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

Phase 3

• Conditions: A35; tetanus; Other tetanus

• Registration Number: DRKS00000180
• Lead Sponsor: Sanofi Pasteur MSD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-07
• Study Completion: 2009-12-08
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 456

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
*

Immunosuppressive therapy:
o 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)
o Chemotherapeutic agents used to treat cancer or other conditions
o 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

Study & Design

• Study Type: interventional
• Study Design: Not specified