A Study to Describe the Safety Profile and Compare the Immune Response of 4 Different Formulations of an Investigational Tdap Vaccine When Compared to Licensed Tdap Vaccine in Young Adults in Canada
- Conditions
- Diphtheria Immunisation (Healthy Volunteers)Tetanus Immunisation (Healthy Volunteers)Pertussis Immunisation (Healthy Volunteers)
- Registration Number
- NCT03958799
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- Brief Summary
The primary objectives of this study are:
* To describe the safety profile of each of the investigational vaccine formulations for all participants
* To describe the humoral and cell-mediated immune responses to all of the investigational vaccine formulations
* To evaluate the dose response to vaccine components
* To describe the magnitude, quality, and longevity of immune responses to each of the investigational vaccine formulations
- Detailed Description
Study duration per participant is approximately 1 year, which will include a safety follow-up contact at 12 months after vaccination
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 71
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Number of participants reporting immediate adverse events (AEs) Within 30 minutes post-vaccination AEs, including those related to the product administered
Number of participants reporting unsolicited AEs Within 30 days post-vaccination AEs other than solicited reactions
Number of participants reporting Grade 2 and Grade 3 laboratory parameter abnormalities Within 60 days post-vaccination Haematological and biochemical laboratory parameters
GMCs of anti-tetanus toxoid immunoglobulins From Day 0 to Day 360 Anti-tetanus toxoid total immunoglobulins concentration will be measured by MSD ECL
Number of participants reporting serious adverse events (SAEs) Up to 12 months post-vaccination SAEs, including adverse event of special interest (AESIs)
Number of participants reporting medically attended adverse events (MAAEs) Up to 12 months post-vaccination MAAE: a new onset or a worsening of a condition that prompts the participant to seek unplanned medical advice at a physician's office or emergency department
Geometric mean concentrations (GMCs) of anti-pertussis antigen immunoglobulins From Day 0 to Day 360 Anti-pertussis antigen immunoglobulins concentration will be measured by mesoscale discovery electrochemiluminescence (MSD ECL)
Geometric means of antigen-specific cells From Day 0 to Day 360 Antigen specific cells will be measured by FLUOROSPOT
Number of participants reporting solicited injection sites or systemic reactions Within 7 days post-vaccination Solicited reaction: adverse reaction prelisted in the case report book (CRB) Injection site reactions: pain, erythema, swelling Systemic reactions: fever, headache, malaise, myalgia, arthralgia, chills
Number of participants reporting adverse events of special interest (AESIs) Up to 12 months post-vaccination AESIs are reported until the end of the safety follow-up period
GMCs of anti-diphtheria toxoid immunoglobulins From Day 0 to Day 360 Anti-diphtheria toxoid total immunoglobulins concentration will be measured by MSD ECL
Percentages of antigen-specific cells From Day 0 to Day 360 Antigen specific cells will be measured by FLUOROSPOT
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Investigational Site Number 1240006
🇨🇦Halifax, Canada
Investigational Site Number 1240009
🇨🇦Pierrefonds, Canada
Investigational Site Number 1240004
🇨🇦Quebec, Canada
Investigational Site Number 1240005
🇨🇦Sherbrooke, Canada
Investigational Site Number 1240003
🇨🇦Truro, Canada
Investigational Site Number 1240006🇨🇦Halifax, Canada