A Study to Evaluate the Immunogenicity and Safety of a Recombinant Protein COVID-19 Vaccine SCTV01E-1 in Population Aged Above 18 Years
NCT05522829 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 400
Last updated 2022-08-31
Summary
The study is a randomized, double-blind Phase II study. It will evaluate the immunogenicity and safety of SCTV01E-1. Approximately 400 participants aged 18 years and older will be enrolled in this study. 160 participants who have not been vaccinated with any COVID-19 vaccine will be enrolled in Cohort 1 and randomly assigned to receive SCTV01E-1 or SCTV01E in a ratio of 1:1. 240 participants who were fully vaccinated with 2 or 3 doses of inactivated COVID-19 vaccines at least three months ago will be enrolled in Cohort 2 and randomly assigned to receive SCTV01E-1 or SCTV01E in a ratio of 1:1.
Conditions
Interventions
- BIOLOGICAL
-
SCTV01E-1 on D0
Day 0; intramuscular injection
- BIOLOGICAL
-
SCTV01E-1 on D28
Day 28; intramuscular injection
- BIOLOGICAL
-
SCTV01E-1 on D150
Day 150; intramuscular injection
- BIOLOGICAL
-
SCTV01E on D0
Day 0; intramuscular injection
- BIOLOGICAL
-
SCTV01E on D28
Day 28; intramuscular injection
- BIOLOGICAL
-
SCTV01E on D150
Day 150; intramuscular injection
- BIOLOGICAL
-
SCTV01E-1 on D120
Day 120; intramuscular injection
- BIOLOGICAL
-
SCTV01E on D120
Day 120; intramuscular injection
Sponsors & Collaborators
-
Sinocelltech Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-10-15
- Primary Completion
- 2022-12-15
- Completion
- 2023-12-15
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