Tetanus Clinical Trial - Tdap Vaccine Safety for Plasma Donors

Status Completed

Clinical Trial Summary

This is a prospective, open label, single-arm, multi-center, Phase 1 study measuring the safety and tetanus antibody responses to Tdap vaccine administered to plasma donors every 3 months ±1 week for 12 months (5 vaccinations) with a 6 month follow-up after the last vaccination. After obtaining informed consent and screening for eligibility including plasmapheresis donor eligibility, subjects will have other baseline assessments performed and if eligible, will receive the scheduled vaccinations, will be assessed for adverse events (AEs) and have plasma samples collected for antibody titers each month thereafter for 11 months, and then at 1 and 6 months after the last vaccination. As these subjects are participating in a standard donor plasmapheresis donor program, assessments for donor eligibility and routine plasmapheresis will be performed; however, only the data specifically required to meet the objectives of this study will be collected.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Tetanus

Clinical Trial Details

NCT number	NCT04142983
Study type	Interventional
Source	GCAM Inc.
Contact
Status	Completed
Phase	Phase 2/Phase 3
Start date	February 3, 2020
Completion date	November 16, 2021

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