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: A subject must meet all the following criteria in order to be included in the study: 1. Age > 4 years and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A subject who meets any of the following criteria will not be eligible for inclusion in the study: 1. Known or suspected primary or acquired disease of the immune system, including autoimmune diseases such as rheumatoid arthritis or inflammatory bowel disease. 2. Any unstable, significant underlying chronic disease, including, but not limited to, malignancy; cardiopulmonary disease; renal, endocrinologic, or hepatic dysfunction; or hematologic disorder. 3. Receipt of immunosuppressive therapy for chronic immune disorders or malignancy. 4. Daily use of oral or inhaled corticosteroids for any medical conditions: e.g. daily systemic prednisone > 1 mg/kg (However, topical corticosteroids or inhaled corticosteroids that are taken on an occasional basis, or for 38.0 degrees C 2. Known or suspected acute infectious respiratory illness, with one or more of the following active symptoms and signs: rhinorrhea, new cough, pharyngitis, and respiratory problems (e.g., wheezing, shortness of breath).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To compare the immunogenicity of the tetanus and lower dose diphtheria toxoids of ADACEL™ with QUADRACEL™ when given as a fifth dose. 2. To compare the redness, swelling, pain, and fever rates after the ADACEL™ dose with the rates of these adverse events observed after the QUADRACEL™ dose when given as a fifth dose. ;Secondary Objective: 1. To assess the immunogenicity of diphtheria and tetanus toxoids in terms of GMTs and four-fold rises in both treatment groups. 2. To assess the immunogenicity of all pertussis antigens in terms of GMTs and four-fold rises in both treatment groups. ;Primary end point(s): Expected Response Levels for Diphtheria and Tetanus clinical endpoints: Antigen Primary Clinical Endpoints Expected Response Levels Power (95% CI with N=600) Diphtheria IU/mL % > = 0.1 98% 98% Tetanus IU/mL % > = 0.1 99% 98% ;Timepoint(s) of evaluation of this end point: Safety Post-Vaccination: Day 0 to day 14 post-vaccination or until resolution and until study completion (4–6 weeks after vaccination). Immunogenicity Pre-Vaccination and Post-Vaccination 4 to 6 weeks: Antibody levels for diphtheria, tetanus, and pertussis | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety: The occurrence, intensity and relationship to vaccination of adverse events (AEs) reported within the first 24 hours and 72 hours.;Timepoint(s) of evaluation of this end point: Severe Redness (>= 3.5 cm) - Within first 24 hours Any Redness - Within first 72 hours Severe Swelling (>= 3.5 cm) - Within first 24 hours Any Swelling - Within first 72 hours Pain - Within first 72 hours Fever (>= 38 degrees C) - Within first 24 hours | — |
Countries
Canada
Contacts
Public ContactOladayo Oyelola
SANOFI PASTEUR
Outcome results
None listed