study comparing a tdap-ipv combined vaccine with a tetanus monovalent vaccine in healthy adults

Conditions: Healthy

Summary: 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 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

Keywords: tetanus vaccine tdap-ipv vaccine