Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi Pasteur, a Sanofi Company
Age
4–6
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Healthy, as determined by medical history and physical examination.
Aged 4 to 6 (\< 7) years at the time of study vaccination on Day 0.
Signed and dated informed consent form that has been approved by the Institutional Review Board (IRB) by the parent or legally authorized representative.
Signed and dated informed assent form from the subject if required by the IRB.
Able to attend scheduled visits at Visit 1 and Visit 2 and able to comply with all trial procedures. Subjects will be invited to participate in the long-term immunogenicity follow-up study but a commitment to participate in the long-term is not required as an inclusion criterion.
Documented vaccination history of 4 previous doses of DAPTACEL according to the recommended national immunization schedule for Diphtheria, tetanus and acellular pertussis (DTaP).
You may not be if
Participation in another clinical trial in the 4 weeks preceding the trial vaccination.
Planned participation in another clinical trial during the original trial period.
Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.
Systemic hypersensitivity to any of the vaccine components or history of life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
Chronic illness at a stage that could interfere with trial conduct or completion.
Blood or blood-derived products received in the past 3 months.
Receipt of any other vaccine within 30 days prior to study vaccination, or planning to receive another vaccine within 30 days before the Visit 2 blood draw (with the exception of the annual influenza vaccine).
History of diphtheria, tetanus or pertussis infection (confirmed either serologically or microbiologically).
Thrombocytopenia or bleeding disorder contraindicating intra muscular vaccination.
Clareo Health | Safety and Immunogenicity of Tdap Vaccine Compared to DTaP Vaccine in Children 4 to 6 Years of Age
