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
NCT05239806 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 400
Last updated 2022-04-11
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.
Conditions
Interventions
- BIOLOGICAL
-
SCTV01C
Day 0; intramuscular injection
- BIOLOGICAL
-
SCTV01E
Day 0; intramuscular injection
- BIOLOGICAL
-
Sinopharm inactivated COVID-19 vaccine
Day 0; intramuscular injection
- BIOLOGICAL
-
Day 0; intramuscular injection
- BIOLOGICAL
-
SCTV01E
Day 180; intramuscular injection
Sponsors & Collaborators
-
Sinocelltech Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-04-01
- Primary Completion
- 2022-08-01
- Completion
- 2023-08-01
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