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

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

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.

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