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Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine

NCT05067894 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2022-08-09

No results posted yet for this study

Summary

The study is an observer-blind, randomized, controlled prospective intervention study of Phase I. The primary objective is To evaluate the safety of the SARS-CoV-2 protein subunit recombinant vaccine within 7 days after each dose.

Conditions

  • Covid19

Interventions

BIOLOGICAL

SARS-CoV-2 Protein Subunit Recombinant Vaccine

intramuscular injection

BIOLOGICAL

SARS-CoV-2 Inactivated Vaccine

intramuscular injection

Sponsors & Collaborators

  • Fakultas Kedokteran Universitas Indonesia

    collaborator OTHER

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

    collaborator OTHER

  • PT Bio Farma

    lead INDUSTRY

Principal Investigators

  • Prof. Rini Sekartini, MD · Fakultas Kedokteran Universitas Indonesia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-10
Primary Completion
2022-04-11
Completion
2022-08-06

Countries

  • Indonesia

Study Locations

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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 NCT05067894 on ClinicalTrials.gov