Immunogenicity and Safety of Vaccine Against Tetanus and Diphtheria. (Clodivac)

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.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Tetanus; Diphtheria
• Intervention / Treatment: Biological: Clodivac; Biological: Td-Impfstoff Merieux

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 3

Contacts and Locations

Study Locations

• Poland
  • Bochnia, Poland
    • SPZOZ w Bochni Szpital Powiatowy im. bł. M. Wieckiej
  • Kraków, Poland
    • Krakowski Szpital Specjalistyczny im. Jana Pawła II

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: IBSS Biomed S.A.

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2022
• Primary Completion (Estimated): March 4, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: July 27, 2022
• First Submitted That Met QC Criteria: July 27, 2022
• First Posted (Actual): July 29, 2022

Study Record Updates

• Last Update Posted (Estimated): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Booster; Vaccine
• Additional Relevant MeSH Terms: Metabolic Diseases; Nervous System Diseases; Infections; Neurologic Manifestations; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Neuromuscular Manifestations; Actinomycetales Infections; Clostridium Infections; Hypocalcemia; Calcium Metabolism Disorders; Corynebacterium Infections; Tetanus; Diphtheria; Tetany
• Other Study ID Numbers: 21-BIO-0002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No