Trials / Unknown
UnknownNCT05933512
A Study to Evaluate the Immunogenicity and Safety of A Recombinant Protein COVID-19 Vaccine as Booster Vaccines
A Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01E-2 (COVID-19 Beta/Omicron (BA.1/BQ.1.1/XBB.1) Variants S-Trimer Vaccine) in Population Previously Vaccinated With mRNA COVID-19 Vaccine
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 600 (estimated)
- Sponsor
- Sinocelltech Ltd. · Industry
- Sex
- All
- Age
- 3 Years
- Healthy volunteers
- Accepted
Summary
This study is a phase Ⅱ clinical trial to evaluate the safety and immunogenicity of SCTV01E-2 in people of different ages who had been vaccinated with COVID-19 vaccines. A total of at least 600 subjects aged 3 years and older who were previously vaccinated with domestically licensed SARS-CoV-2 vaccines with recommended doses and immunization schedules are planned to be enrolled. Group A included 400 patients aged 18 years and above, and group B included 200 patients aged 3-17 years.
Detailed description
For participants in Group A, they will be randomized to receive SCTV01E or SCTV01E-2 in a ratio of 1:1. For participants in Group B, they will all receive SCTV01E-2.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | SCTV01E-2 | intramuscular injection |
| BIOLOGICAL | SCTV01E | intramuscular injection |
Timeline
- Start date
- 2023-08-10
- Primary completion
- 2023-12-10
- Completion
- 2024-11-10
- First posted
- 2023-07-06
- Last updated
- 2023-07-06
Source: ClinicalTrials.gov record NCT05933512. Inclusion in this directory is not an endorsement.