Immunogenicity and Safety of Vaccine Against Tetanus and Diphtheria.

Tetanus Clinical Trial

— Clodivac  

Official title:

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05480462
• Other study ID #: 21-BIO-0002
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: December 12, 2022
• Est. completion date: June 2024

Study information

• Verified date: February 2024
• Source: IBSS Biomed S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: June 2024
• Est. primary completion date: March 4, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diphtheria
• Tetanus

Intervention

Biological:
• Clodivac
A dose of 0.5 ml should be administered intramuscularly into deltoid muscle.
• Td-Impfstoff Merieux
One dose (0.5 ml) intramuscular, preferably in the deltoid muscle of the upper arm.

Locations

Country	Name	City	State
Poland	SPZOZ w Bochni Szpital Powiatowy im. bl. M. Wieckiej	Bochnia
Poland	Krakowski Szpital Specjalistyczny im. Jana Pawla II	Kraków

Sponsors (1)

Lead Sponsor	Collaborator
IBSS Biomed S.A.

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seroconversion	The primary endpoint is the seroconversion in 28 days follow-up. The proportion of subjects complying the positive criteria of seroconversion will be calculated.	28 days
Secondary	The ratio of geometric mean concentrations (GMC) of post-vaccination tetanus antibodies and diphtheria antibodies between test and reverence.	The ratio of geometric mean concentrations (GMC) of post-vaccination tetanus antibodies between test and reference vaccine in 28 days FU.; 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.	28 days