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ACTIVE NOT RECRUITING
NCT05993325
PHASE3

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

Sponsor: 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.

Official title: 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

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

4000

Start Date

2023-11-27

Completion Date

2025-11

Last Updated

2024-11-15

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

AdCLD-CoV19-1 OMI

3000 participants will receive investigational product (AdCLD-CoV19-1 OMI) via intramuscular administration in the deltoid muscle

BIOLOGICAL

Comirnaty Bivalent 0.1mg/mL (tozinameran and riltozinameran)

1000 participants will receive investigational product (Comirnaty Bivalent) via intramuscular administration in the deltoid muscle

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

The Catholic University of Korea, ST. Vincent's Hospital

Gyeonggi-do, South Korea

Gachon University Gil Medical Center

Incheon, South Korea

Inha University Hospital

Incheon, South Korea

Hallym University Kangnam Sacred Heart Hospital

Seoul, South Korea

Korea University Guro Hospital

Seoul, South Korea

The Catholic University of Korea, Eunpyeong St. Mary's Hospital

Seoul, South Korea

Veterans Health Service Medical Center

Seoul, South Korea