MedTrace Logo

Phase 3 Study to Evaluate the Lot Consistency of a Recombinant Coronavirus-Like Particle COVID-19 Vaccine

NCT05040789 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2023-06-02

No results posted yet for this study

Summary

This Phase 3 study is intended to assess clinical lot-to-lot consistency by evaluating and comparing the immunogenicity of three consecutively manufactured lots of Coronavirus-like Particle (CoVLP).

Conditions

Interventions

BIOLOGICAL

CoVLP formulation

The Coronavirus-Like Particle (CoVLP) COVID-19 Vaccine is composed of recombinant spike (S) glycoprotein expressed as virus-like particles (VLPs). The 3.75 µg dose of CoVLP will be administered with the adjuvant AS03 (manufactured by GlaxoSmithKline).

Sponsors & Collaborators

  • Medicago

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-22
Primary Completion
2022-05-31
Completion
2022-05-31
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT05040789 on ClinicalTrials.gov