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Meningococcal Infection (Healthy Volunteers)Phase 3NCT04142242

Study to Assess the Safety and Immunogenicity of a Single Dose of a Quadrivalent Meningococcal (MenACYW) Conjugate Vaccine in Older Adults Who Received a Primary Vaccination (3 or More Years Earlier) in Study MET49

A Phase 3 study testing Meningococcal Polysaccharide (serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine and Blood sample in people with Meningococcal Infection (Healthy Volunteers), run by Sanofi Pasteur, a Sanofi Company at 34 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Primary Objective: To demonstrate sufficiency of the vaccine seroresponse to meningococcal serogroups A, C, W, and Y following administration of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W 135) Tetanus Toxoid (MenACYW) Conjugate vaccine to Group 1 participants (who received primary… Read more about this study

Who is it for?
Ages 59 years and olderHealthy volunteers can take part
What is being tested?
Meningococcal Polysaccharide (serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine and Blood sample
Could I receive a placebo?
No, everyone receives an active treatment
How many people
471 participants
Where
34 sitesin 2 countries
Study dates
4 Oct 2019to 25 May 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 59 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Received primary vaccination in Study MET49 or Study MET44 at >= 56 years of age with either Menomune vaccine or MenACYW Conjugate vaccine, as assigned by randomization. (">= 56 years" means from the day of the 56th birthday onwards).
  • Able to attend all scheduled visits and to comply with all study procedures.

Who cannot join

  • Pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, or surgically sterile.
  • Participation in the 4 weeks preceding study enrollment/vaccination or planned participation during the active phase of the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
  • Note: "Active phase" refers to the period of time from revaccination with MenACYW Conjugate vaccine to the end of the short-term (i.e., ~30 days) follow-up after the vaccination. Accordingly, following the blood draw at Visit 1, participants in Group 3 and Group 4 will have a 2-year inactive phase prior to Visit 2. Prior to Visit 2, participants in Group 3 and Group 4 will have inclusion and exclusion criteria reassessed and will continue with or be excluded from further participation in the trial as appropriate.
  • Receipt of any vaccine in the 4 weeks (28 days) preceding the study vaccination or planned receipt of any vaccine during the active phase of the present study except for influenza vaccination, which might be received at least 2 weeks before or after study vaccine. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
  • Receipt or planned receipt of any meningococcal vaccine since receipt of a single dose of MenACYW Conjugate vaccine or Menomune vaccine in Study MET49 or Study MET44.
  • Receipt of immune globulins, blood, or blood-derived products in the 3 months prior to either enrollment or MenACYW Conjugate vaccination in the current study.
Show all 20Show fewer
  • 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 long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months prior either to enrollment or MenACYW conjugate vaccination in the current study).
  • History of meningococcal infection, confirmed either clinically, serologically, or microbiologically.
  • At high risk for meningococcal infection during the study (specifically, but not limited to, participants with persistent complement deficiency, with anatomic or functional asplenia, or participants travelling to countries with high endemic or epidemic disease).
  • Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the study or to a vaccine containing any of the same substances (excluding participants in Group 5 and Group 6).
  • Verbal report of thrombocytopenia, contraindicating IM vaccination, in the Investigator's opinion (excluding participants in Group 5 and Group 6).
  • Personal history of Guillain-Barré Syndrome (GBS) (excluding participants in Group 5 and Group 6).
  • Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine within at least 10 years of the proposed study vaccination (excluding participants in Group 5 and Group 6).
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion (excluding participants in Group 5 and Group 6), contraindicating IM vaccination in the Investigator's opinion.
  • Current alcohol abuse or drug addiction.
  • Chronic illness that, in the opinion of the Investigator, was at a stage where it might interfere with study conduct or completion.
  • Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature >= 100.4°F). A prospective participant should not be included in the study or receive study vaccination until the condition has resolved or the febrile event has subsided.
  • Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw.
  • Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
  • The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Trial locations and contacts

34 sites in 2 countries.

34 sites in 2 countries

United States33 sites

  • Investigational Site Number 8400018

    Anderson, South Carolina, 29621

  • Investigational Site Number 8400026

    Chandler, Arizona, 85225

  • Investigational Site Number 8400004

    Charlottesville, Virginia, 22911

  • Investigational Site Number 8400035

    Cincinnati, Ohio, 45241

  • Investigational Site Number 8400005

    Cincinnati, Ohio, 45246

  • Investigational Site Number 8400038

    Clearwater, Florida, 33756

  • Investigational Site Number 8400011

    Columbus, Ohio, 43212

  • Investigational Site Number 8400024

    Dallas, Texas, 75231

  • Investigational Site Number 8400023

    DeLand, Florida, 32720

  • Investigational Site Number 8400010

    Elkridge, Maryland, 21075

  • Investigational Site Number 8400019

    Endwell, New York, 13760

  • Investigational Site Number 8400013

    Fargo, North Dakota, 58104

  • Investigational Site Number 8400021

    Greensboro, North Carolina, 27408

  • Investigational Site Number 8400007

    Jacksonville, Florida, 32205

  • Investigational Site Number 8400015

    Jacksonville, Florida, 32216

  • Investigational Site Number 8400016

    Metairie, Louisiana, 70006

  • Investigational Site Number 8400034

    Mt. Pleasant, South Carolina, 29464

  • Investigational Site Number 8400036

    Mt. Pleasant, South Carolina, 29464

  • Investigational Site Number 8400001

    Murray, Utah, 84123

  • Investigational Site Number 8400027

    Newton, Kansas, 67114

  • Investigational Site Number 8400022

    Ponte Vedra, Florida, 32081

  • Investigational Site Number 8400032

    Port Orange, Florida, 32127

  • Investigational Site Number 8400012

    Raleigh, North Carolina, 27612

  • Investigational Site Number 8400031

    Richfield, Minnesota, 55423

  • Investigational Site Number 8400002

    Salt Lake City, Utah, 84107

  • Investigational Site Number 8400003

    San Diego, California, 92123-1881

  • Investigational Site Number 8400030

    St Louis, Missouri, 63141

  • Investigational Site Number 8400014

    Uniontown, Pennsylvania, 15401

  • Investigational Site Number 8400028

    Waterbury, Connecticut, 06708

  • Investigational Site Number 8400025

    West Jordan, Utah, 84088-8865

  • Investigational Site Number 8400020

    West Palm Beach, Florida, 33409

  • Investigational Site Number 8400017

    Wichita, Kansas, 67205

  • Investigational Site Number 8400033

    Winston-Salem, North Carolina, 27103

Other trials in United States

Puerto Rico1 site

  • Investigational Site Number 6300001

    San Juan, 00981

Other trials in Puerto Rico

About this study

Official title: Safety and Immunogenicity of a Single Dose of MenACYW Conjugate Vaccine at Least 3 Years Following Initial Vaccination With Either Menomune® Vaccine or MenACYW Conjugate Vaccine in Older Adults

Primary Objective:

To demonstrate sufficiency of the vaccine seroresponse to meningococcal serogroups A, C, W, and Y following administration of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W 135) Tetanus Toxoid (MenACYW) Conjugate vaccine to Group 1 participants (who received primary vaccination with Menomune vaccine greater than or equal to [>= 3] years earlier at >= 56 years of age in Study MET49).

Read more

Secondary Objectives:

Secondary Objective 1 - To demonstrate sufficiency of the vaccine seroresponse to meningococcal serogroups A, C, W, and Y following administration of a single dose of MenACYW Conjugate vaccine to Group 2 participants (who received primary vaccination with MenACYW Conjugate vaccine >= 3 years earlier at >= 56 years of age in Study MET49).

Secondary Objective 2 - To describe vaccine seroresponse rates with respect to serogroups A, C, W, and Y in serum specimens collected 6 days (window, 5-7) post-vaccination in approximately 60 participants from Group 1 (Menomune-primed) and approximately 60 participants from Group 2 (MenACYW Conjugate vaccine-primed).

Secondary Objective 3 - To describe antibody persistence >= 3 years after primary vaccination with Menomune vaccine or MenACYW Conjugate vaccine for participants from all groups.

Read the detailed description

Study duration per participant in Group 1 and Group 2 was approximately 30 days including: 1 day of screening and vaccination, a phone call and a safety-follow up/end of study visit at Day 8 and Day 30 after vaccine administration, respectively.

Study duration per participant in Group 3 and 4 was approximately 2 years and 30 days including: 1 day of screening, 1 day of vaccination 2 years later, a phone call and a safety-follow up/end of study visit at Day 8 and Day 30 after vaccine administration, respectively.

Study duration per participant in Group 5 and 6 was 1 day.

Safety assessment includes solicited reactions within 7 days after vaccination, unsolicited adverse events (AEs), serious adverse events (SAEs) and adverse event of special interest (AESI)s throughout the study "active phase" (i.e., period of time from revaccination with MenACYW Conjugate vaccine to the end of the short-term [i.e., ~30 days] follow-up after the vaccination).

Being tested
Meningococcal Polysaccharide (serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine, Blood sample
Medical subject headings
Meningococcal Infections

What participants receive

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

  • Meningococcal Polysaccharide (serogroups A, C, Y, and W) Tetanus Toxoid Conjugate VaccineBiological

    Also called MenACYW Conjugate vaccine, MenQuadfi

    Pharmaceutical form: Solution for injection; Route of administration: Intramuscular

  • Blood sampleOther

    Blood sample for assessment of antibody persistence.

Study groups in NCT04142242
Study groupRoleWhat they receive
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)ExperimentalParticipants who received a single dose of Menomune vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment [Day 0]) followed by a single intramuscular (IM) dose of MenACYW Conjugate vaccine, at Day 0, during Stage I in the present study (MEQ00066).
Receives: Biological: Meningococcal Polysaccharide (serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)ExperimentalParticipants who received a single dose of MenACYW Conjugate vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment [Day 0]) followed by a single IM dose of MenACYW Conjugate vaccine at Day 0, during Stage I in the present study (MEQ00066).
Receives: Biological: Meningococcal Polysaccharide (serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
Group 3: MenACYW Conjugate Vaccine (MET49: Menomune-primed Participants)ExperimentalParticipants who received a single dose of Menomune vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066), followed by receiving a single IM dose of MenACYW Conjugate vaccine at Stage II in the present study (MEQ00066).
Receives: Biological: Meningococcal Polysaccharide (serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
Group 4: MenACYW Conjugate Vaccine (MET49: MenACYW-primed Participants)ExperimentalParticipants who received a single dose of MenACYW Conjugate vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066), followed by receiving a single IM dose of MenACYW Conjugate vaccine at Stage II in the present study (MEQ00066).
Receives: Biological: Meningococcal Polysaccharide (serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
Group 5: Menomune-primed Participants (MET44)OtherParticipants who received a single dose of Menomune vaccine in a previous study MET44, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066). These participants did not receive any vaccination in the present study (MEQ00066).
Receives: Other: Blood sample
Group 6: MenACYW Conjugate Vaccine-primed Participants (MET44)OtherParticipants who received a single dose of MenACYW Conjugate vaccine in a previous study MET44, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066). These participants did not receive any vaccination in the present study (MEQ00066).
Receives: Other: Blood sample

What is being measured

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

  1. Stage I: Percentage of Participants With Seroresponse for Meningococcal Serogroups A, C, W & Y Measured by Serum Bactericidal Assay Using Human Complement (hSBA) After Vaccination With MenACYW Conjugate Vaccine in Study MEQ00066: Group 1 (Menomune-primed)

    Antibody titers against meningococcal serogroups A, C, W, and Y were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer greater than or equal to (>=) 1:16 for participants with pre-vaccination hSBA titer less than (<) 1:8, or a >= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer >= 1:8.

    Measured: Day 30 (post-vaccination) in study MEQ00066

Secondary outcomes (9)

  1. Stage I: Percentage of Participants With Vaccine Seroresponse for Meningococcal Serogroups A, C, W, and Y Measured by hSBA After Vaccination With MenACYW Conjugate Vaccine in Study MEQ00066: Group 2 (MenACYW Conjugate Vaccine-primed Participants)

    Antibody titers against meningococcal serogroups A, C, W, and Y were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer >= 1:16 for participants with pre-vaccination hSBA titer < 1:8, or a >= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer >= 1:8.

    Measured: Day 30 (post-vaccination) in study MEQ00066

  2. Stage I: Percentage of Participants With Vaccine Seroresponse for Meningococcal Serogroups A, C, W, and Y Measured by hSBA at Day 6 After Vaccination With MenACYW Conjugate Vaccine in Study MEQ00066: Groups 1 and 2

    Antibody titers against meningococcal serogroups A, C, W, and Y were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer >= 1:16 for participants with pre-vaccination hSBA titer < 1:8, or a >= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer >= 1:8.

    Measured: Day 6 (post-vaccination) in study MEQ00066

  3. Stage I: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA Before and After Vaccination With MenACYW Conjugate Vaccine in Study MEQ00066 (Groups 1 to 4)

    GMTs of antibodies against meningococcal serogroups A, C, W, and Y 135 were measured by hSBA. Titers are expressed in terms of 1/dilution. At Baseline, Group 1 was equivalent to Group 3 (both groups were Menomune-primed in MET49) and Group 2 was equivalent to Group 4 (both groups were MenACYW Conjugate Vaccine-primed in MET49), therefore it was planned to collect and present pooled data of Groups 1 and 3 and Groups 2 and 4 for Day 0 (pre-vaccination) in this outcome measure. Here, "0" in the number analyzed field for Day 30 signifies that data were not planned to be collected and analyzed for Groups 3 and 4 participants as pre-specified in the protocol.

    Measured: Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MEQ00066

  4. Stage I: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA: Groups 5 and 6

    GMTs of antibodies against meningococcal serogroups A, C, W, and Y were measured by hSBA. Titers were expressed in terms of 1/dilution.

    Measured: Day 0 (pre-vaccination in MEQ00066)

  5. Stage I: Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA After Primary Vaccination With Menomune Vaccine or MenACYW Conjugate Vaccine: Groups 1 to 6

    Antibody titers against meningococcal serogroups A, C, W, and Y were measured by hSBA.

    Measured: Day 0 (pre-vaccination) in study MEQ00066

  6. Stage II: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA After Primary Vaccination With Menomune Vaccine or MenACYW Conjugate Vaccine: Groups 3 and 4

    GMTs of antibodies against meningococcal serogroups A, C, W, and Y were measured by hSBA. Titers were expressed in terms of 1/dilution.

    Measured: 5 years post primary vaccination (with Menomune or MenACYW Conjugate vaccine) in study MET49

  7. Stage II: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, W, and Y Measured by rSBA After Primary Vaccination With Menomune Vaccine or MenACYW Conjugate Vaccine: Groups 3 and 4

    GMTs of antibodies against meningococcal serogroups A, C, W, and Y were measured by rSBA. Titers were expressed in terms of 1/dilution.

    Measured: 5 years post primary vaccination (with Menomune or MenACYW Conjugate vaccine) in study MET49

  8. Stage II: Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA After Primary Vaccination With Menomune Vaccine or MenACYW Conjugate Vaccine: Groups 3 and 4

    Antibody titers against meningococcal serogroups A, C, W, and Y were measured by hSBA.

    Measured: 5 years post primary vaccination (with Menomune or MenACYW Conjugate vaccine) in study MET49

  9. Stage II: Percentage of Participants With Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W Measured by rSBA After Primary Vaccination With Menomune Vaccine or MenACYW Conjugate Vaccine: Groups 3 and 4

    Antibody titers against meningococcal serogroups A, C, W, and Y were measured by rSBA.

    Measured: 5 years post primary vaccination (with Menomune or MenACYW Conjugate vaccine) in study MET49

Timeline

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

  1. First posted29 Oct 2019
  2. Study start4 Oct 2019
  3. Primary completion1 Apr 2020
  4. Study completion25 May 2022

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
471 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04142242
Sponsor's protocol ID
MEQ00066
Other IDs
U1111-1217-2058
Status last verified
Sep 2025
First submitted
24 Oct 2019
Last updated
11 Sep 2025
Data monitoring committee
No
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

Publications

  • Robertson CA, Jacqmein J, Selmani A, Galarza K, Oster P. Immune persistence and booster response of a quadrivalent meningococcal conjugate vaccine (MenACYW-TT) 5 years after primary vaccination of adults at >/=56 years of age. Hum Vaccin Immunother. 2024 Dec 31;20(1):2426868. doi: 10.1080/21645515.2024.2426868. Epub 2024 Nov 18.

    PubMed 39555800

  • Robertson CA, Jacqmein J, Selmani A, Galarza K, Oster P. Immunogenicity and safety of a quadrivalent meningococcal conjugate vaccine (MenACYW-TT) administered as a booster to adults aged >/=59 years: A phase III randomized study. Hum Vaccin Immunother. 2023 Dec 31;19(1):2160600. doi: 10.1080/21645515.2022.2160600. Epub 2023 Jan 11.

    PubMed 36632042

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Meningococcal Polysaccharide (serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine and Blood sample in people with Meningococcal Infection (Healthy Volunteers), run by Sanofi Pasteur, a Sanofi Company at 34 sites in 2 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 2 inclusion and 20 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 34 sites in United States, Puerto Rico. 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?

Yes. Results are posted in the registry (first posted 26 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

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

What does the primary outcome measure?

Stage I: Percentage of Participants With Seroresponse for Meningococcal Serogroups A, C, W & Y Measured by Serum Bactericidal Assay Using Human Complement (hSBA) After Vaccination With MenACYW Conjugate Vaccine in Study MEQ00066: Group 1 (Menomune-primed) (time frame: Day 30 (post-vaccination) in study MEQ00066). 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 NCT04142242, which also lists 2 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 11 Sep 2025.

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