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Immunogenicity and Safety of AdCLD-CoV19-1 OMI As a Booster: a COVID-19 Preventive Vaccine in Healthy Volunteers | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE3

Immunogenicity and Safety of AdCLD-CoV19-1 OMI As a Booster: a COVID-19 Preventive Vaccine in Healthy Volunteers

A Phase III Multinational, Multicenter, Observer-Blinded, Randomized, Active-Controlled Trial to Evaluate the Immunogenicity and Safety of the Preventive COVID-19 Vaccine AdCLD-CoV19-1 OMI Administered As a Booster to Adults Aged 19 Years Old and Above

NCT05993325•Cellid Co., Ltd.

View on ClinicalTrials.gov

Summary

The immunogenicity and safety of AdCLD-CoV19-1 OMI (5.0x10\^10 VP (0.5 mL)/dose/Vial) administered as a booster in healthy adults aged 19 years old and above will be evaluated. Outcome assessment will be performed in comparison with Comirnaty Bivalent.

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Individual aged 19 and above and willing to provide written informed consent to participate study voluntarily.
•2. Individual fall under one or more of the following at the date of IP administration
•* At least past 16 weeks (112 days) without additional COVID-19 vaccination since the last COVID-19 vaccination.
•* At least past 16 weeks (112 days) since the release of quarantine due to COVID-19 confirmation.
•3. Individual who agrees to use medically acceptable contraceptive methods† for at least 4 weeks prior to screening and 12 weeks post IP administration.
•4. Individual who agrees not to donate or transfuse blood (including whole blood, plasma components, platelet components, platelet plasma components) throughout the study participation.

Exclusion Criteria

•1. Individual fall under one or more of the following at the date of IP administration
•* History of COVID-19 within 16 weeks (-111\~0 days) or considered to be infected prior to IP administration.
•* History of receiving COVID-19 vaccine within 16 weeks (-111\~0 days) prior to IP administration.
•2. Clinically significant abnormalities on clinical laboratory tests, electrocardiograms, and chest X-rays performed during screening visit.
•3. Positive HIV test result on the screening test.
•4. Acute febrile illness with (≥38°C), or any suspected infectious diseases, or COVID-19-like symptoms (cough, shortness of breath, chills, myalgia, headache, sore throat, loss of taste/smell, etc.) within 3 days prior to administration of IP.
•5. Any serious medical or psychiatric disease which in opinion of investigator judges unable to participate.
•* Respiratory diseases: Asthma, Chronic Obstructive Pulmonary Disease (COPD), active or latent tuberculosis which require medication, or individual who has received treatment due to worsening of the listed respiratory disease within 5 years prior to administration of IP.
•* Serious cardiovascular diseases: Congestive heart failure, coronary artery disease, myocardial infarction, uncontrolled hypertension, thrombocytopenia or venous thrombosis, capillary leakage syndrome, myocarditis, pericarditis, etc.
•* Neurologic diseases: Epilepsy, seizure within past 3 years, migraine, stroke, encephalopathy, Guillain-Barre Syndrome, encephalomyelitis, transverse myelitis, etc.
+26 more criteria

Locations (17)

The Medical City-Iloilo

Iloilo City, Philippines

West Visayas State University Medical Center

Iloilo City, Philippines

Tropical Disease Foundation, Inc.

Makati, Philippines

Far Eastern University - Nicanor Reyes Medical Foundation

Quezon City, Philippines

Dong-a University Hospital

Busan, South Korea

Kyungpook National University Hospital

Daegu, South Korea

Chungnam National University Hospital

Daejeon, South Korea

Chonnam National University Hospital

Gwangju, South Korea

Hallym University Dongtan Sacred Heart Hospital

Gyeonggi-do, South Korea

Korea University Ansan Hospital

Gyeonggi-do, South Korea

Key Dates

Start Date

November 27, 2023

Primary Completion Date

March 1, 2025

Completion Date

November 1, 2025

Last Updated

November 15, 2024

Enrollment

4,000

ESTIMATED participants

Conditions

COVID-19Vaccines

Interventions

AdCLD-CoV19-1 OMI

BIOLOGICAL

Comirnaty Bivalent 0.1mg/mL (tozinameran and riltozinameran)

BIOLOGICAL

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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: November 15, 2024Data 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.

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Immunogenicity and Safety of AdCLD-CoV19-1 OMI As a Booster: a COVID-19 Preventive Vaccine in Healthy Volunteers

Inclusion Criteria

Exclusion Criteria

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