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
Study duration per participant is approximately 1 year, which will include a safety follow-up contact at 12 months after vaccination
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
71
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
Investigational Site Number 1240006
Halifax, Canada
Investigational Site Number 1240009
Pierrefonds, Canada
Investigational Site Number 1240004
Québec, Canada
Investigational Site Number 1240005
Sherbrooke, Canada
Investigational Site Number 1240003
Truro, Canada
Number of participants reporting immediate adverse events (AEs)
AEs, including those related to the product administered
Time frame: Within 30 minutes post-vaccination
Number of participants reporting solicited injection sites or systemic reactions
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
Time frame: Within 7 days post-vaccination
Number of participants reporting unsolicited AEs
AEs other than solicited reactions
Time frame: Within 30 days post-vaccination
Number of participants reporting serious adverse events (SAEs)
SAEs, including adverse event of special interest (AESIs)
Time frame: Up to 12 months post-vaccination
Number of participants reporting medically attended adverse events (MAAEs)
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
Time frame: Up to 12 months post-vaccination
Number of participants reporting adverse events of special interest (AESIs)
AESIs are reported until the end of the safety follow-up period
Time frame: Up to 12 months post-vaccination
Number of participants reporting Grade 2 and Grade 3 laboratory parameter abnormalities
Haematological and biochemical laboratory parameters
Time frame: Within 60 days post-vaccination
Geometric mean concentrations (GMCs) of anti-pertussis antigen immunoglobulins
Anti-pertussis antigen immunoglobulins concentration will be measured by mesoscale discovery electrochemiluminescence (MSD ECL)
Time frame: From Day 0 to Day 360
GMCs of anti-diphtheria toxoid immunoglobulins
Anti-diphtheria toxoid total immunoglobulins concentration will be measured by MSD ECL
Time frame: From Day 0 to Day 360
GMCs of anti-tetanus toxoid immunoglobulins
Anti-tetanus toxoid total immunoglobulins concentration will be measured by MSD ECL
Time frame: From Day 0 to Day 360
Geometric means of antigen-specific cells
Antigen specific cells will be measured by FLUOROSPOT
Time frame: From Day 0 to Day 360
Percentages of antigen-specific cells
Antigen specific cells will be measured by FLUOROSPOT
Time frame: From Day 0 to Day 360
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