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Tests treatment safety and results for Yellow Fever Immunization
Official title A Phase III Control Study of the Safety and Immunogenicity of vYF in Pediatric Population
ClinicalTrials.gov ID: NCT07103148
What this study is testing
What is Yellow fever vaccine (live)?
Yellow fever vaccine (live) is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for yellow fever immunization.
Also referred to as vYF vaccine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to determine whether vYF (investigational vaccine) is safe and can help the body to develop antibodies (immunogenicity) compared with Stamaril vaccine and YF-VAX vaccine (both licensed vaccines) and when they are co-administered with Measles Mumps Rubella (MMR) vaccines in infants aged 11-15 months. Number of Participants: A total of 2440 participants is planned to be enrolled in VYF04 study.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 9 to 5. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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...
- 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...
- Participant and parent/LAR are able to attend all scheduled visits and to comply with all study procedures
You likely can't join if
- 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...
- 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...
- Moderate or severe acute illness/infection (according to Investigator judgment) or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) on the day of...
- Chronic illness\ that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion , including...
See the full eligibility 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...
- 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)
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- San Pedro Sula, Honduras
- San Pedro Sula, Cortes, Honduras
- Tegucigalpa, Honduras
- Torreón, Coahuila, Mexico
- Cuernavaca, Morelos, Mexico
- Tizimín, Yucatán, Mexico
- Chihuahua City, Mexico
- Ecatepec de Morelos, Mexico
- Panama City, Panama
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 9 months to 5 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Pedro Sula, Honduras; San Pedro Sula, Cortes, Honduras; Tegucigalpa, Honduras; Torreón, Coahuila, Mexico; Cuernavaca, Morelos, Mexico; Tizimín, Yucatán, Mexico and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.