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An Efficacy, Immunogenicity and Safety Study Investigating an Adjuvanted SARS-CoV-2 Influenza Vaccine to Protect Against COVID-19 in Adults Over Aged 18 Years-old and Older

NCT04806529 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2021-03-23

No results posted yet for this study

Summary

The primary efficacy objective is to demonstrate the efficacy of aCoV2 versus a placebo to prevent the first occurrence of virologically-confirmed symptomatic COVID 19 according to the European Centre for Disease Prevention and Control (ECDC) COVID 19 case definition. The co-primary efficacy objective is to demonstrate the efficacy of aCoV2 versus a placebo to prevent virologically confirmed symptomatic COVID 19 defined by the US Food and Drug Administration (FDA) guidance.

Conditions

Interventions

DRUG

Adjuvanted SARS-CoV-2 Subunit vaccine (aCoV2)

Biological/Vaccine: Investigational adjuvanted SARS-CoV-2 Subunit vaccine

DRUG

Comparator

Biological/Vaccine: A dose of 0.5 mL saline for injection will be administrated to subjects randomized to receive the placebo

Sponsors & Collaborators

  • Seqirus

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-15
Primary Completion
2020-12-15
Completion
2022-04-09
FDA Drug
Yes

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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 NCT04806529 on ClinicalTrials.gov