Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Investigational Tdap vaccine Formulation B · 1 trial · 3 indications
AEs, including those related to the product administered
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
AEs other than solicited reactions
SAEs, including adverse event of special interest (AESIs)
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
AESIs are reported until the end of the safety follow-up period
Haematological and biochemical laboratory parameters
Anti-pertussis antigen immunoglobulins concentration will be measured by mesoscale discovery electrochemiluminescence (MSD ECL)
Anti-diphtheria toxoid total immunoglobulins concentration will be measured by MSD ECL
Anti-tetanus toxoid total immunoglobulins concentration will be measured by MSD ECL
Antigen specific cells will be measured by FLUOROSPOT
Antigen specific cells will be measured by FLUOROSPOT
| Arm | Type | Description |
|---|---|---|
| Group 1: Investigational Product (IP) Formulation A | EXPERIMENTAL | IP Formulation A administration, participation in Stage 1 and Stage 2 |
| Group 2: IP Formulation A | EXPERIMENTAL | IP Formulation A administration, participation in Stage 1 |
| Group 3: IP Formulation B | EXPERIMENTAL | IP Formulation B administration, participation in Stage 1 and Stage 2 |
| Group 4: IP Formulation B | EXPERIMENTAL | IP Formulation B administration, participation in Stage 1 |
| Group 5: IP Formulation C | EXPERIMENTAL | IP Formulation C administration, participation in Stage 1 and Stage 2 |
| Group 6: IP Formulation C | EXPERIMENTAL | IP Formulation C administration, participation in Stage 1 and Stage 2 |
| Group 7: IP Formulation D | EXPERIMENTAL | IP Formulation D administration, participation in Stage 1 and Stage 2 |
| Group 8: Tdap | ACTIVE_COMPARATOR | TdaP administration, participation in Stage 1 and Stage 2 |
| Group 9: Tdap | ACTIVE_COMPARATOR | TdaP administration, participation in Stage 1 |
| Name | Type | Description |
|---|---|---|
| Investigational Tdap vaccine Formulation B | BIOLOGICAL | Pharmaceutical form:Suspension for injection Route of administration: Intramuscular |
| Investigational Tdap vaccine Formulation C | BIOLOGICAL | Pharmaceutical form:Suspension for injection Route of administration: Intramuscular |
| Investigational Tdap vaccine Formulation A | BIOLOGICAL | Pharmaceutical form:Suspension for injection Route of administration: Intramuscular |
| Investigational Tdap vaccine Formulation D | BIOLOGICAL | Pharmaceutical form:Suspension for injection Route of administration: Intramuscular |
| Licensed Tdap vaccine | BIOLOGICAL | Pharmaceutical form:Suspension for injection Route of administration: Intramuscular |
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. Exclusio...
Investigational Tdap vaccine Formulation B is being studied for immunization against tetanus, diphtheria, and pertussis in healthy volunteers. It is an investigational vaccine candidate developed by Sanofi, currently in Phase 1 clinical development.
Investigational Tdap vaccine Formulation B is being developed by Sanofi, a biopharmaceutical company traded on the stock exchange under the ticker SNY. The company is conducting clinical trials to evaluate the vaccine's safety and immune response.
Investigational Tdap vaccine Formulation B is in Phase 1 clinical development. It is an investigational vaccine, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and immunogenicity.
Investigational Tdap vaccine Formulation B was studied in a Phase 1 clinical trial with the identifier NCT03958799. This completed trial enrolled 71 healthy young adults in Canada and compared the safety and immune response of four different formulations of the investigational Tdap vaccine against a licensed Tdap vaccine.
Investigational Tdap vaccine Formulation B is one of several formulations being tested by Sanofi in a clinical trial. It is compared against a licensed Tdap vaccine in the study, but it is not stated to be the same as any other named vaccine.