Study Comparing Different Injection Methods of Yellow Fever Vaccine in Adults
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This clinical trial is focused on studying yellow fever, a viral infection transmitted by mosquitoes, which can cause symptoms ranging from fever and chills to more severe complications. The study will use a vaccine called STAMARIL®, which contains a live, weakened form of the yellow fever virus strain 17D-204. The purpose of the study is to compare how well the vaccine works when given through different methods: under the skin (intradermal), into the muscle (intramuscular), and under the skin (subcutaneous).
Participants in the study will receive the STAMARIL® vaccine in one of these three ways. The study will observe the body's immune response, specifically looking at the presence of certain immune cells in the skin and blood after vaccination. The study will also monitor any side effects that occur after receiving the vaccine. The goal is to understand which method of vaccination is most effective in producing a strong immune response against yellow fever.
The study will take place over a period of time, with participants being monitored for their immune response and any side effects up to 120 days after vaccination. This research aims to provide valuable information on the best way to administer the yellow fever vaccine to ensure maximum protection against the disease.
The research process
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
6 criteria
- Must be between 18 and 50 years old.
- Body Mass Index (BMI) must be between 18.5 and 30 kg/m2. BMI is a measure of body fat based on height and weight.
- Must agree not to donate blood or receive other vaccinations for 30 days after the study vaccination.
- Must agree to share and discuss their medical history and records when necessary.
- Must be able and willing to provide written informed consent. This means you understand the study and agree to participate.
- If you are a woman who can have children, you must agree to use a highly effective method of contraception for up to 30 days after the study vaccination.
Who cannot join the trial?
9 criteria
- People who have had a severe allergic reaction to a previous yellow fever vaccine.
- Individuals with a weakened immune system, which means their body has a harder time fighting infections.
- Pregnant women or those who are breastfeeding.
- Children under 9 months of age.
- People with a history of problems with their thymus, a small organ in the chest that helps the immune system.
- Anyone currently experiencing a fever or an active infection.
- Individuals who have received another live vaccine within the last 4 weeks.
- People who are allergic to eggs, as the vaccine may contain egg proteins.
- Anyone who has a history of severe allergies to any component of the vaccine.
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Investigated drugs
Yellow Fever Vaccine is a vaccine used to protect against yellow fever, a viral infection spread by mosquitoes. In this clinical trial, the vaccine is being studied to see how well it works when given in different ways: into the skin (intradermal), under the skin (subcutaneous), or into the muscle (intramuscular). The goal is to understand which method of giving the vaccine helps the body create the best immune response, specifically looking at certain immune cells in the skin that remember the virus and help protect against future infections.
What is already known about the treatment
Investigated diseases
sourced from the EU Clinical Trials Register and site verification
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