Immunogenicity and Safety of Vaccine Against Tetanus and Diphtheria.

NCT ID: NCT05480462

Last Updated: 2024-02-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-12
• Study Completion Date: 2024-06-30

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.

Conditions

Diphtheria; Tetanus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Clodivac

Group Type: EXPERIMENTAL

Clodivac

Intervention Type: BIOLOGICAL

A dose of 0.5 ml should be administered intramuscularly into deltoid muscle.

Td-Impfstoff Merieux

Group Type: ACTIVE_COMPARATOR

Td-Impfstoff Merieux

Intervention Type: BIOLOGICAL

One dose (0.5 ml) intramuscular, preferably in the deltoid muscle of the upper arm.

Interventions

Clodivac

A dose of 0.5 ml should be administered intramuscularly into deltoid muscle.

Intervention Type: BIOLOGICAL

Td-Impfstoff Merieux

One dose (0.5 ml) intramuscular, preferably in the deltoid muscle of the upper arm.

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

IBSS Biomed S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

SPZOZ w Bochni Szpital Powiatowy im. bł. M. Wieckiej

Bochnia, , Poland

Krakowski Szpital Specjalistyczny im. Jana Pawła II

Krakow, , Poland

Countries

Poland

Other Identifiers

21-BIO-0002

Identifier Type: -

Identifier Source: org_study_id