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UNAIR Inactivated COVID-19 Vaccine Phase III (Immunobridging Study) | Clinical Trials | Clareo Health

UNKNOWNPHASE3

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

A Multicenter, Randomized, Double Blind, Controlled, Phase III Clinical Trial (Immunobridging Study) of Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) in Healthy Population Aged 18 Years and Above

NCT05508477•Dr. Soetomo General Hospital

View on ClinicalTrials.gov

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.

Detailed Description

This is a double blind randomized controlled trial - immunobridging study. There will be 2 groups in the study. One adult group (18 year-old and above) with 5 µg dose, and 1 control group using CoronaVac Bio Farma. Both vaccines will be administered with 2-dose schedule, intramuscularly. All cohorts will be followed for 6 months. This study will have two interim and one full analysis The main focus is immunogenicity and safety or reactogenicity issues. Data Safety Monitoring Board will be commissioned for this study to evaluate safety data over the study period and to review any events that meet a specific study pausing rule or any other safety issue that may arise. They will review the blinded 7 and 28 days safety data following the first dose of vaccine, and then the 7 and 28 days after the second dose. The immunogenicity data will be evaluated until 6 months after the second dose

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Healthy adults and elderly, males and females, 18 years of age and above. Healthy status will be determined by the investigator based on medical history, clinical laboratory results, vital sign measurements, and physical examination at screening.
•2. Subjects have been informed properly regarding the study and signed the informed consent form.
•3. Subject will commit to comply with the instructions of the investigator and the schedule of the trial
•4. Participants agree not to donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the last dose of study vaccine.
•5. Participants must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study.

Exclusion Criteria

•1. Subjects concomitantly enrolled or scheduled to be enrolled in another vaccine trial.
•2. Evolving mild, moderate, and severe illness, especially infectious diseases or fever (axillary temperature 37.5 degree Celcius or more) concurrent or within 7 days prior to first study vaccination. This includes respiratory or constitutional symptoms consistent with SARS-CoV-2 (cough, sore throat, difficulty in breathing, etc)
•3. Known history of allergy to any component of the vaccines.
•4. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
•5. Any autoimmune or immunodeficiency disease/condition
•6. Subjects who have received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulin, blood derived products, long term corticosteroid - more than 2 weeks, and so on), OR anticipation of the need for immunosuppressive treatment within 6 months after last vaccination. The use of topical or nasal steroid will be permitted.
•7. Unstable chronic disease, inclusive of uncontrolled hypertension, congestive heart failure, chronic obstructive pulmonary disease, asthma, chronic urticaria, diabetes requiring use of medicine. The final decision regarding this condition will be decided by the attending field clinicians or investigator.
•8. Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.
•9. Individuals who previously receive any vaccines against Covid-19.
•10. Subjects already immunized with any vaccine within 4 weeks prior and expect to receive other vaccines within 60 days following the first dose.
+15 more criteria

Locations (5)

Dr. Soebandi General Hospital

Jember, East Java, Indonesia

Jember Paru Hospital

Jember, East Java, Indonesia

Dr. Saiful Anwar General Hospital

Malang, East Java, Indonesia

Airlangga University Hospital

Surabaya, East Java, Indonesia

Dr. Soetomo General Hospital

Surabaya, East Java, Indonesia

Key Dates

Start Date

June 28, 2022

Primary Completion Date

March 28, 2023

Completion Date

May 28, 2023

Last Updated

August 29, 2022

Enrollment

4,005

ESTIMATED participants

Conditions

COVID-19 PandemicCOVID-19 Vaccines

Interventions

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

BIOLOGICAL

CoronaVac Biofarma COVID-19 Vaccine

BIOLOGICAL

Contacts

Dominicus Husada, MD

CONTACT

‭+6281232266377‬dominicushusada@yahoo.com

Damayanti Tinduh, MD

CONTACT

+6281703293335‬damayanti.tinduh@fk.unair.ac.id

Corona Virus Disease 2019 Cohort Study

NCT06927622

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 29, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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