Immunogenicity and Safety of Vaccine Against Tetanus and Diphtheria.

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Diphtheria, Tetanus

Intervention / Treatment
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* Biological: Clodivac
* Biological: Td-Impfstoff Merieux


Participation Criteria
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Eligibility Criteria
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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. Pregnant woman and breastfeeding (anamnestically). Subject incapable of cooperation. Alcohol or drug abuse. Subject currently participating in another clinical trial or in drug evaluation, within 4 weeks prior to study entry. Subjects requiring vaccination against tetanus after severe injury. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clodivac<br> | Biological: Clodivac<br>* A dose of 0.5 ml should be administered intramuscularly into deltoid muscle.<br>|
| Active Comparator: Td-Impfstoff Merieux<br> | Biological: Td-Impfstoff Merieux<br>* One dose (0.5 ml) intramuscular, preferably in the deltoid muscle of the upper arm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaccine, Booster