Tdap Vaccine Safety for Plasma Donors

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-03

Study Completion Date

2021-11-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Immunogenicity Study of Tdap Vaccinations for Plasma Donors

NCT05662852

Tetanus, Diphtheria and Acellular Pertussis Vaccination

COMPLETED PHASE2

Safety and Efficacy of Two Tetanus-Diphtheria Vaccines for a Donor Hyper Immunization Program

NCT02673255

Healthy

COMPLETED PHASE1

Study of Adacel® Vaccine Administered to Persons 10 Years of Age

NCT01311557

Tetanus Diphtheria Pertussis

COMPLETED PHASE4

Descriptive, Post-marketing, Passive Surveillance Safety Study of ADACEL™ Vaccine

NCT00258882

Pertussis

COMPLETED

A Combined Tdap Vaccine Used As A Booster Compared To Licensed Td Vaccine

NCT00109330

Diphtheria Tetanus Acellular Pertussis

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tetanus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Study Group

Participants will receive a single dose of Tdap vaccine (Adacel) every 3 months for a total of 5 immunizations over a period of 12 months.

Group Type EXPERIMENTAL

Adacel

Intervention Type BIOLOGICAL

0.5 mL, Intramuscular

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Adacel

0.5 mL, Intramuscular

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Tdap Vaccine

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male or female ages 18 to 63 years
* Females of childbearing potential who agree to employ adequate birth control measures during the study
* Signed the informed consent form (ICF)
* Met all of the criteria required by GCAM to be a Normal Source Plasma donor
* Subject is not participating in any other immunization program

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 (e.g., thimerosal, latex, etc.)
* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

63 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes