MedTrace Logo

A Study on the Safety, Tolerability and Immune Response of SARS-CoV-2 Sclamp (COVID-19) Vaccine in Healthy Adults

NCT04495933 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2024-05-02

No results posted yet for this study

Summary

This study is being conducted to look at the safety and immune response (how the immune system of the human body reacts) to a vaccine for SARS-CoV-2 (the virus responsible for COVID-19 infection) when administered as an intramuscular injection (an injection directly into the muscle) to the upper arm of healthy participants, on two occasions at least 28 days apart.

Conditions

  • SARS-CoV2
  • Covid19

Interventions

BIOLOGICAL

MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 5mcg

MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 5mcg

BIOLOGICAL

MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 15mcg

MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 15mcg

BIOLOGICAL

MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 45mcg

MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 45mcg

OTHER

Placebo

sterile saline

Sponsors & Collaborators

  • Syneos Health

    collaborator OTHER

  • Coalition for Epidemic Preparedness Innovations

    collaborator OTHER

  • The University of Queensland

    lead OTHER

Principal Investigators

  • Paul Griffin, Dr · Nucleus Network Brisbane

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-13
Primary Completion
2024-04-30
Completion
2024-04-30

Countries

  • Australia

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 NCT04495933 on ClinicalTrials.gov