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Immunogenicity and Safety Study of Heterologous Booster Vaccination of a SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine(GBP510) Adjuvanted with AS03 in Adults Aged 18 Years and Older

NCT05501522 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 840

Last updated 2024-10-16

No results posted yet for this study

Summary

This is a Phase III, randomized, placebo-controlled, observer-blinded, parallel-group, multi-center study to assess the safety, reactogenicity, and immunogenicity of heterologous booster vaccination of SK SARS-CoV-2 recombinant protein nanoparticle vaccine (GBP510) adjuvanted with AS03 in adults aged 18 years and older.

Conditions

Interventions

BIOLOGICAL

GBP510 adjuvanted with AS03

injection volume of 0.5mL on Day 0

OTHER

Placebo (Normal Saline)

injection volume of 0.5mL on Day 0

Sponsors & Collaborators

  • Coalition for Epidemic Preparedness Innovations

    collaborator OTHER

  • International Vaccine Institute

    collaborator OTHER

  • GlaxoSmithKline

    collaborator INDUSTRY

  • SK Bioscience Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Santa K Das, MD · Institute of Medicine (IOM).

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-09
Primary Completion
2023-08-22
Completion
2024-08-17

Countries

  • Colombia
  • Nepal

Study Locations

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Entities

Diseases
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 NCT05501522 on ClinicalTrials.gov