Immunogenicity and Safety Study of SK SARS-CoV-2 Recombinant Nanoparticle Vaccine (GBP510) Adjuvanted With AS03 (COVID-19)

PHASE3CompletedINTERVENTIONAL
Enrollment

4,036

Participants

Timeline

Start Date

August 30, 2021

Primary Completion Date

October 2, 2023

Study Completion Date

October 2, 2023

Conditions
Covid19
Interventions
BIOLOGICAL

GBP510 adjuvanted with AS03 (Receptor-Binding Domain(RBD) 25ug/dose)

injection volume of 0.5mL on days 0 and 28 (stage1)

BIOLOGICAL

ChAdOx1-S not less than 2.5 × 10^8 infectious units

injection volume of 0.5mL on days 0 and 28 (stage1)

BIOLOGICAL

GBP510 adjuvanted with AS03 (Receptor-Binding Domain(RBD) 25ug/dose)

injection volume of 0.5mL on days 0 (stage2)

Trial Locations (38)

Unknown

Southern Clinicaltrials Waitemata, Auckland

Southern Clinical Trials Christchurch, Christchurch

Lakeland Clinicaltrials Waikato, Hamilton

Southern Clinical Trials Tasman, Nelson

Lakeland Clinicaltrials Culloden, Papamoa

Lakeland Clinicaltrials Rotorua, Rotorua

Lakeland Clinicaltrials Wellington, Upper Hutt

San Francisco Multi-Purpose Building, Manila

University of the East-Ramon Magsaysay Memorial Medical Center Inc., Manila

Health Index Multispeciality Clinic, Quezon City

Korea University Ansan Hostpital, Ansan

Ajou university hospital, Suwon

Dong-A University Hospital, Busan

Kyungpook National University Chilgok Hospital, Daegu

Kyungpook National University Hospital, Daegu

Chonnam National University Hospital, Gwangju

Gachon University Gil Medical Center, Incheon

Inha university hospital, Incheon

Ewha womans university medical center, Seoul

Hallym university medical center, Seoul

Korea university Anam hospital, Seoul

Korea University Guro Hospital, Seoul

Severance Hospital, Seoul

Wonju severance christian hospital, Wŏnju

Armed Forces Research Institute of Medical Sciences, Bangkok

Siriraj Hospital, Bangkok

Maharaj Nakorn Chiang Mai Hospital, Chiang Mai

Sriganarind Hospital, Khon Kaen

"Medical center Preventclinic LLC", Dniprodzerzhyns'k

Treatment and Diagnostic Center of LLC Treatment and Diagnostic Center Adonis Plus, Dnipro

Medical and Diagnostic Сеntег of Рrivatе Еntеrрrisе of Рrivatе Manufacturing Соmрапу Acinus, Kropyvnytskyi

Communal non-profit enterprise Kyiv City Clinical Hospital №6, Kyiv

"Medical Center Ok!Clinic+ of International Institute of Clinical Research LLC", Kyiv

"Municipal Nonprofit Enterprise Khmelnytsky Regional Hospital for War Veterans of Khmelnytsky Regional Council", Kyiv

Private Clinic LLC Blagomed, Odesa

Pasteur Institute, Hochiminh City

03080

Seoul national university hosptial, Seoul

04401

Soonchunhyang university hospital, Seoul

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

International Vaccine Institute

OTHER

collaborator

GlaxoSmithKline

INDUSTRY

collaborator

Coalition for Epidemic Preparedness Innovations

OTHER

lead

SK Bioscience Co., Ltd.

INDUSTRY

NCT05007951 - Immunogenicity and Safety Study of SK SARS-CoV-2 Recombinant Nanoparticle Vaccine (GBP510) Adjuvanted With AS03 (COVID-19) | Biotech Hunter | Biotech Hunter