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UNAIR Inactivated COVID-19 Vaccine Phase III (Immunobridging Study)

NCT05508477 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4005

Last updated 2022-08-29

No results posted yet for this study

Summary

This study is a multicenter, randomized, double blind, controlled, phase III clinical trial (Immunobridging Study) to evaluate the immunogenicity and safety of Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) in healthy populations aged 18 years and above. Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) is an inactivated vaccine made of SARS-CoV-2 virus isolated from a patient in Surabaya, composed with aluminium hydroxy gel, tween 80, and L-histidine, and this study will be the first phase III in human.

Conditions

  • COVID-19 Pandemic
  • COVID-19 Vaccines

Interventions

BIOLOGICAL

Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) 5 µg

Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) contains purified S protein of SARS-CoV-2 - Dose: 5 µg, aluminium hydroxide gel, 10 mM L-Histidine buffer, 0.005%, Tween Polysorbate 80, and 0.9% Sodium chloride. Vaccine will be prepared in vial (1 ml per vial). One vial will be used for one injection only. The vial should be shaken well before injection.

BIOLOGICAL

CoronaVac Biofarma COVID-19 Vaccine

Control vaccine in this study is existing CoronaVac-BioFarma inactivated COVID-19 vaccine which has been used widely in Indonesia

Sponsors & Collaborators

  • Indonesia-MoH

    collaborator OTHER_GOV

  • Universitas Airlangga

    collaborator OTHER

  • Bioxis Pharmaceuticalls

    collaborator INDUSTRY

  • Dr. Soetomo General Hospital

    lead OTHER_GOV

Principal Investigators

  • Dominicus Husada, MD · Dr. Soetomo General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-28
Primary Completion
2023-03-28
Completion
2023-05-28

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 NCT05508477 on ClinicalTrials.gov