Lyme DiseasePhase 3NCT07500506
A Study to Learn About the Safety, Tolerability, and Immunogenicity of a Fifth Dose of 6-Valent OspA-Based Lyme Disease Vaccine
A Phase 3 study testing VLA15 in people with Lyme Disease, run by Pfizer at 22 sites in 2 countries.
Trial summary
The purpose of this study is to learn about the safety effects of the Lyme disease vaccine (called VLA15), and its ability to protect people from Lyme disease after a 5th dose of the vaccine. Read more about this study
- Who is it for?
- Ages 7 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lyme Disease
- What is being tested?
- VLA15
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,712 participants
- Where
- 22 sitesin 2 countries
- Study dates
- 8 Apr 2026to 4 Dec 2026
- 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 7 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Participants who are healthy as determined by medical history and clinical judgment.
- Participants willing and able to comply with all scheduled visits, IP receipt, and other procedures throughout the study.
- Able to provide Informed Consent.
- Participants must have received 4 doses of VLA15 in the C4601003 study, and have a V7 blood sample available.
Who cannot join
- Pregnant or breastfeeding participants.
- Allergies or contraindications to vaccines or their components.
- Health issues including: blood clotting deficiencies, immunodeficiencies, bone marrow disorder, or uncontrolled psychiatric conditions.
- Receipt of therapies to treat malignancies, blood/plasma products and immunoglobulins, systemic corticosteroids and immunosuppressants, or anticoagulant therapy in recent medical history.
- Recent or concurrent participation in a separate interventional study.
- Staff or direct family of the study site staff and Sponsor.
Trial locations and contacts
22 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
22 sites in 2 countries
United States19 sites, 19 recruiting
- Not yet recruiting
Northern Light Eastern Maine Medical Center
Bangor, Maine, 04401
- Not yet recruiting
Northern Light Family Medicine and Residency Center
Bangor, Maine, 04401
- Not yet recruiting
The University of Vermont Medical Center Inc.
Burlington, Vermont, 05401
- Recruiting
Smith Allergy and Asthma Specialists
Cortland, New York, 13045
- Recruiting
Altoona Center For Clinical Research
Duncansville, Pennsylvania, 16635
- Not yet recruiting
Velocity Clinical Research, Providence
East Greenwich, Rhode Island, 02818
- Recruiting
Allegheny Health and Wellness Pavilion
Erie, Pennsylvania, 16506
- Recruiting
Central Erie Primary Care
Erie, Pennsylvania, 16508
- Not yet recruiting
Hunterdon Medical Center
Flemington, New Jersey, 08822
- Recruiting
Smith Allergy & Asthma Specialists
Horseheads, New York, 14845
- Recruiting
Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)
Pittsburgh, Pennsylvania, 15236
- Not yet recruiting
Preferred Primary Care Physicians, Preferred Clinical Research - St.Clair
Pittsburgh, Pennsylvania, 15243
- Recruiting
Robert Packer Hospital
Sayre, Pennsylvania, 18840
- Recruiting
Frontier Clinical Research, LLC
Scottdale, Pennsylvania, 15683
- Recruiting
Northeast Clinical Trials Group
Scranton, Pennsylvania, 18510
- Recruiting
Frontier Clinical Research, LLC
Smithfield, Pennsylvania, 15478
- Not yet recruiting
Preferred Primary Care Physicians
Uniontown, Pennsylvania, 15401
- Not yet recruiting
Amherst Family Practice, P.C.
Winchester, Virginia, 22601
- Recruiting
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01655
Canada3 sites, 3 recruiting
- Not yet recruiting
Milestone Research Inc.
London, Ontario, N5W 6A2
- Recruiting
Diex Recherche Inc. Division Sherbrooke
Sherbrooke, Quebec, J1L 0H8
- Not yet recruiting
Stouffville Medical Research Institute Inc.
Stouffville, Ontario, L4A 1H2
About this study
Official title: A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLINDED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A FIFTH DOSE OF 6-VALENT OSPA-BASED LYME DISEASE VACCINE, VLA15, IN HEALTHY PARTICIPANTS ≥7 YEARS OF AGE
The purpose of this study is to learn about the safety effects of the Lyme disease vaccine (called VLA15), and its ability to protect people from Lyme disease after a 5th dose of the vaccine.
This study is seeking participants who:
Read more
- are generally healthy and 7 years of age and older,
- have already been vaccinated with 4 doses of VLA15 (from the VALOR study), and have blood sample taken post dose 4.
- are not currently taking, or haven't recently taken, medicines like chemotherapy, blood products, or blood thinners.
- are not pregnant or breastfeeding and do not plan to become pregnant while receiving the study vaccine.
All participants in this study will receive a total of 1 dose through a shot in the upper arm, either VLA15 or saline shot (saltwater).
The study will compare the experiences of people receiving the study vaccine or saltwater shot.
Participants will take part in this study for about 12 months. During this time, they will have 4 planned clinic visits. The clinic visits may include having a health check, giving a small amount of blood and getting the study vaccine or saltwater as a shot at the first visit.
Read the detailed description
A Phase 3, Randomized, Placebo-Controlled, Double-Blinded Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Fifth Dose of 6-Valent OspA-Based Lyme Disease Vaccine, VLA15, in Healthy Participants ≥7 Years of Age
Participants will be randomized in a 5:1 ratio to receive either one dose of VLA15 or placebo (saline) at the first visit. This study will use an external data monitoring committee (EDMC). The EDMC is independent of the Pfizer study team and includes only external members. The EDMC charter describes the role of the EDMC in more detail.
Approximately 1712 participants will be enrolled in the study.
Healthy individuals 7 years of age and older who have received 4 prior doses of active VLA15 from the C4601003 study, have a blood sample taken post dose 4, are willing to comply with all study procedures, and provide signed informed consent will be enrolled. Pregnant or breastfeeding individuals and fertile individuals who are unwilling or unable to use effective contraceptive methods as outlined in this protocol will not be enrolled. Individuals who have contraindication to vaccination, conditions or treatments that can inhibit the ability to mount an immune response to a vaccine, or other conditions that may increase the risk of study participation will be excluded from this study.
- Conditions
- Lyme Disease
- Being tested
- VLA15, Placebo
- Medical subject headings
- Lyme Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VLA15Biological
VLA15 injection IM
PlaceboBiological
Saline Injection
| Study group | Role | What they receive |
|---|---|---|
| VLA15-1A | Experimental | Participants will receive a single injection in the muscle (IM) of VLA15 at Visits 1, two years after their 4th dose of VLA15 Receives: Biological: VLA15 |
| VLA15-1B | Placebo comparator | Participants will receive a single injection in the muscle (IM) of Saline at Visits 1, two years after their 4th dose of VLA15 Receives: Biological: Placebo |
| VLA15-2A | Experimental | Participants will receive a single injection in the muscle (IM) of VLA15 at Visits 1, one year after their 4th dose of VLA15 Receives: Biological: VLA15 |
| VLA15-2B | Placebo comparator | Participants will receive a single injection in the muscle (IM) of saline at Visits 1, one year after their 4th dose of VLA15 Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants reporting prespecified local reactions
Measured: Within 7 days following each study intervention administration
Percentage of participants reporting prespecified systemic events
Measured: Within 7 days following each study intervention administration
Percentage of participants reporting adverse events (AEs)
Measured: Through 1 month following study intervention administration
Percentage of participants reporting newly diagnosed chronic medical conditions (NDCMCs)
Measured: Through study completion, up to approximately 12 months.
Percentage of participants reporting serious adverse events (SAEs)
Measured: Through study completion, up to approximately 12 months.
Geometric mean ratio (GMR) of anti-OspA IgG concentrations for each serotype (ST1-ST6)
Objective to determine non-inferiority of Dose 5 compared to Dose 4 in all participants when there is a 1 year gap between Dose 4 and Dose 5.
Measured: At 1 month after completion of Dose 5
Sero-response of anti-OspA IgG concentrations for each serotype (ST1-ST6).
Difference in seroresponse rate between 1 month after Dose 5 and 1 month after Dose 4 for each serotype in all participants ≥7 years of age who received a fifth dose of VLA15 1 year after their fourth dose of VLA15.
Measured: At 1 month after completion of Dose 5
Secondary outcomes (9)
Geometric mean ratio (GMR) of anti-OspA IgG concentrations for each serotype (ST1-ST6)
Objective to determine non-inferiority of Dose 5 compared to Dose 4 in adult participants when there is a 1 year gap between Dose 4 and Dose 5.
Measured: At 1 month after completion of Dose 5
Geometric mean ratio (GMR) of anti-OspA IgG concentrations for each serotype (ST1-ST6)
Objective to determine non-inferiority of Dose 5 compared to Dose 4 in all participants when there is a 2 year gap between Dose 4 and Dose 5.
Measured: At 1 month after completion of Dose 5
Geometric mean ratio (GMR) of anti-OspA IgG concentrations for each serotype (ST1-ST6)
Objective to describe the immune response following Dose 5 compared to Dose 4 in pediatric participants when there is a 1 year gap between Dose 4 and Dose 5.
Measured: At 1 month after completion of Dose 5
Geometric mean ratio (GMR) of anti-OspA IgG concentrations for each serotype (ST1-ST6)
Objective to describe the immune response following Dose 5 compared to Dose 4 in all participants (by age group) when there is a 2 year gap between Dose 4 and Dose 5.
Measured: At 1 month after completion of Dose 5
Geometric mean fold rise (GMFR) of anti-OspA IgG concentrations for each serotype (ST1-ST6)
Objective to describe the immune response following Dose 5 compared to Dose 4 in all participants when there is a 1 or 2 year gap between Dose 4 and Dose 5.
Measured: At just prior to Dose 5 and 1 month after completion of Dose 5
Geometric mean concentration (GMC) of anti-OspA IgG concentrations for each serotype (ST1-ST6)
Objective to describe the immune response following Dose 5 compared to Dose 4 in all participants when there is a 1 or 2 year gap between Dose 4 and Dose 5.
Measured: At 1 month after completion of Dose 5
Sero-response of anti-OspA IgG concentrations for each serotype (ST1-ST6).
Difference in seroresponse rate between 1 month after Dose 5 and 1 month after Dose 4 for each serotype in adult participants ≥18 years of age who received a fifth dose of VLA15 1 year after their fourth dose of VLA15.
Measured: At 1 month after completion of Dose 5
Sero-response of anti-OspA IgG concentrations for each serotype (ST1-ST6).
Difference in seroresponse rate between 1 month after Dose 5 and 1 month after Dose 4 for each serotype in all participants ≥7 years of age who received a fifth dose of VLA15 2 years after their fourth dose of VLA15.
Measured: At 1 month after completion of Dose 5
Sero-response of anti-OspA IgG concentrations for each serotype (ST1-ST6).
Seroresponse rate at 1 month after Dose 5 using pre-Dose 1 and pre-Dose 5 seroresponse rates as baseline in all participants who received a fifth dose of VLA15 1 year and 2 years after their fourth dose of VLA15.
Measured: At 1 month after completion of Dose 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start8 Apr 2026
- Primary completion4 Dec 2026 (estimated)
- Study completion4 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lyme DiseaseStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,712 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07500506
- Sponsor's protocol ID
- C4601016
- Status last verified
- May 2026
- First submitted
- 23 Mar 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLINDED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A FIFTH DOSE OF 6-VALENT OSPA-BASED LYME DISEASE VACCINE, VLA15, IN HEALTHY PARTICIPANTS ≥7 YEARS OF AGE
- ClinicalTrials.gov ID
- NCT07500506
- Acronym / sponsor ID
- C4601016
- Conditions
- Lyme Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,712 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2026 (actual)
- Primary completion
- 4 Dec 2026 (estimated)
- Study completion
- 4 Dec 2026 (estimated)
- First posted
- 30 Mar 2026 (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 this study is to learn about the safety effects of the Lyme disease vaccine (called VLA15), and its ability to protect people from Lyme disease after a 5th dose of the vaccine.
This study is seeking participants who:
- are generally healthy and 7 years of age and older,
- have already been vaccinated with 4 doses of VLA15 (from the VALOR study), and have blood sample taken post dose 4.
- are not currently taking, or haven't recently taken, medicines like chemotherapy, blood products, or blood thinners.
- are not pregnant or breastfeeding and do not plan to become pregnant while receiving the study vaccine.
All participants in this study will receive a total of 1 dose through a shot in the upper arm, either VLA15 or saline shot (saltwater).
The study will compare the experiences of people receiving the study vaccine or saltwater shot.
Participants will take part in this study for about 12 months. During this time, they will have 4 planned clinic visits. The clinic visits may include having a health check, giving a small amount of blood and getting the study vaccine or saltwater as a shot at the first visit.
Detailed description
A Phase 3, Randomized, Placebo-Controlled, Double-Blinded Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Fifth Dose of 6-Valent OspA-Based Lyme Disease Vaccine, VLA15, in Healthy Participants ≥7 Years of Age
Participants will be randomized in a 5:1 ratio to receive either one dose of VLA15 or placebo (saline) at the first visit. This study will use an external data monitoring committee (EDMC). The EDMC is independent of the Pfizer study team and includes only external members. The EDMC charter describes the role of the EDMC in more detail.
Approximately 1712 participants will be enrolled in the study.
Healthy individuals 7 years of age and older who have received 4 prior doses of active VLA15 from the C4601003 study, have a blood sample taken post dose 4, are willing to comply with all study procedures, and provide signed informed consent will be enrolled. Pregnant or breastfeeding individuals and fertile individuals who are unwilling or unable to use effective contraceptive methods as outlined in this protocol will not be enrolled. Individuals who have contraindication to vaccination, conditions or treatments that can inhibit the ability to mount an immune response to a vaccine, or other conditions that may increase the risk of study participation will be excluded from this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| VLA15-1A | Experimental | Biological: VLA15Participants will receive a single injection in the muscle (IM) of VLA15 at Visits 1, two years after their 4th dose of VLA15 |
| VLA15-1B | Placebo comparator | Biological: PlaceboParticipants will receive a single injection in the muscle (IM) of Saline at Visits 1, two years after their 4th dose of VLA15 |
| VLA15-2A | Experimental | Biological: VLA15Participants will receive a single injection in the muscle (IM) of VLA15 at Visits 1, one year after their 4th dose of VLA15 |
| VLA15-2B | Placebo comparator | Biological: PlaceboParticipants will receive a single injection in the muscle (IM) of saline at Visits 1, one year after their 4th dose of VLA15 |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Participants who are healthy as determined by medical history and clinical judgment.
- Participants willing and able to comply with all scheduled visits, IP receipt, and other procedures throughout the study.
- Able to provide Informed Consent.
- Participants must have received 4 doses of VLA15 in the C4601003 study, and have a V7 blood sample available.
Key exclusion criteria (6 listed)
- Pregnant or breastfeeding participants.
- Allergies or contraindications to vaccines or their components.
- Health issues including: blood clotting deficiencies, immunodeficiencies, bone marrow disorder, or uncontrolled psychiatric conditions.
- Receipt of therapies to treat malignancies, blood/plasma products and immunoglobulins, systemic corticosteroids and immunosuppressants, or anticoagulant therapy in recent medical history.
- Recent or concurrent participation in a separate interventional study.
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 |
|---|---|---|
| VLA15VLA15 injection IM | Biological | VLA15-1A, VLA15-2A |
| PlaceboSaline Injection | Biological | VLA15-1B, VLA15-2B |
Primary outcome
Percentage of participants reporting prespecified local reactions
Time frame: Within 7 days following each study intervention administration
Percentage of participants reporting prespecified systemic events
Time frame: Within 7 days following each study intervention administration
Percentage of participants reporting adverse events (AEs)
Time frame: Through 1 month following study intervention administration
Percentage of participants reporting newly diagnosed chronic medical conditions (NDCMCs)
Time frame: Through study completion, up to approximately 12 months.
Percentage of participants reporting serious adverse events (SAEs)
Time frame: Through study completion, up to approximately 12 months.
Geometric mean ratio (GMR) of anti-OspA IgG concentrations for each serotype (ST1-ST6)
Time frame: At 1 month after completion of Dose 5
Objective to determine non-inferiority of Dose 5 compared to Dose 4 in all participants when there is a 1 year gap between Dose 4 and Dose 5.
Sero-response of anti-OspA IgG concentrations for each serotype (ST1-ST6).
Time frame: At 1 month after completion of Dose 5
Difference in seroresponse rate between 1 month after Dose 5 and 1 month after Dose 4 for each serotype in all participants ≥7 years of age who received a fifth dose of VLA15 1 year after their fourth dose of VLA15.
9 secondary outcomes
Geometric mean ratio (GMR) of anti-OspA IgG concentrations for each serotype (ST1-ST6)
Time frame: At 1 month after completion of Dose 5
Geometric mean ratio (GMR) of anti-OspA IgG concentrations for each serotype (ST1-ST6)
Time frame: At 1 month after completion of Dose 5
Geometric mean ratio (GMR) of anti-OspA IgG concentrations for each serotype (ST1-ST6)
Time frame: At 1 month after completion of Dose 5
Geometric mean ratio (GMR) of anti-OspA IgG concentrations for each serotype (ST1-ST6)
Time frame: At 1 month after completion of Dose 5
Geometric mean fold rise (GMFR) of anti-OspA IgG concentrations for each serotype (ST1-ST6)
Time frame: At just prior to Dose 5 and 1 month after completion of Dose 5
Geometric mean concentration (GMC) of anti-OspA IgG concentrations for each serotype (ST1-ST6)
Time frame: At 1 month after completion of Dose 5
Sero-response of anti-OspA IgG concentrations for each serotype (ST1-ST6).
Time frame: At 1 month after completion of Dose 5
Sero-response of anti-OspA IgG concentrations for each serotype (ST1-ST6).
Time frame: At 1 month after completion of Dose 5
Sero-response of anti-OspA IgG concentrations for each serotype (ST1-ST6).
Time frame: At 1 month after completion of Dose 5
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 6 May 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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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.
Pfizer CT.gov Call Center study director
Pfizer
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VLA15 in people with Lyme Disease, run by Pfizer at 22 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 4 inclusion and 6 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 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Canada. 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. Some participants in this study may receive a placebo. 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 Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants reporting prespecified local reactions (time frame: Within 7 days following each study intervention administration). The study lists 7 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 6 May 2026.