Immunogenicity and Safety of Vaccine Against Tetanus and Diphtheria.

Phase 3

Active, not recruiting

• Conditions: Tetanus; Diphtheria
• Interventions: Biological: Clodivac; Biological: Td-Impfstoff Merieux

• Registration Number: NCT05480462
• Lead Sponsor: IBSS Biomed S.A.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-27
• Study First Submitted QC: 2022-07-27
• Study First Posted: 2022-07-29
• Study Start: 2022-12-12
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-02
• Last Update Posted: 2024-02-05
• Primary Completion: 2024-03-04
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clodivac	Clodivac	-
Td-Impfstoff Merieux	Td-Impfstoff Merieux	-

Primary Outcome Measures

Name	Time	Method
Seroconversion	28 days	The primary endpoint is the seroconversion in 28 days follow-up. The proportion of subjects complying the positive criteria of seroconversion will be calculated.

Secondary Outcome Measures

Name	Time	Method
The ratio of geometric mean concentrations (GMC) of post-vaccination tetanus antibodies and diphtheria antibodies between test and reverence.	28 days	1. The ratio of geometric mean concentrations (GMC) of post-vaccination tetanus antibodies between test and reference vaccine in 28 days FU.; 2. The ratio of geometric mean concentrations (GMC) of post-vaccination diphtheria antibodies between test and reference va1. The ratio of geometric mean concentrations (GMC) of post-vaccination tetanus antibodies between test and reference vaccine in 28 days FU.

Trial Locations

Locations (2)

SPZOZ w Bochni Szpital Powiatowy im. bł. M. Wieckiej; 🇵🇱 Bochnia, Poland

Krakowski Szpital Specjalistyczny im. Jana Pawła II; 🇵🇱 Kraków, Poland