Trials / Unknown
UnknownNCT05239806
A Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01C and SCTV01E in Population Aged ≥12 Years Previously Fully Vaccinated With Inactivated COVID-19 Vaccine
A Randomized, Double-blind Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01C (A Bivalent SARS-CoV-2 Trimeric Spike Protein Vaccine) and SCTV01E (A COVID-19 Alpha/Beta/Delta/Omicron Variants S-Trimer Vaccine) in Population Aged ≥12 Years Previously Fully Vaccinated With Inactivated COVID-19 Vaccine
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- Sponsor
- Sinocelltech Ltd. · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Accepted
Summary
The objective of study is to evaluate the immunogenicity and safety of SCTV01C or SCTV01E as booster compared with Sinopharm inactivated COVID-19 vaccine as booster. The study will also evaluate the immunogenicity and safety of 2-dose vaccinations.
Detailed description
The study is a randomized, double-blind, and approved vaccine-controlled Phase II booster study. It will evaluate the immunogenicity and safety of one dose of SCTV01C or SCTV01E as booster compared with one dose of Sinopharm inactivated COVID-19 vaccine or one dose of Commirnaty as booster. The study will also evaluate the immunogenicity and safety of 2-dose vaccinations (1-dose of SCTV01C and 1-dose of SCTV01E, or 2-dose of SCTV01E, or 1-dose of Sinopharm inactivated COVID-19 vaccine and 1-dose of SCTV01E, 1-dose of Comirnaty and 1-dose of SCTV01E).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | SCTV01C | Day 0; intramuscular injection |
| BIOLOGICAL | SCTV01E | Day 0; intramuscular injection |
| BIOLOGICAL | Sinopharm inactivated COVID-19 vaccine | Day 0; intramuscular injection |
| BIOLOGICAL | Comirnaty | Day 0; intramuscular injection |
| BIOLOGICAL | SCTV01E | Day 180; intramuscular injection |
Timeline
- Start date
- 2022-04-01
- Primary completion
- 2022-08-01
- Completion
- 2023-08-01
- First posted
- 2022-02-15
- Last updated
- 2022-04-11
Source: ClinicalTrials.gov record NCT05239806. Inclusion in this directory is not an endorsement.