Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru
NCT04612972 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 12000
Last updated 2023-05-01
Summary
This is a multicenter, randomized, double blind, parallel placebo controlled, phase 3 clinical trial to evaluate the protective efficacy, safety and immunogenicity of inactivated SARS-CoV-2 vaccines in healthy population 18 years old and above.
Conditions
Interventions
- BIOLOGICAL
-
Inactivated SARS CoV 2 vaccine (Vero cell) Wuhan/Beijing/Placebo
This clinical trial is conducted in randomized, blind, placebo controlled design Total sample size is 12 000, which are randomly allocated into investigational vaccine 1, investigational vaccine 2 and placebo control group.
Sponsors & Collaborators
-
National University of San Marcos, Peru
collaborator OTHER -
Universidad Peruana Cayetano Heredia
lead OTHER
Principal Investigators
-
Coralith Garcia, MD · Universidad Peruana Cayetano Heredia
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-09-09
- Primary Completion
- 2021-02-19
- Completion
- 2023-04-03
Countries
- Peru
Study Locations
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