New yellow fever vaccine trial for kids could boost global protection
NCT ID NCT07103148
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This Phase 3 trial tests a new yellow fever vaccine (vYF) in about 2,440 healthy children aged 9 months to 5 years. Researchers will compare vYF to two licensed vaccines (Stamaril and YF-VAX) to see if it triggers a strong immune response and is safe. Some children will also receive the MMR vaccine at the same time. The study lasts about 3 years, with a booster dose option for some participants.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- yellow fever vaccine (vYF)
- What this could lead to
- If successful, this could provide a safe and effective yellow fever vaccine option for young children, potentially improving protection in endemic areas.
- What could go wrong
- This is a large Phase 3 trial, but results may not show vYF is as good as existing vaccines. Also, long-term safety and effectiveness beyond 3 years are not yet known.
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 2,440 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Mar 2030
An estimate. End dates often move.
- Lead sponsor
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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
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9 months to 5 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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: * Aged 9 months to 5 years on the day of inclusion\* \* "9 months to 5 years" means from the day of the 9th month after birth to the day before the 6th year birthday * Aged 11 to 15 months\* on the day of inclusion for participants enrolled in the MMR co-administration group \* "11 to 15 months" means from the day of the 11th month after birth to the day before the 16th month birthday * Participants who are healthy as determined by medical evaluation including medical history and physical examination * For infants\*, born after a gestation period of 27 through 36 weeks and 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 \* Infants aged 9 months to 11 months up to the day before the 12th month birthday * Participant and parent/LAR are able to attend all scheduled visits and to comply with all study procedures * ICF has been signed and dated by the parent(s) or other LAR (and by an independent witness if required by local regulations) Exclusion Criteria: 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 irradiation 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) * Known history of FV infection * Known systemic hypersensitivity to any of the study intervention components, eggs 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 * Moderate or severe acute illness/infection (according to Investigator judgment) or febrile illness (temperature ≥ 38.0°C \[≥ 100.4°F\]) on the day of study intervention administration. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided. * Chronic illness\* that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion , including malignancy, such as leukemia, or lymphoma \*Chronic illness may include, but is not limited to, cardiac disorders, renal disorders, auto-immune disorders, diabetes, psychiatric disorders or chronic infection * History of central nervous system disorder or disease, including seizures and febrile seizures * Receipt of any vaccine in the 4 weeks preceding the study intervention administration or planned receipt of any vaccine in the 4 weeks following the study intervention administration. Vaccine to be administered as part of the National Immunization Schedule will be postponed after the D29 visit * Previous vaccination against a FV disease at any time including YF with an investigational or marketed vaccine * Receipt of immune globulins, blood or blood-derived products in the past 6 months * Administration of any anti-viral within 2 months preceding the study intervention administration and up to the 6 weeks following the study intervention administration * For participants enrolled in the MMR co-administration group: previous vaccination against measles, measles/mumps/rubella * For participants enrolled in the MMR co-administration group: history of measles, mumps, rubella confirmed either clinically, serologically, or microbiologically * Known history or laboratory evidence of HIV infection * Known history of hepatitis B or hepatitis C seropositivity * Personal or family history of thymic pathology (thymoma, thymectomy, or myasthenia) * Participation at the time of study enrollment (or in the 4 weeks preceding the study intervention administration) or planned participation during the first year of the 3-year follow-up in another clinical study investigating a vaccine, drug, medical device, or medical procedure. Enrollment in another study after the first 6 months of follow-up is permitted, assuming it does not exclude participation in this study. * In an emergency setting, or hospitalized involuntary * Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
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Genom att skicka in godkänner du våra Användarvillkor
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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
13 sites in 3 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Investigational Site Number : 3400001
RECRUITINGSan Pedro Sula, 21104, Honduras
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Investigational Site Number : 3400002
RECRUITINGTegucigalpa, 11101, Honduras
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Investigational Site Number : 3400003
RECRUITINGTegucigalpa, 11101, Honduras
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Investigational Site Number : 3400005
RECRUITINGSan Pedro Sula, Cortes, 21104, Honduras
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Investigational Site Number : 3400007
RECRUITINGTegucigalpa, 11101, Honduras
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Investigational Site Number : 4840005
RECRUITINGEcatepec de Morelos, 55075, Mexico
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Investigational Site Number : 4840007
RECRUITINGTorreón, Coahuila, 27000, Mexico
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Investigational Site Number : 4840009
RECRUITINGChihuahua City, 31000, Mexico
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Investigational Site Number : 4840013
RECRUITINGCuernavaca, Morelos, 62290, Mexico
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Investigational Site Number : 4840015
RECRUITINGTizimín, Yucatán, 97700, Mexico
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Investigational Site Number : 5910001
RECRUITINGPanama City, 10662, Panama
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Investigational Site Number : 5910002
RECRUITINGPanama City, 10662, Panama
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Investigational Site Number : 5910003
RECRUITINGPanama City, 10662, Panama
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