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

NCT04508075 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1620

Last updated 2022-01-13

No results posted yet for this study

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

Conditions

  • SARS-CoV2 Infection

Interventions

BIOLOGICAL

SARS-CoV-2 vaccine (inactivated)

SARS-CoV-2 vaccine (inactivated) manufactured by Sinovac

BIOLOGICAL

Placebo

Placebo manufactured by PT. Bio Farma

Sponsors & Collaborators

  • Faculty of Medicine Universitas Padjadjaran

    collaborator UNKNOWN

  • National Intitute of Health Research and Development, Ministry of Health Republic of Indonesia

    collaborator UNKNOWN

  • Sinovac Life Sciences Co., Ltd.

    collaborator INDUSTRY

  • PT Bio Farma

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-10
Primary Completion
2021-01-09
Completion
2021-08-31

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04508075 on ClinicalTrials.gov