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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REPEVAX | Experimental |
| |
| Monovalent tetanus vaccine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REPEVAX | Biological | 1 dose of 0.5 mL at Day 0 |
| |
| Monovalent Tetanus vaccine |
| 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 |
| 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 | |
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Inclusion Criteria:
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:
Immunosuppressive therapy:
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
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Gabriel Montpied - CHU Clermont-Ferrand | Clermont-Ferrand | 63000 | France | |||
| Hôpital St Eloi |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23032160 | Derived | Laurichesse H, Zimmermann U, Galtier F, Launay O, Duval X, Richard P, Sadorge C, Soubeyrand B. Immunogenicity and safety results from a randomized multicenter trial comparing a Tdap-IPV vaccine (REPEVAX(R)) and a tetanus monovalent vaccine in healthy adults: new considerations for the management of patients with tetanus-prone injuries. Hum Vaccin Immunother. 2012 Dec 1;8(12):1875-81. doi: 10.4161/hv.22083. Epub 2012 Oct 2. |
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| ID | Term |
|---|---|
| D013742 | Tetanus |
| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| Biological |
1 dose of 0.5 mL at Day 0 |
|
| 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 |
| Montpellier |
| 34295 |
| France |
| Groupe Hospitalier Cochin - Saint-Vincent de Paul | Paris | 75014 | France |
| Hôpital Bichat Claude Bernard | Paris | 75018 | France |
| Heilbronn | 74072 | Germany |
| Künzig | 94550 | Germany |
| Nettersheim | 53947 | Germany |
| Offenbach | 63071 | Germany |
| Reichenbach/Vogtland | 8468 | Germany |
| D007239 | Infections |