Clinical trial NCT05480462: Immunogenicity and Safety of Vaccine Against Tetanus and Diphtheria.
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Diphtheria
Tetanus
Keywords: Vaccine
Booster
Lead sponsor: IBSS Biomed S.A.
Sponsor class: INDUSTRY
First posted: 2022-07-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Seroconversion
timeFrame: 28 days
Secondary outcomes:
measure: The ratio of geometric mean concentrations (GMC) of post-vaccination tetanus antibodies and diphtheria antibodies between test and reverence.
timeFrame: 28 days
Other outcomes:
Locations:
city: Bochnia
country: Poland
facility: SPZOZ w Bochni Szpital Powiatowy im. bł. M. Wieckiej
city: Kraków
country: Poland
facility: Krakowski Szpital Specjalistyczny im. Jana Pawła II
Study officials:
References: