Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Biomat USA, Inc.
With
Hammond Clinical Trial Consulting, LLC
Axio Research. LLC
Age
18–69
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
1. Male or female ≥18\* years of age at Visit 1.
2. Subject has met all suitability criteria that would allow donation as a Normal Source Plasma donor
3. Subject has not been immunized for tetanus within the prior three (3) months
4. Subject is not participating in any other immunization program
5. Subject possesses a pre-existing antibody for tetanus of at least 0.15 IU/mL
You may not be if
1. Pregnant.
2. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
3. Subject has a hypersensitivity to components in the vaccine (e.g., thimerosal, latex, etc.)
4. Subject has history of a severe reaction to any immunization
5. Subject has a history of Guillain-Barré Syndrome
6. Subject is unable to read and/or write due to illiteracy or a physical impairment.
7. The Investigator concludes that the anticipated vaccination site (deltoid area) is not suitable for adverse event assessment
* Or legal adult according to local law. Participants in NE limited to individuals age 19-69 years due to age of majority laws in NE.
Clareo Health | Safety and Efficacy of Two Tetanus-Diphtheria Vaccines for a Donor Hyper Immunization Program
