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

NCT05007951 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4036

Last updated 2024-04-08

No results posted yet for this study

Summary

This is a 2-Stage, Phase III, randomized, active-controlled, observer-blind, parallel-group, multi-center study to compare the immunogenicity and safety of SK SARS-CoV-2 recombinant nanoparticle vaccine adjuvanted with AS03 (GBP510) to ChAdOx1-S in adults aged 18 years and older.

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)

Sponsors & Collaborators

  • International Vaccine Institute

    collaborator OTHER

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Coalition for Epidemic Preparedness Innovations

    collaborator OTHER

  • SK Bioscience Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Hee Jin Cheong · Korea University Guro Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-30
Primary Completion
2023-10-02
Completion
2023-10-02

Countries

  • New Zealand
  • Philippines
  • South Korea
  • Thailand
  • Ukraine
  • Vietnam

Study Locations

More Related Trials

Entities

Companies

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 NCT05007951 on ClinicalTrials.gov