Trials / Completed
CompletedNCT02587520
Study of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed in Healthy Subjects
Safety and Immunogenicity of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (SP0173) in Healthy Adolescents, Adults, and Older Adults
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 1,363 (actual)
- Sponsor
- Sanofi Pasteur, a Sanofi Company · Industry
- Sex
- All
- Age
- 10 Years
- Healthy volunteers
- Accepted
Summary
This was a dose and formulation ranging study to assess the safety and immunogenicity of SP0173 in healthy adolescents, adults, and older adults in the United States (US). Primary Objective * To describe the safety profile of each SP0173 investigational formulation. Observational Objective: * To describe the immunogenicity of each SP0173 investigational formulation.
Detailed description
All participants received a single dose of vaccine, and were assessed for immunogenicity at baseline (pre-vaccination) and at 30 days post-vaccination. They were also monitored for safety from day of vaccination up to Day 180 post-vaccination.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed Formulation 1 | 0.5 milliliter (mL), Intramuscular |
| BIOLOGICAL | Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 2 | 0.5 mL, Intramuscular |
| BIOLOGICAL | Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 3 | 0.5 mL, Intramuscular |
| BIOLOGICAL | Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 4 | 0.5 mL, Intramuscular |
| BIOLOGICAL | Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed | 0.5 mL, Intramuscular |
| BIOLOGICAL | Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine | 0.5 mL, Intramuscular |
Timeline
- Start date
- 2015-10-22
- Primary completion
- 2017-02-21
- Completion
- 2017-02-21
- First posted
- 2015-10-27
- Last updated
- 2022-03-23
- Results posted
- 2020-03-04
Locations
20 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02587520. Inclusion in this directory is not an endorsement.