A Study to Evaluate the Immunogenicity and Safety of Two Recombinant Protein COVID-19 Vaccines in Population Aged ≥18 Years as Booster Vaccines
NCT05323461 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1800
Last updated 2023-04-10
Summary
The study is a randomized, double-blind, and positive-controlled Phase III booster study. It will evaluate the immunogenicity and safety of one dose of SCTV01C or SCTV01E as booster compared with either one dose of Sinopharm inactivated COVID-19 vaccine (Cohort 1) or one dose of Comirnaty (Cohort 2).
Conditions
Interventions
- BIOLOGICAL
-
SCTV01C
intramuscular injection
- BIOLOGICAL
-
SCTV01E
intramuscular injection
- BIOLOGICAL
-
Sinopharm inactivated COVID-19 vaccine
intramuscular injection
- BIOLOGICAL
-
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
- 2022-05-30
- Primary Completion
- 2022-10-28
- Completion
- 2023-05-01
Countries
- United Arab Emirates
Study Locations
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