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Efficacy, Safety and Immunogenicity Study of SARS-CoV-2 Inactivated Vaccine — COVID-19  

SARS-CoV2 Infection Clinical Trial

Official title:
A Phase III, Observer-blind, Randomized, Placebo-controlled Study of the Efficacy, Safety and Immunogenicity of SARS-CoV-2 Inactivated Vaccine in Healthy Adults Aged 18-59 Years in Indonesia

Clinical Trial Summary

This phase III trial aims to assess the efficacy, safety and immunogenicity of SARS-CoV-2 Vaccine (inactivated) and lot-to-lot consistency evaluation

Clinical Trial Description

This trial is Randomized, observer-blind, placebo-controlled two arms parallel group, prospective intervention study Approximately 1620 subjects aged 18-59 years will be enrolled in this trial for efficacy evaluation. Subjects will be divided into 2 treatment arms that are the vaccinated group and placebo group with ratio 1:1. The vaccinated arms will be grouped into three different lot number (lot 1/lot 2/ lot 3) of SARS-CoV-2 vaccine. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04508075
Study type Interventional
Source PT Bio Farma
Contact
Status Completed
Phase Phase 3
Start date August 10, 2020
Completion date August 31, 2021
View Details
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