Immunogenicity and Safety of Vaccine Against Tetanus and Diphtheria. (Clodivac)

IBSS Biomed

Status and phase: Active, not recruiting; Phase 3

Conditions: Diphtheria; Tetanus

Treatments: Biological: Td-Impfstoff Merieux; Biological: Clodivac

Study type: Interventional

Funder types: Industry

Identifiers

NCT05480462

21-BIO-0002

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Subject with acute infectious diseases.
2. Subject allergic to any of the substances of the IMP administered in clinical trial.
3. Subject with Guillain-Barré syndrome or neuropathy, an anaphylactic or other allergic reactions after previous vaccination against tetanus or diphtheria.
4. 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).
5. Subject with progressive or unstable neurological disorder.
6. Subject with severe thrombocytopenia or any coagulation disorder not allowing the intramuscular administration.
7. Subject with blood product treatment, including immunoglobulins within the last 90 days prior to study entry.
8. Subject vaccinated less than 14 days inactivated or live vaccine prior to study entry.
9. Pregnant woman and breastfeeding (anamnestically).
10. Subject incapable of cooperation.
11. Alcohol or drug abuse.
12. Subject currently participating in another clinical trial or in drug evaluation, within 4 weeks prior to study entry.
13. Subjects requiring vaccination against tetanus after severe injury.
14. Any other condition that in the Investigator's opinion may affect the safety of the test participant or the integrity of data obtained during the study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Clodivac

Experimental group

Treatment:

Biological: Clodivac

Td-Impfstoff Merieux

Active Comparator group

Treatment:

Biological: Td-Impfstoff Merieux