drugset / Trial / 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
RandomizedParallel-groupQuadruple-blindPrevention
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
Timeline
- Start
- 2019-06-26
- Primary completion
- 2021-04-06
- Completion
- 2021-04-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Investigational Tdap vaccine Formulation A | Vaccine | — | Intramuscular |
| Subject | Investigational Tdap vaccine Formulation B | Vaccine | — | Intramuscular |
| Subject | Investigational Tdap vaccine Formulation C | Vaccine | — | Intramuscular |
| Subject | Investigational Tdap vaccine Formulation D | Vaccine | — | Intramuscular |
| Comparator | Licensed Tdap vaccine | Vaccine | — | Intramuscular |
Indications
No indication recorded.