Safety and Immunogenicity Study of Tdap Vaccinations for Plasma Donors
Tetanus, Diphtheria and Acellular Pertussis Vaccination
About this trial
This is an interventional basic science trial for Tetanus, Diphtheria and Acellular Pertussis Vaccination focused on measuring Plasma, Plasma Donor, Plasma Donation, Hyperimmunization, Tetanus, Immunoglobulin
Eligibility Criteria
Inclusion Criteria: Male or female ages 18 to 63 years Females of childbearing potential who agree to employ highly effective birth control measures during the study Signed the informed consent form (ICF) Met all of the criteria required to be a Normal Source Plasma donor Subject is not participating in any other immunization program Subject has not had a Tdap vaccination in the last 90 days before the first study vaccination Exclusion Criteria: Subject is pregnant Subject has a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data Subject has repeated reactions or hypersensitivity to components in the vaccine Subject has history of a severe reaction to any immunization Subject has a history of Guillain-Barré Syndrome The Investigator concludes that the anticipated vaccination site (deltoid area) is not suitable for AE assessment
Sites / Locations
- ABO Plasma
Arms of the Study
Arm 1
Experimental
Tdap for Plasma Donors
Dose: 0.5 mL; Route: Intramuscular (IM) in the deltoid muscle; Frequency: Every 90 days; Duration: 5 doses over 1 year.