Trials / Completed
CompletedNCT04894305
A Study of Ad26.COV2.S in Healthy Adults (COVID-19)
A Phase 1, Randomized, Observer-blind Study to Compare the Safety, Reactogenicity, and Immunogenicity of Ad26.COV2.S at a Single Dose of 5*10^10 vp in 2 Different Volumes in Healthy Adults
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 380 (actual)
- Sponsor
- Janssen Vaccines & Prevention B.V. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to assess the safety and reactogenicity of Ad26.COV2.S (0.3 milliliter \[mL\] versus 0.5 mL) and to demonstrate non-inferiority (NI) of Ad26.COV2.S (0.3 mL versus 0.5 mL), 28 days after vaccination.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Ad26.COV2.S | Ad26.COV2.S will be administered as IM injection. |
Timeline
- Start date
- 2021-05-25
- Primary completion
- 2021-12-08
- Completion
- 2021-12-08
- First posted
- 2021-05-20
- Last updated
- 2021-12-22
Locations
1 site across 1 country: Netherlands
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04894305. Inclusion in this directory is not an endorsement.