Immunogenicity and Safety of Vaccine Against Tetanus and Diphtheria.

NCT05480462 | Active Not Recruiting Phase 3

• 1 other identifier: 21-BIO-0002
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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

Keywords

Vaccine; Booster

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The ratio of geometric mean concentrations (GMC) of post-vaccination tetanus antibodies and diphtheria antibodies between test and reverence.

  28 days

Study Arms (2)

Clodivac

EXPERIMENTAL

Biological: Clodivac

Td-Impfstoff Merieux

ACTIVE COMPARATOR

Biological: Td-Impfstoff Merieux

Interventions

Clodivac BIOLOGICAL

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

Clodivac

Td-Impfstoff Merieux BIOLOGICAL

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

Td-Impfstoff Merieux

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IBSS Biomed S.A.: lead

Study Sites (2)

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

Bochnia, Poland

Location

Krakowski Szpital Specjalistyczny im. Jana Pawła II

Krakow, Poland

Location

MeSH Terms

Conditions

Diphtheria; Tetanus

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Clostridium Infections

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2022
• First Posted: July 29, 2022
• Study Start: December 12, 2022
• Primary Completion: March 4, 2024
• Study Completion: June 1, 2024
• Last Updated: February 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2)