NCT02673255 is a Phase 1 clinical trial of Tetanus and Diphtheria (Td) Vaccine in Healthy, sponsored by Biomat USA, Inc..

Who is sponsoring NCT02673255?

NCT02673255 is sponsored by Biomat USA, Inc..

What drugs are being tested in NCT02673255?

Interventions in NCT02673255: Tetanus and Diphtheria (Td) Vaccine.

Is NCT02673255 still recruiting?

NCT02673255 is currently completed. Last updated 20 July 2021.

Last reviewed 2021-07-20 · How we verify

NCT02673255

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 20 July 2021

What this trial tests

Phase 1 trial testing Tetanus and Diphtheria (Td) Vaccine in Healthy in 300 participants. Completed in 29 July 2019.

Timeline

22 August 2016

Primary endpoint
29 July 2019

29 July 2019

Quick facts

Lead sponsor	Biomat USA, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	300
Start date	22 August 2016
Primary completion	29 July 2019
Estimated completion	29 July 2019
Sites	4 locations across United States

Drugs / interventions tested

Tetanus and Diphtheria (Td) Vaccine

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Biomat USA, Inc.

Who can join

Adults 18 to 69, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Many plasma donation centers have Tetanus immunization programs that are implemented in order to collect plasma with high levels of tetanus antibodies. The immunization program requires participants to receive multiple tetanus vaccinations over a period of time with the goal of hyper-immunizing them to tetanus. Their antibody-rich plasma is then used to manufacture a tetanus immunoglobulin product which helps with the prophylaxis and treatment of tetanus disease. The Tetanus vaccine previously used for these programs is no longer being manufactured. Therefore, we must evaluate the safety and efficacy of a different vaccine when used for this purpose. The only other FDA approved Tetanus vaccines currently available for adults in the US are combination vaccines that also immunize against Diphtheria and/or Pertussis. In this study, the investigators will evaluate two vaccines that are combinations of Tetanus and Diphtheria (Td). Investigators will not evaluate any vaccines containing Pertussis antigen. The vaccines to be evaluated are manufactured by MassBiologics and Sanofi Pasteur (Tenivac). The package insert for these vaccines indicates they should be administered to previously vaccinated people once every 10 years. However, this study will evaluate whether they are safe and effective for dosing every 90 days. The investigators hypothesize that at least 25% of study subjects will have a positive response to at least one of the five planned doses. Each vaccine will be evaluated separately.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02673255 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Biomat USA, Inc.
Last refreshed: 20 July 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02673255.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing