NCT04508075

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,620 (actual)
• Sponsor: PT Bio Farma · Industry
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

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

Detailed 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.

Conditions

• SARS-CoV2 Infection

Interventions

Type	Name	Description
BIOLOGICAL	SARS-CoV-2 vaccine (inactivated)	SARS-CoV-2 vaccine (inactivated) manufactured by Sinovac
BIOLOGICAL	Placebo	Placebo manufactured by PT. Bio Farma

Timeline

• Start date: 2020-08-10
• Primary completion: 2021-01-09
• Completion: 2021-08-31
• First posted: 2020-08-11
• Last updated: 2022-01-13

Locations

1 site across 1 country: Indonesia