Comparative study of immune response and safety of booster immunisation with two vaccines against tetanus and diphtheriae (VACDITE and IMOVAX D.T. ADULT) in health adults.

Phase 1

• Conditions: Verification of immune response after booster immunisation with one dose of vaccine against tetanus and diphtheriae; MedDRA version: 20.0Level: LLTClassification code 10054183Term: Tetanus immunizationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 20.0Level: PTClassification code 10054129Term: Diphtheria immunisationSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2018-001604-10-SK
• Lead Sponsor: BIODRUG s.r.o.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-20
• Study Completion: 2018-11-29
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1.Subject provides written informed consent with the study participation
2.Subjects must have written confirmation on previous immunisation against tetanus and diphtheriae not later than 15.9 years and not early than 9.9 years
3.Men and women aged 24.1- 64.9 years

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Subject with acute infectious diseases.
2.Subject allergic to any of the substances of the investigational medicinal product administered in clinical trial (i.e., test and reference vaccine).
3.Subject with Guillain-Barré syndrome or neuropathy, some anaphylactic or other allergic reactions after previous vaccination against tetanus and diphtheriae.
4.Pregnant woman and breastfeeding (anamnestically).
5.Subject with primary or secondary immunodeficiency (e.g. congenital immunodeficiency, HIV infection, organ or bone marrow transplantation, leukaemia, lymphoma, Hodgkin's disease, multiple myeloma, generalised malignancy, drugs or other causes induced immunodeficiency).
6.Subject with progressive or unstable neurological disorder.
7.Subject with severe thrombocytopenia or any coagulation disorder not allowing the intramuscular use.
8.Subject with blood product treatment, including immunoglobulins within the last 90 days prior to study entry.
9.Subject vaccinated less than 30 days inactivated or live vaccine prior to study entry.
10.Subject - pregnant or breast feeding women. Women of child bearing potential must have a negative urine or serum pregnancy test prior to enrolment.*
11.Subject unable to understand consent or follow study protocol.
12.Subject addicted to alcohol or drugs.
13.Subject currently participating in another clinical trial of a medication or in a trial that has taken place in the last 4 weeks.
14.A subject requiring tetanus vaccination after an injury

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified