An Efficacy, Immunogenicity and Safety Study Investigating an Adjuvanted SARS-CoV-2 Influenza Vac… (NCT04806529) | Clinical Trial Compass
WithdrawnPhase 2/3
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
Stopped: 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
0Started 2020-12-15
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Individuals 18 years of age or older on the day of informed consent.
✓. Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
✓. Individuals who can comply with study procedures including follow-up .
✓. Females of non-childbearing potential or females of childbearing potential who are using an effective birth control method which they intend to use for at least 30 days after the last study vaccination.
Exclusion criteria
✕. Females of childbearing potential3 who are pregnant, lactating, or who have not adhered to a specified set of contraceptive methods from at least 30 days prior to informed consent and who do not plan to do so until 2 months after the last vaccination.
✕. Progressive, unstable or uncontrolled clinical conditions such as decompensated congestive heart failure, cardiac arrhythmia, unstable angina, acute coronary syndrome or any major organ failure
✕. Hypersensitivity, including allergy, to any component of vaccine (including the adjuvant, MF59C.1), medicinal products or medical equipment whose use is foreseen in this study.
What they're measuring
1
Primary endpoint - preventing first occurrence of virologically-confirmed (RT-PCR) symptomatic COVID-19 cases as defined by ECDC guidance
Timeframe: 14 days post vaccination through until 12 months after the last vaccination.
2
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
Timeframe: 14 days post vaccination through until 12 months after the last vaccination.
✕. Abnormal function of the immune system resulting from:
✕. Clinical conditions.
✕. Systemic administration of corticosteroids (PO/IV/IM) at any dose for more than 14 consecutive days within 90 days prior to informed consent. Topical, inhaled and intranasal corticosteroids are permitted. Intermittent use (one dose in 30 days) of intra-articular corticosteroids are also permitted.