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Study Comparing a Tdap-IPV Combined Vaccine With a Tetanus Monovalent Vaccine in Healthy Adults
Study Comparing a Tdap-IPV Combined Vaccine With a Tetanus Monovalent Vaccine in Healthy Adults
CompletedPhase 3
Sponsor: Sanofi Pasteur, a Sanofi Company
Conditions: Healthy
Interventions: REPEVAX, Monovalent Tetanus vaccine
Countries: France, Germany
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.
Eligibility overview
Sex: ALL
Age: 18 Years to —
Healthy volunteers: Yes
Study type: INTERVENTIONAL
Eligibility criteria
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
Locations (9)
- Clermont-Ferrand, France
- Montpellier, France
- Paris, France
- Paris, France
- Heilbronn, Germany
- Künzig, Germany
- Nettersheim, Germany
- Offenbach, Germany
- Reichenbach/Vogtland, Germany