Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03958799 | 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 | PHASE1 | COMPLETED | 71 | — | — | Jun 26, 2019 | Apr 6, 2021 | Apr 25, 2022 | 5 | Canada |
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...