A Phase 3 interventional study of Clodivac and Td-Impfstoff Merieux in Diphtheria and Tetanus, sponsored by IBSS Biomed S.A.. Active, not recruiting at 2 sites in Poland. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-05.
Sponsored by IBSS Biomed S.A. · Phase 3, Interventional, and Prevention
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.
267 studies on the registry are indexed under Diphtheria; 17 are open to participants now.
This study's planned enrollment of 200 is below the median of 448 across 241 interventional studies indexed under Diphtheria.
Browse Diphtheria studies →IBSS Biomed S.A. is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological: Clodivac
Biological: Td-Impfstoff Merieux
A dose of 0.5 ml should be administered intramuscularly into deltoid muscle.
One dose (0.5 ml) intramuscular, preferably in the deltoid muscle of the upper arm.
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.
Time frame: 28 days
The ratio of geometric mean concentrations (GMC) of post-vaccination tetanus antibodies and diphtheria antibodies between test and reverence.
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.
Time frame: 28 days
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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IBSS Biomed S.A.