Healthy
Conditions
Keywords
Tetanus Vaccine, Tdap-IPV vaccine
Brief 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.
Interventions
BIOLOGICALREPEVAX
1 dose of 0.5 mL at Day 0
BIOLOGICALMonovalent Tetanus vaccine
1 dose of 0.5 mL at Day 0
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
France, Germany
Outcome results
None listed