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Chikungunya vaccine trial for kids pulled before start

NCT ID NCT07133178

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study was designed to test a vaccine called VLA1553 to protect healthy children aged 1 to 11 years from chikungunya, a virus spread by mosquitoes. The plan was to give the vaccine or a comparison shot to over 3,000 children and check for immune responses and safety. However, the trial was withdrawn before any participants were enrolled.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 year to 11 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female healthy children aged 7 to 11 years for Stratum A, 3 to 6 years for Stratum B and 1 to 2 years for Stratum C at the time of obtaining participant informed consent / assent; 2. Written informed consent by the participant's parent(s) / Legally Acceptable Representative(s) (LAR(s), according to local requirements, and written informed assent of the participant, if applicable; 3. Participant is generally healthy as determined by the Investigator's clinical judgement based on medical history, physical examination and screening laboratory tests; 4. Participants in Stratum C (1 to 2 years) must be within the normal WHO growth and weight ranges for their age. 5. Participant is seropositive for previous CHIKV exposure (i.e. IgM+ / IgG+ or IgM- / IgG+) or seronegative (i.e. IgM- / IgG-); 6. If participant is of childbearing potential (e.g. after onset of menarche) and if involved in activities that could result in pregnancy: 1. Female participant has a negative pregnancy test (in accordance with local regulations) at Screening (Visit 0) and Day 1 (Visit 1), respectively; 2. Female participant has practiced an adequate method of contraception during at least the 30 days before Screening (Visit 0) and during the Screening period; 3. Female/ male participant agrees to employ adequate birth control measures ) for the first three months post-vaccination (i.e. until Day 85, Visit 5). Exclusion Criteria: 1. Participant who is anti-CHIKV IgM+ / IgG- does not qualify for participation in this trial. 2. Participant is taking medication or other treatment for unresolved symptoms attributed to a previous CHIKV infection; or has participated in a clinical trial involving an investigational CHIKV vaccine; 3. Participant has an acute or recent infection and who is not symptom-free in the week prior to both the Screening visit (Visit 0) and Visit 1; 4. Participant has received another live virus vaccine within 28 days or inactivated / other vaccine within 14 days prior to vaccination in this trial or plans to receive a live virus vaccine within 28 days or inactivated vaccine / other within 14 days after vaccination; Whenever possible, standard of care vaccinations should be planned with the trial VLA1553 administration in mind. 5. Participant has an ongoing medical history of or currently has acute or progressive, unstable, controlled or uncontrolled clinical condition (e.g., cardiovascular, respiratory, neurologic, psychiatric, or rheumatologic conditions) that poses a risk for participation in the trial, based on the Investigators clinical judgement. Examples include individuals with controlled, poorly controlled or unstable disease, ongoing suspected or active inflammation, or poor compliance with pharmacologic treatment, or presence of high-risk comorbidities (e.g., significant cardiopulmonary disease); 6. Participant has abnormal findings in any required trial investigations (including medical history, physical examination, and clinical laboratory) considered clinically relevant by the Investigator which pose a risk for participation in the trial based on his / her judgement; 7. Participant has a history of immune-mediated or clinically relevant arthritis / arthralgia; 8. The participant, their parent(s) / LAR(s) or siblings have a known HIV, hepatitis B or hepatitis C infection; 9. Participant has a history of malignancy; 10. Participant has a known or suspected defect of the immune system that can be expected to influence the immune response to the vaccine, such as participants with congenital or acquired immunodeficiency, including infection with HIV, status post organ transplantation or immuno-suppressive therapy within 4 weeks prior to Visit 1. Immuno-suppressive therapy is defined as administration of chronic (longer than 14 days) prednisone or equivalent ≥0.05 mg / kg / day within 4 weeks prior to trial entry, radiation therapy or immunosuppressive cytotoxic drugs / monoclonal antibodies in the previous 3 years; topical and inhaled steroids are allowed. 11. Participant has a history of any vaccine related contraindicating event (e.g., anaphylaxis, allergy to components of VLA1553 or Nimenrix®, or other known contraindications including febrile convulsions); 12. Participant presents with clinical conditions representing severe bleeding disorders and medications interfering with blood clotting; 13. Participant is pregnant (positive pregnancy test - in accordance with local regulations - at Screening or Visit 1, respectively) or is lactating at the time of enrollment or, for participants involved in activities potentially leading to pregnancy: 1. female participants on unreliable contraception after onset of menarche 2. male participant does not agree to employ adequate birth control measures during the first three months: 14. Participant received blood-derived products (e.g. plasma) within 180 days prior to vaccination in this trial; 15. Participant has a rash, dermatological condition or tattoos that would, in the opinion of the Investigator, interfere with injection site AE measurement and rating; 16. Participant has participated in another clinical trial involving an investigational medicinal product (IMP) or device within 30 days prior to vaccination or is scheduled to participate in another clinical trial involving an IMP, or device at any time during this trial; 17. Participant has any condition that, in the opinion of the Investigator, may compromise the participants well-being, might interfere with evaluation of trial endpoints, or would limit the participant's ability to complete the trial; 18. Participant / Participant's parent(s) / LAR(s) is / are a member of the team conducting the trial or in a dependent relationship with one of the trial team members. Dependent relationships include close relatives (i.e., children, partner / spouse, siblings, parent(s) / LAR(s) as well as employees of the Investigator or site personnel conducting the trial; 19. Participant has received the comparator (Nimenrix® or any equivalent meningococcal conjugate vaccine covering serogroups A, C, W-135, and Y) prior to the trial.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

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Other studies related to the condition(s) this trial covers.