Diphtheria Immunisation (Healthy Volunteers), Pertussis Immunisation (Healthy Volunteers), Tetanus Immunisation (Healthy Volunteers)
Conditions
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
Interventions
BIOLOGICALInvestigational Tdap vaccine Formulation B
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
BIOLOGICALInvestigational Tdap vaccine Formulation C
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
BIOLOGICALInvestigational Tdap vaccine Formulation A
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
BIOLOGICALInvestigational Tdap vaccine Formulation D
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
BIOLOGICALLicensed Tdap vaccine
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Modified double-blind: the study participant, the Investigator, and other study personnel remain unaware of the treatment assignments throughout the trial. An unblinded vaccine administrator will administer the appropriate vaccine but will not be involved in safety assessment and data collection.
Eligibility
Sex/Gender
ALL
Age
19 Years to 21 Years
Healthy volunteers
Yes
Inclusion criteria
: * Individuals born in Canada and vaccinated with a combination vaccine in accordance with the National Immunization Program (NIP). * Aged ≥ 19 years and \< 22 years on the day of inclusion. * Able to attend all scheduled visits and to comply with all trial procedures.
Exclusion criteria
* Pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 3 months after the last vaccination. To be considered of non-childbearing potential, a female must be pre-menarche, or post-menopausal for at least 1 year, or surgically sterile. * Participation at the time of study enrollment (or in the 4 weeks preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure. * Receipt of any vaccine in the 4 weeks preceding the first trial vaccination or planned receipt of any vaccine in the 4 weeks before and/or after any study vaccination except for influenza vaccination only, which may be received at least 2 weeks before or 2 weeks after any study vaccination. * History of autoimmune disorder. * History of cardiovascular disorder. * History of Guillain-Barré syndrome. * Receipt of immune globulins, blood or blood-derived products in the past 3 months. * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months). * Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances. * Laboratory-confirmed/self-reported thrombocytopenia, contraindicating intramuscular vaccination. * Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination. * Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion. * Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0 C). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided. * Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 unsolicited AEs | Within 30 days post-vaccination | AEs other than solicited reactions |
| 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 |
| 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 |
| Number of participants reporting Grade 2 and Grade 3 laboratory parameter abnormalities | Within 60 days post-vaccination | Haematological and biochemical laboratory parameters |
| 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) |
| GMCs of anti-diphtheria toxoid immunoglobulins | From Day 0 to Day 360 | Anti-diphtheria toxoid total immunoglobulins concentration will be measured by MSD ECL |
| GMCs of anti-tetanus toxoid immunoglobulins | From Day 0 to Day 360 | Anti-tetanus toxoid total immunoglobulins concentration will be measured by MSD ECL |
| Geometric means of antigen-specific cells | From Day 0 to Day 360 | Antigen specific cells will be measured by FLUOROSPOT |
| Percentages of antigen-specific cells | From Day 0 to Day 360 | Antigen specific cells will be measured by FLUOROSPOT |
Countries
Canada
Outcome results
None listed