DRKS00000180
Completed
Phase 3
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 - RPV02C
Sanofi Pasteur MSD0 sites456 target enrollmentOctober 7, 2009
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- tetanus
- Sponsor
- Sanofi Pasteur MSD
- Enrollment
- 456
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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:
- •o subjects with prostate or breast cancer who are not on chemotherapeutic drugs (other than hormone blocking drugs),
- •o subjects with skin cancer who are not receiving radiation therapy or chemotherapy, and
- •o subjects with a history of other malignancies who have been disease\-free for at least 5 years will be eligible for enrollment
Outcomes
Primary Outcomes
Not specified
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