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

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.

Timeline

Start

2020-12-15

Primary completion

2020-12-15

Completion

2022-04-09

Outcome

Outcome not reported

Stopped (Enrollment): “Seqirus discontinued V451\_07 Phase 2 start-up activities prior to enrolling subjects. Data from Phase 1 did not support further development. Further details are here: www.seqirus.com/news/update-on-the-university-of-queensland-covid-19-vaccine”

Drugs

Indications