A randomised, comparative, multicentre clinical trial of the immunogenicity and safety of Tdap-IPV vaccine (REPEVAX) and a tetanus monovalent vaccine in healthy adults 18 years of age and older

Sanofi Pasteur MSD S.N.C.0 sites0 target enrollmentMarch 31, 2009

Overview

No summary available.

Registry

who.int

Start Date

March 31, 2009

End Date

December 8, 2009

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Sanofi Pasteur MSD S.N.C.

•Subjects have to meet all the following criteria to be eligible for inclusion:
•1\. Healthy adults aged \=18 years,
•2\. Last booster with a T\-containing vaccine received 5 to 10 years prior to the administration of the study vaccine (documented by written evidence),
•3\. 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,
•4\. Subject affiliated to a health social security system (for France only),
•5\. Subject having signed the informed consent form prior to participation in the study,
•6\. Subject able to attend all scheduled visits and to comply with all study procedures.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

•Subjects meeting at least one of the following criteria will be ineligible for inclusion:
•1\. Acute severe illness or fever (\=38\.0°C) within the last 3 days,
•2\. Hypersensitivity or known allergy to one of the components of one of the study vaccines (including formaldehyde, streptomycin, neomycin, polymyxin B, or glutaraldehyde),
•3\. 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),
•4\. Guillain Barré syndrome or neuropathy of brachial plexus following a previous vaccination with a tetanus toxoid containing vaccine,
•5\. Known encephalopathy after receipt of a pertussis vaccine or neurological disorders after an injection with the same antigens,
•6\. Progressive or unstable neurological disorder, uncontrolled seizures or progressive
•encephalopathy not stabilized,
•7\. 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 enrolment.