Stichting Radboud University Medical Center
Nijmegen, The Netherlands
Rare diseases
Investigational molecules
Locations
A plain-language summary of the goals, design and what participants do
This clinical trial focuses on studying pertussis, also known as whooping cough, a contagious respiratory disease. The study aims to investigate how booster vaccination affects bacterial colonization in the nose after controlled exposure to Bordetella pertussis bacteria. The research compares two different vaccines: Repevax (a combination vaccine that protects against diphtheria, tetanus, pertussis, and polio) and Revaxis (a vaccine that protects against diphtheria, tetanus, and polio).
During the study, participants will receive one of these vaccines as a booster shot. Later, they will be exposed to a carefully controlled amount of pertussis bacteria through the nose. The researchers will then collect samples from the nose over several weeks to check for the presence of bacteria. Participants will receive azithromycin, an antibiotic, as part of the study protocol to ensure safety.
This is a Phase 4 study, which means the vaccines being tested are already approved for use but are being studied to gather additional information about their effects. The study will help understand how vaccination might prevent the bacteria from establishing itself in the nose, which could reduce the spread of whooping cough in communities.
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
7 criteria
14 criteria
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Nijmegen, The Netherlands
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(Tetanus, diphtheria, acellular pertussis, and inactivated polio vaccine) is a combination vaccine that helps protect against four different diseases. It contains inactivated bacteria and viruses that stimulate the immune system to create antibodies against tetanus, diphtheria, whooping cough (pertussis), and polio.
(Tetanus, diphtheria, and inactivated polio vaccine) is a combination vaccine that protects against three diseases. Unlike Tdap-IPV, this vaccine does not include the pertussis component. It contains inactivated bacteria and viruses that help the body create antibodies against tetanus, diphtheria, and polio.
is not a medication but a bacterial strain used in this study for controlled human infection to study colonization. It is the bacteria that causes whooping cough and is administered intranasally (through the nose) as part of the research protocol.
A combination vaccine administered through intramuscular injection that provides protection against tetanus, diphtheria, acellular pertussis, and polio. This vaccine is widely used in medical practice as a booster shot for adolescents and adults, particularly effective in preventing whooping cough (pertussis) transmission. The vaccine works by stimulating the immune system to produce antibodies against these specific pathogens, with the acellular pertussis component targeting specific proteins of the Bordetella pertussis bacteria.
A combination vaccine given via intramuscular injection that protects against tetanus, diphtheria, and polio, but does not include the pertussis component. This vaccine serves as a standard booster immunization for adults and is commonly used when pertussis protection is not required. The vaccine stimulates the production of protective antibodies against tetanus, diphtheria toxoids, and poliovirus, providing long-term immunity against these diseases.
sourced from the EU Clinical Trials Register and site verification
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