Back to resultsImmunogenicity and Safety of Vaccine Against Tetanus and Diphtheria. (Clodivac)
Primary Purpose
Diphtheria, Tetanus
Status
Recruiting
Phase
Phase 3
Locations
Poland
Study Type
Interventional
Intervention
Clodivac
Td-Impfstoff Merieux
Sponsored by
About this trial
This is an interventional prevention trial for Diphtheria focused on measuring Vaccine, Booster
Eligibility Criteria
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.
Sites / Locations
- SPZOZ w Bochni Szpital Powiatowy im. bł. M. WieckiejRecruiting
- Krakowski Szpital Specjalistyczny im. Jana Pawła IIRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Clodivac
Td-Impfstoff Merieux
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05480462
Brief Title
Immunogenicity and Safety of Vaccine Against Tetanus and Diphtheria.
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 12, 2022 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IBSS Biomed S.A.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diphtheria, Tetanus
Keywords
Vaccine, Booster
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Clodivac
Arm Type
Experimental
Arm Title
Td-Impfstoff Merieux
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Clodivac
Intervention Description
A dose of 0.5 ml should be administered intramuscularly into deltoid muscle.
Intervention Type
Biological
Intervention Name(s)
Td-Impfstoff Merieux
Intervention Description
One dose (0.5 ml) intramuscular, preferably in the deltoid muscle of the upper arm.
Primary Outcome Measure Information:
Title
Seroconversion
Description
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
Secondary Outcome Measure Information:
Title
The ratio of geometric mean concentrations (GMC) of post-vaccination tetanus antibodies and diphtheria antibodies between test and reverence.
Description
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.
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
IBSS BIOMED S.A
Phone
+48123769308
Email
dm@biomed.pl
Facility Information:
Facility Name
SPZOZ w Bochni Szpital Powiatowy im. bł. M. Wieckiej
City
Bochnia
Country
Poland
Individual Site Status
Recruiting
Facility Name
Krakowski Szpital Specjalistyczny im. Jana Pawła II
City
Kraków
Country
Poland
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Immunogenicity and Safety of Vaccine Against Tetanus and Diphtheria.
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