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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05480462
Other study ID # 21-BIO-0002
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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