Trials / Completed
CompletedNCT03958799
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
Safety and Immunogenicity of an Investigational Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Adsorbed (Tdap) Vaccine in Young Adults
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 71 (actual)
- Sponsor
- Sanofi Pasteur, a Sanofi Company · Industry
- Sex
- All
- Age
- 19 Years – 21 Years
- Healthy volunteers
- Accepted
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
Conditions
- Tetanus Immunisation (Healthy Volunteers)
- Diphtheria Immunisation (Healthy Volunteers)
- Pertussis Immunisation (Healthy Volunteers)
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Investigational Tdap vaccine Formulation B | Pharmaceutical form:Suspension for injection Route of administration: Intramuscular |
| BIOLOGICAL | Investigational Tdap vaccine Formulation C | Pharmaceutical form:Suspension for injection Route of administration: Intramuscular |
| BIOLOGICAL | Investigational Tdap vaccine Formulation A | Pharmaceutical form:Suspension for injection Route of administration: Intramuscular |
| BIOLOGICAL | Investigational Tdap vaccine Formulation D | Pharmaceutical form:Suspension for injection Route of administration: Intramuscular |
| BIOLOGICAL | Licensed Tdap vaccine | Pharmaceutical form:Suspension for injection Route of administration: Intramuscular |
Timeline
- Start date
- 2019-06-26
- Primary completion
- 2021-04-06
- Completion
- 2021-04-06
- First posted
- 2019-05-22
- Last updated
- 2022-04-25
Locations
5 sites across 1 country: Canada
Source: ClinicalTrials.gov record NCT03958799. Inclusion in this directory is not an endorsement.