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: Subjects who were enrolled in Groups 3, 4 and 5 of the original Study TC9704, received Tdap Vaccine and provided blood samples. Subjects in the other 2 study groups did not receive the investigational vaccine and thus were not followed for long-term immunogenicity (LTI) assessment. Inclusion criteria are the same as in the original study (Td9704): 1. Age =12 years but =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria are the same as in the original study (Td9704): 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, 8 years and 10 years after vaccination with Tdap Vaccine.;Secondary Objective: Not applicable.;Primary end point(s): None. Only observational evaluations were performed at 10 years post-vaccination for subjects who were adolescents at the time of vaccination (12-17 years of age) and adults at the time of vaccination (18-54 years of age), and adolescents and adults combined at the time of vaccination.;Timepoint(s) of evaluation of this end point: 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