin D, von Gottberg A, du Plessis M, Klugman KP, Anderson AS, Jansen KU, Zlotnick GW, Hoiseth SK. Sequence diversity of the factor H binding protein vaccine candidate in epidemiologically relevant strains of serogroup B Neisseria meningitidis. J Infect Dis. 2009 Aug 1;200(3):379-89. doi: 10.1086/600141.
PubMed 19534597Balmer P, Falconer M, McDonald P, Andrews N, Fuller E, Riley C, Kaczmarski E, Borrow R. Immune response to meningococcal serogroup C conjugate vaccine in asplenic individuals. Infect Immun. 2004 Jan;72(1):332-7. doi: 10.1128/IAI.72.1.332-337.2004.
PubMed 146881125. Hcsp. Avis du hcsp relatif à l'utilisation du vaccin bexsero® (novartis vaccines and diagnostics). 2013. (link:http://www.hcsp.fr/explore.cgi/telecharger?nomfichier=hcspa20131025_vaccmeningocoquebbexsero®.pdf.
McQuaid F, Snape MD, John TM, Kelly S, Robinson H, Houlden J, Voysey M, Toneatto D, Kitte C, Dull PM, Pollard AJ. Persistence of bactericidal antibodies to 5 years of age after immunization with serogroup B meningococcal vaccines at 6, 8, 12 and 40 months of age. Pediatr Infect Dis J. 2014 Jul;33(7):760-6. doi: 10.1097/INF.0000000000000327.
PubMed 24722351Wasserstrom H, Bussel J, Lim LC, Cunningham-Rundles C. Memory B cells and pneumococcal antibody after splenectomy. J Immunol. 2008 Sep 1;181(5):3684-9. doi: 10.4049/jimmunol.181.5.3684.
PubMed 18714044Mori M, Morris SC, Orekhova T, Marinaro M, Giannini E, Finkelman FD. IL-4 promotes the migration of circulating B cells to the spleen and increases splenic B cell survival. J Immunol. 2000 Jun 1;164(11):5704-12. doi: 10.4049/jimmunol.164.11.5704.
PubMed 10820247Sullivan JL, Ochs HD, Schiffman G, Hammerschlag MR, Miser J, Vichinsky E, Wedgwood RJ. Immune response after splenectomy. Lancet. 1978 Jan 28;1(8057):178-81. doi: 10.1016/s0140-6736(78)90612-8.
PubMed 74605Goldschneider I, Gotschlich EC, Artenstein MS. Human immunity to the meningococcus. I. The role of humoral antibodies. J Exp Med. 1969 Jun 1;129(6):1307-26. doi: 10.1084/jem.129.6.1307.
PubMed 4977280
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Phase III, Trial Assessing the Immunogenicity and Safety of Three Meningococcal B Vaccine Strategies Among Patients With Asplenia
- ClinicalTrials.gov ID
- NCT04166656
- Acronym / sponsor ID
- SPLEMENGO / P170938J
- Conditions
- Splenectomy
- Keywords
- Meningococcal B vaccine, vaccine strategies, splenectomized individuals
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- EUCLID Clinical Trial Platform, Recherche Clinique Paris Descartes Necker Cochin Sainte Anne, CIC 1417 Cochin-Pasteur, Innovative clinical research in vaccinologie (I-REIVAC), Institut Pasteur, URC-CIC Paris Descartes Necker Cochin
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 18 Nov 2019 (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 purpose of the study is to evaluate the immunological response and tolerance of 3 vaccine strategies against meningococcus B, a potentially fatal invasive infection.
Detailed description
Currently, in France, no immunogenicity data on Meningococcal B vaccines, neither with Bexsero® nor with Trumenba®, are available in asplenic patients, population at high risk of infection.
As asplenic individuals (all causes) show less optimal immune response to conjugate meningococcal C vaccine compared to matched controls. [4], we hypothesize that a similar less optimal response may be expected for MenB vaccines among asplenic subjects. .
That is why, we proposed in this study to evaluate two reinforced strategies with 3 administrations (M0, M1, and M6) of Bexsero® or Trumenba ®. Moreover, the study will also allow exploring the persistence of the immune response in this population. Indeed, few data are available on this persistence in the general population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A : Trumenba®: Standard vaccination | Other | Biological: Trumenba®Two doses of 0.5 ml each at one month intervals, followed by a third dose given at 6 months after the second dose. |
| Arm B:Bexsero®: standard vaccination regimen | Other | Biological: Bexsero®Two doses of 0.5 ml each at one month intervals |
| Arm C : Bexsero® Innovative vaccine strategy | Other | Biological: Bexsero®Two doses of 0.5 ml each at one month intervals, followed by a third dose given at 6 months after the second dose. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female, >=18 to <=75 years old.
- Asplenic patient (for at least 2 weeks) with Howell Jolly bodies visible on blood film
- Splenectomy confirmed by consultation and/or hospitalization report or the ultrasound if it has been performed during the routine follow-up
- Women of childbearing age must have an effective contraception during the first 9 months of the study.
- Participants must give written consent prior to any trial procedure
Key exclusion criteria (13 listed)
- History of meningococcal vaccination B.
- History of anaphylaxis post vaccination.
- Known allergy to any components (active substances or excipients) of both vaccines.
- Patients who cannot stop antibiotics 3 days before blood collection.
- Participants who have received any another vaccines within 4 weeks prior to immunization or who are planning to receive any vaccine within the first 7 months of the study (except the meningococcal ACWY vaccine, the anti-pneumococcal vaccine, the Haemophilus influenzae type B vaccine, the anti-Covid-19 vaccine), annual influenza vaccination which is permitted 2 weeks before and after each vaccination visit of the study and then allowed at any time during the study follow up).
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 |
|---|---|---|
| Trumenba®Trumenba® (Pfizer): Suspension for intramuscular injection in 0.5 mL single-dose prefilled. | Biological | Arm A : Trumenba®: Standard vaccination |
| Bexsero®Bexsero® (GSK): available as a suspension for intramuscular injection in a prefilled syringe | Biological | Arm B:Bexsero®: standard vaccination regimen, Arm C : Bexsero® Innovative vaccine strategy |
Primary outcome
Proportion of responders defined as participants with seroconversion
Time frame: One month after the completeness of three anti-meningococci B vaccine strategies (at M7 for all arms) in asplenic adults.
Proportion of responders defined as participants with seroconversion (i.e. hSBA titer increases from <4 before vaccination to at least 4) or with hSBA titer showing a 4-fold increase (if hSBA titer was at least 4 before vaccination) one month after the completeness of three anti-meningococci B vaccine strategies (at M7 for all arms) in asplenic adults.
5 secondary outcomes
Immunogenicity
Time frame: one month after the completeness of each vaccine strategy
Persistence of immunogenicity
Time frame: At M12 M24, M36 and M48
Modeling of the determinants of immunogenicity
Time frame: during the trial
Any event or serious adverse event
Time frame: 7 days following each vaccination.
safety and effectiveness
Time frame: through study completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Background: PubMed 22947250Borrow R. Advances with vaccination against Neisseria meningitidis. Trop Med Int Health. 2012 Dec;17(12):1478-91. doi: 10.1111/j.1365-3156.2012.03085.x. Epub 2012 Sep 4.
- Background: PubMed 23954380Frosi G, Biolchi A, Lo Sapio M, Rigat F, Gilchrist S, Lucidarme J, Findlow J, Borrow R, Pizza M, Giuliani MM, Medini D. Bactericidal antibody against a representative epidemiological meningococcal serogroup B panel confirms that MATS underestimates 4CMenB vaccine strain coverage. Vaccine. 2013 Oct 9;31(43):4968-74. doi: 10.1016/j.vaccine.2013.08.006. Epub 2013 Aug 14.
- Background: PubMed 19534597Murphy E, Andrew L, Lee KL, Dilts DA, Nunez L, Fink PS, Ambrose K, Borrow R, Findlow J, Taha MK, Deghmane AE, Kriz P, Musilek M, Kalmusova J, Caugant DA, Alvestad T, Mayer LW, Sacchi CT, Wang X, Martin D, von Gottberg A, du Plessis M, Klugman KP, Anderson AS, Jansen KU, Zlotnick GW, Hoiseth SK. Sequence diversity of the factor H binding protein vaccine candidate in epidemiologically relevant strains of serogroup B Neisseria meningitidis. J Infect Dis. 2009 Aug 1;200(3):379-89. doi: 10.1086/600141.
- Background: PubMed 14688112Balmer P, Falconer M, McDonald P, Andrews N, Fuller E, Riley C, Kaczmarski E, Borrow R. Immune response to meningococcal serogroup C conjugate vaccine in asplenic individuals. Infect Immun. 2004 Jan;72(1):332-7. doi: 10.1128/IAI.72.1.332-337.2004.
- Background5. Hcsp. Avis du hcsp relatif à l'utilisation du vaccin bexsero® (novartis vaccines and diagnostics). 2013. (link:http://www.hcsp.fr/explore.cgi/telecharger?nomfichier=hcspa20131025_vaccmeningocoquebbexsero®.pdf.
- Background: PubMed 24722351McQuaid F, Snape MD, John TM, Kelly S, Robinson H, Houlden J, Voysey M, Toneatto D, Kitte C, Dull PM, Pollard AJ. Persistence of bactericidal antibodies to 5 years of age after immunization with serogroup B meningococcal vaccines at 6, 8, 12 and 40 months of age. Pediatr Infect Dis J. 2014 Jul;33(7):760-6. doi: 10.1097/INF.0000000000000327.
- Background: PubMed 18714044Wasserstrom H, Bussel J, Lim LC, Cunningham-Rundles C. Memory B cells and pneumococcal antibody after splenectomy. J Immunol. 2008 Sep 1;181(5):3684-9. doi: 10.4049/jimmunol.181.5.3684.
- Background: PubMed 10820247Mori M, Morris SC, Orekhova T, Marinaro M, Giannini E, Finkelman FD. IL-4 promotes the migration of circulating B cells to the spleen and increases splenic B cell survival. J Immunol. 2000 Jun 1;164(11):5704-12. doi: 10.4049/jimmunol.164.11.5704.
- Background: PubMed 74605Sullivan JL, Ochs HD, Schiffman G, Hammerschlag MR, Miser J, Vichinsky E, Wedgwood RJ. Immune response after splenectomy. Lancet. 1978 Jan 28;1(8057):178-81. doi: 10.1016/s0140-6736(78)90612-8.
- Background: PubMed 4977280Goldschneider I, Gotschlich EC, Artenstein MS. Human immunity to the meningococcus. I. The role of humoral antibodies. J Exp Med. 1969 Jun 1;129(6):1307-26. doi: 10.1084/jem.129.6.1307.
- Individual participant dataSharing planned: Undecided
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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.
Odile LAUNAY, MD,PhD principal investigator
CIC 1417 Clinical Center Investigation
MUHAMED-KHEIR TAHA, MD, PHD study director
Institut Pasteur
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Trumenba® and Bexsero® in people with Splenectomy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 13 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: looking for participants now, as of the sponsor's last update on 20 Nov 2025. 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 France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Odile LAUNAY, MD,PhD (+33(01)58 41 28 58, odile.launay@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of responders defined as participants with seroconversion (time frame: One month after the completeness of three anti-meningococci B vaccine strategies (at M7 for all arms) in asplenic adults.). 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 NCT04166656, which also lists 10 linked publications.
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 Nov 2025.