Active immunization against tetanus, diphtheria and pertussis MedDRA version: 18.1 Level: PT Classification code 10054129 Term: Diphtheria immunisation System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 18.1 Level: PT Classification code 10069577 Term: Pertussis immunisation System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 18.1 Level: PT Classification code 10054131 Term: Tetanus immunisation System Organ Class: 10042613 - Surgical and
Conditions
Sponsors
Sanofi Pasteur Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participation in original Study Td9805 and the receipt of Tdap. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnancy or planning a pregnancy during the study period. 2. Known or suspected primary disease of the immune system (conditions suspected of having an immunologic component such as autoimmune diseases (rheumatoid arthritis or inflammatory bowel disease) will not be excluded unless they meet exclusion criterion 3 or are sufficiently clinically active to meet exclusion criterion 5). 3. Malignancy or receiving immunosuppressive therapy (e.g. daily systemic prednisone 1 mg/kg would be excluded. Participants who were taking topical and inhaled steroids could be included in the study as could participants on a “short course” of oral steroids, 5-7 days, as long as there were not two courses within the previous two week period.) 4. Receipt of any pertussis, diphtheria or tetanus containing vaccines within the previous 5 years. 5. Any significant underlying chronic disease, including malignancy, cardiopulmonary disease, renal or hepatic dysfunction. 6. Known impairment of neurologic function or seizure disorder of any etiology. 7. Personal history of physician diagnosed or laboratory confirmed pertussis disease within the previous 2 years. 8. Receipt of blood products or immunoglobulin within the previous 3 months. 9. Known or suspected allergy to any of the vaccines intended for use in the study. 10. Receipt of any vaccine within 2 weeks of receiving a study vaccine. 11. Daily use of non-steroidal anti-inflammatory drugs (NSAIDS).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To describe the antibody levels for tetanus, diphtheria and pertussis at 1 year, 3 years, 5 years and 10 years after vaccination with Tdap Vaccine.;Secondary Objective: Not applicable.;Primary end point(s): None. Only observational evaluation is performed.;Timepoint(s) of evaluation of this end point: Evaluated 10 years post vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable. ;Timepoint(s) of evaluation of this end point: Not applicable. | — |
Countries
Canada
Contacts
Public ContactOladayo Oyelola
SANOFI PASTEUR
Outcome results
None listed