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

Phase 2

Withdrawn

• Conditions: Influenza
• Interventions: Drug: Comparator; Drug: Adjuvanted SARS-CoV-2 Subunit vaccine (aCoV2)

• Registration Number: NCT04806529
• Lead Sponsor: Seqirus

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-15
• Primary Completion: 2020-12-15
• Status Verified: 2021-03
• Study First Submitted: 2021-03-17
• Study First Submitted QC: 2021-03-17
• Study First Posted: 2021-03-19
• Last Update Submitted: 2021-03-19
• Last Update Posted: 2021-03-23
• Study Completion: 2022-04-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The Comparator Group - Placebo	Comparator	The comparator group will receive a 2-dose series of 0.5 mL of the study vaccine, administered intramuscularly (IM) into the deltoid muscle, preferably in the non-dominant arm, Day 1 and Day 29 (e.g. 28 days apart)
Adjuvanted SARS-CoV-2 Subunit vaccine (aCoV2)	Adjuvanted SARS-CoV-2 Subunit vaccine (aCoV2)	The experimental group will receive a 2-dose series of 0.5 mL of the study vaccine, administered intramuscularly (IM) into the deltoid muscle, preferably in the non-dominant arm, Day 1 and Day 29 (e.g. 28 days apart)

Primary Outcome Measures

Name	Time	Method
Primary endpoint - preventing first occurrence of virologically-confirmed (RT-PCR) symptomatic COVID-19 cases as defined by ECDC guidance	14 days post vaccination through until 12 months after the last vaccination.
Co-primary endpoint - If successful, the co-primary measure of efficacy is preventing first-occurrence of symptomatic COVID-19 as defined by the US FDA guidance	14 days post vaccination through until 12 months after the last vaccination.

Secondary Outcome Measures

Name	Time	Method
Secondary endpoint #3- number of subjects admitted to ICU with RT-PCR-confirmed COVID-19 versus placebo	14 days post vaccination through until 12 months after the last vaccination
Secondary endpoint #2 - number of subjects hospitalized with RT-PCR-confirmed COVID-19 versus placebo	14 days post vaccination through until 12 months after the last vaccination
Secondary endpoint #1 - preventing first occurrence of RT-PCR confirmed severe COVID-19	14 days post vaccination through until 12 months after the last vaccination