Study Comparing a Tdap-IPV Combined Vaccine With a Tetanus Monovalent Vaccine in Healthy Adults

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate that a combined adult Tdap-IPV vaccine (REPEVAX®) will provide similar rapid antibody responses against tetanus toxoid as a tetanus toxoid vaccine alone in healthy adults.

Official Title
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A Randomised, Comparative, Multicentre Clinical Trial of the Immunogenicity and Safety of Tdap-IPV Vaccine and a Tetanus Monovalent Vaccine in Healthy Adults 18 Years of Age and Older

Conditions
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Healthy

Intervention / Treatment
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* Biological: REPEVAX
* Biological: Monovalent Tetanus vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults aged ≥18 years Last booster with a T-containing vaccine received 5 to 10 years prior to the administration of the study vaccine (documented by written evidence) Subject with vaccination history of a primary immunisation with a tetanus, diphtheria and poliomyelitis containing vaccine as recommended in the local vaccination calendar 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 Subject having signed the informed consent form prior to participation in the study Exclusion Criteria: Acute severe illness or fever (>=38.0°C) within the last 3 days Hypersensitivity or known allergy to one of the components of one of the study vaccines (including formaldehyde, streptomycin, neomycin, polymyxin B, or glutaraldehyde) 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) Guillain Barré syndrome or neuropathy of brachial plexus following a previous vaccination with a tetanus toxoid containing vaccine Known encephalopathy after receipt of a pertussis vaccine or neurological disorders after an injection with the same antigens Progressive or unstable neurological disorder, uncontrolled seizures or progressive encephalopathy not stabilized 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 enrollment 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 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) Known severe thrombocytopenia or coagulation disorder contraindicating an intramuscular injection Administration of blood products including immunoglobulins within the last 90 days or planned before Visit 3 Recent administration of a live vaccine (≤28 days) or an inactivated vaccine (≤14 days) or vaccination planned before Visit 3 For female subjects, pregnancy (positive pregnancy test before first blood sample) or breast-feeding through Visit 3 Planned participation in another clinical study during the present study period

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: REPEVAX<br> | Biological: REPEVAX<br>* 1 dose of 0.5 mL at Day 0<br>|
| Active Comparator: Monovalent tetanus vaccine<br> | Biological: Monovalent Tetanus vaccine<br>* 1 dose of 0.5 mL at Day 0<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-tetanus seroprotection rate (defined as the percentage of subjects with anti-tetanus antibody titre (ELISA) ≥ 0.1 IU/mL) |  | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Titre (GMT) for tetanus antibodies in both groups |  | Day 0, Day 1 and Day 28 | 
| The anti-tetanus seroprotection rate (antibody titre ≥ 0.1 IU/mL in ELISA) |  | Day 28 | 
| Percentage of subjects with immediate reactions, solicited injection-site reactions, systemic reactions and unsolicited adverse events |  | D0 to Day 7 | 
| Percentage of subjects with serious adverse events |  | D0 to Day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tetanus Vaccine, Tdap-IPV vaccine