Status:
COMPLETED
Study Comparing a Tdap-IPV Combined Vaccine With a Tetanus Monovalent Vaccine in Healthy Adults
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00928785
Start Date
July 1 2009
End Date
December 1 2009
Last Update
September 11 2017
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
Hôpital Gabriel Montpied - CHU Clermont-Ferrand
Clermont-Ferrand, France, 63000
2
Hôpital St Eloi
Montpellier, France, 34295
3
Groupe Hospitalier Cochin - Saint-Vincent de Paul
Paris, France, 75014
4
Hôpital Bichat Claude Bernard
Paris, France, 75018