A randomised, comparative, multicentre clinical trial of the immunogenicity and safety of Tdap-IPV vaccine (REPEVAX) and a tetanus monovalent vaccine in healthy adults 18 years of age and older

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 456

Inclusion Criteria

Subjects have to meet all the following criteria to be eligible for inclusion:
1. Healthy adults aged =18 years,
2. Last booster with a T-containing vaccine received 5 to 10 years prior to the administration of the study vaccine (documented by written evidence),
3. Negative urine pregnancy test for female subjects of child-bearing potential. A female subject who is of reproductive potential must agree to remain abstinent or use (or have her partner use) acceptable methods of birth control during the study period,
4. Subject affiliated to a health social security system (for France only),
5. Subject having signed the informed consent form prior to participation in the study,
6. Subject able to attend all scheduled visits and to comply with all study procedures.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects meeting at least one of the following criteria will be ineligible for inclusion:
1. Acute severe illness or fever (=38.0°C) within the last 3 days,
2. Hypersensitivity or known allergy to one of the components of one of the study vaccines (including formaldehyde, streptomycin, neomycin, polymyxin B, or glutaraldehyde),
3. Anaphylactic or other allergic reactions to a previous dose of a vaccine containing diphtheria or tetanus toxoids or poliomyelitis viruses or pertussis (acellular or whole cell),
4. Guillain Barré syndrome or neuropathy of brachial plexus following a previous vaccination with a tetanus toxoid containing vaccine,
5. Known encephalopathy after receipt of a pertussis vaccine or neurological disorders after an injection with the same antigens,
6. Progressive or unstable neurological disorder, uncontrolled seizures or progressive
encephalopathy not stabilized,
7. Known malignant disease;
Note: Subjects with prostate or breast cancer who are not on chemotherapeutic drugs (other than hormone blocking drugs), subjects with skin cancer who are not receiving radiation therapy or chemotherapy and subjects with a history of other malignancies who have been disease-free for at least 5 years will be eligible for enrolment.
8. Immunosuppressive therapy:
- High dose (= 20 mg/day prednisone equivalent) systemic (= 14 days) corticosteroid
treatment daily or on alternate day within the last 28 days (inhaled corticosteroids
allowed),
- Chemotherapeutic agents used to treat cancer or other conditions,
- Treatments associated with organ or bone marrow transplantation.
9. Immune dysfunction caused by a medical condition, or any other cause (e.g. congenital immunodeficiency, human immunodeficiency virus (HIV) infection, organ or bone marrow transplantation, leukemia, lymphoma, Hodgkin’s disease, multiple myeloma or generalized malignancy),
10. Known severe thrombocytopenia or coagulation disorder contraindicating an intramuscular injection,
11. Administration of blood products including immunoglobulins within the last 90 days or planned before Visit 3,
12. Recent administration of a live vaccine (=28 days) or an inactivated vaccine (=14 days) or vaccination planned before Visit 3,
13. For female subjects, pregnancy (positive pregnancy test before first blood sample) or breast-feeding through Visit 3,
14. Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalised without his/her consent,
15. Planned participation in another clinical study during the present study period,
16. Volunteer having been paid more than 4 500€ to take part in biomedical research during the previous 12 months (for France only).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate that a booster dose of Tdap-IPV vaccine is as immunogenic as a booster dose Tetanus monovalent vaccine in terms of anti-tetanus seroprotection rate (defined as percentage of subjects with anti-tetanus antibody titre (measured by Enzyme-Linked ImmunoSorbent Assay (ELISA) =0.1 IU/mL) 10 days after vaccination.;Secondary Objective: To describe the Geometric Mean Titre (GMT) for tetanus antibodies in both groups at Day 0, Day 10 and Day 28 and the seroprotection rate at Day 28.<br><br>To describe the safety profile of the two vaccines (descriptive objective).;Primary end point(s): The primary endpoint will be the anti-tetanus seroprotection rate (defined as percentage of subjects with anti-tetanus antibody titre (ELISA) =0.1 IU/mL) 10 days after vaccination.

Secondary Outcome Measures

Name	Time	Method

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