UnknownPhase 3

Immunogenicity and Safety of Vaccine Against Tetanus and Diphtheria.

Poland200 participantsStarted 2022-12-12

Plain-language summary

A single blind, randomized, comparative, multicentre clinical trial of the immunogenicity and safety of booster immunization with bivalent vaccine against tetanus and diphtheria CLODIVAC (IBSS BIOMED S.A.) and Td-Impfstoff Mérieux (Sanofi Pasteur) in healthy adults.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Approved informed consent.
✓. Men and women aged 18- 65 years.
✓. Written confirmation on previous immunization against diphtheria and tetanus not older than 16 years and not younger than 4 years.

Exclusion criteria

✕. Subject with acute infectious diseases.
✕. Subject allergic to any of the substances of the IMP administered in clinical trial.
✕. Subject with Guillain-Barré syndrome or neuropathy, an anaphylactic or other allergic reactions after previous vaccination against tetanus or diphtheria.
✕. Subject with primary or secondary immunodeficiency (e.g. congenital immunodeficiency, HIV infection, organ or bone marrow transplantation, leukemia, lymphoma, Hodgkin's disease, multiple myeloma, generalized malignancy, drugs or other causes induced immunodeficiency).
✕. Subject with progressive or unstable neurological disorder.
✕. Subject with severe thrombocytopenia or any coagulation disorder not allowing the intramuscular administration.
✕. Subject with blood product treatment, including immunoglobulins within the last 90 days prior to study entry.
✕. Subject vaccinated less than 14 days inactivated or live vaccine prior to study entry.

What they're measuring

Seroconversion

Timeframe: 28 days

Trial details

NCT IDNCT05480462

SponsorIBSS Biomed S.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-03-04

View on ClinicalTrials.gov More Diphtheria trials