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 an experimental vaccine developed by Sanofi for tetanus immunization. It is one of four formulations studied against a licensed Tdap vaccine. The vaccine is designed to protect against tetanus, and the study also evaluated immune responses for diphtheria and pertussis. It remains in clinical development and is not approved.
Investigational Tdap vaccine Formulation B is being studied for tetanus immunization in healthy adults. The Phase 1 trial also assessed immune responses for diphtheria and pertussis immunizations. It is intended as a booster or primary vaccination against these bacterial infections, but it is not yet approved for use.
Sanofi, which trades under the ticker SNY, is developing Investigational Tdap vaccine Formulation B. Sanofi is a global pharmaceutical company, and this vaccine candidate is part of its vaccine research pipeline. The company sponsored the Phase 1 trial that evaluated this formulation.
Investigational Tdap vaccine Formulation B is in Phase 1 clinical development. A single Phase 1 trial has been completed. The vaccine is not FDA approved and remains investigational. No active trials are currently listed for this specific formulation.
Investigational Tdap vaccine Formulation B was evaluated in a completed Phase 1 trial, NCT03958799. The study enrolled 71 healthy adults aged 19 years and older in Canada. It was randomized, double-blind, and active-controlled, comparing four formulations of an investigational Tdap vaccine to a licensed Tdap vaccine.