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Safety and Immunogenicity Study of COVID-19 Protein Subunit Recombinant Vaccine

NCT05313035 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2023-04-13

No results posted yet for this study

Summary

This trial is observer-blind, comparative, randomized, placebo-controlled phase 2 study. The population is healthy subjects aged 18 and above

Conditions

Interventions

BIOLOGICAL

SARS-CoV-2 protein subunit recombinant vaccine

candidate vaccine manufactured by PT. Bio Farma

BIOLOGICAL

placebo

the placebo is NaCl injection manufactured by PT. Bio Farma

Sponsors & Collaborators

  • Faculty of Medicine, Universitas Indonesia, Jakarta

    collaborator UNKNOWN

  • Faculty of Medicine, Diponegoro University, Semarang

    collaborator UNKNOWN

  • Faculty of Medicine, Universitas Andalas, Padang

    collaborator UNKNOWN

  • Faculty of Medicine, Universitas Hassanudin, Makassar

    collaborator UNKNOWN

  • PT Bio Farma

    lead INDUSTRY

Principal Investigators

  • Prof. Dr. Soedjatmiko SpA(K), MSi, 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
2022-04-13
Primary Completion
2022-07-22
Completion
2023-02-28

Countries

  • Indonesia

Study Locations

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Entities

Drugs
Diseases

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 NCT05313035 on ClinicalTrials.gov