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

Sanofi

Status and phase

Completed

Phase 3

Conditions

Healthy

Treatments

Biological: REPEVAX

Biological: Monovalent Tetanus vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00928785

RPV02C

Details and patient eligibility

About

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.

Enrollment

52 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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