Trials / Unknown
UnknownNCT05329051
A Study to Evaluate the Immunogenicity and Safety of a Recombinant Protein COVID-19 Vaccine in Population Aged ≥18 Years
A Randomized, Double-blind, Positive-controlled Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01E (A COVID-19 Alpha/Beta/Delta/Omicron Variants S-Trimer Vaccine) in Population Aged ≥18 Years and Previously Fully Vaccinated With mRNA COVID-19
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- Sponsor
- Sinocelltech Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The study is a randomized, double-blind, positive-controlled Phase II booster study. It will evaluate the immunogenicity and safety of SCTV01E compared with Comirnaty.
Detailed description
Approximately 400 participants aged ≥18 years old and previously vaccinated with 2 or 3 doses of Comirnaty will be enrolled in this study. They will be randomly assigned to SCTV01E Group and Comirnaty Group in a ratio of 1:1.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | SCTV01E | intramuscular injection |
| BIOLOGICAL | Comirnaty | intramuscular injection |
Timeline
- Start date
- 2022-07-01
- Primary completion
- 2022-09-01
- Completion
- 2023-03-01
- First posted
- 2022-04-14
- Last updated
- 2022-04-14
Source: ClinicalTrials.gov record NCT05329051. Inclusion in this directory is not an endorsement.