InfluenzaPhase 2/3NCT04806529
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
A Phase 2/3 study testing Adjuvanted SARS-CoV-2 Subunit vaccine (aCoV2) and Comparator in people with Influenza, run by Seqirus.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Adjuvanted SARS-CoV-2 Subunit vaccine (aCoV2) and Comparator
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2020to 9 Apr 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
- History of Guillain-Barré Syndrome or acute disseminated encephalomyelitis (ADEM)
- Abnormal function of the immune system resulting from:
Show all 17Show fewer
- 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.
- Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.
- Received immunoglobulins or any blood products within 90 days prior to informed consent
- Received an investigational or non-registered medicinal product within 30 days prior to informed consent or an investigational coronavirus vaccine (SARS-CoV; MERS-CoV) at any time prior to informed consent
- Individuals who received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this study or who are planning to receive any vaccine within 28 days from the study vaccines.
- Acute (severe) febrile illness (see Section 4.3)
- Known positive serology for human immunodeficiency virus (HIV) type 1 or 2 antibodies, hepatitis B virus surface antigen, or hepatitis C virus antibody
- Acute COVID-19 infection (positive COVID-19 test: nasopharyngeal swab) at screening, or Day 1
- Study personnel or immediate family or household member of study personnel
- Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study
About this study
Official title: A Phase 2/3 Randomised, Observer-blind, Placebo-controlled, Multi-centre Study to Evaluate the Efficacy, Immunogenicity and Safety of the Adjuvanted SARS-CoV-2 Subunit Vaccine in Adults Aged 18 Years and Above
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
- Influenza
- Being tested
- Adjuvanted SARS-CoV-2 Subunit vaccine (aCoV2), Comparator
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjuvanted SARS-CoV-2 Subunit vaccine (aCoV2)Drug
Also called Tthe aCoV2 group
Biological/Vaccine: Investigational adjuvanted SARS-CoV-2 Subunit vaccine
ComparatorDrug
Also called The Placebo Group
Biological/Vaccine: A dose of 0.5 mL saline for injection will be administrated to subjects randomized to receive the placebo
| Study group | Role | What they receive |
|---|---|---|
| Adjuvanted SARS-CoV-2 Subunit vaccine (aCoV2) | Experimental | 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) Receives: Drug: Adjuvanted SARS-CoV-2 Subunit vaccine (aCoV2) |
| The Comparator Group - Placebo | 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) Receives: Drug: Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint - preventing first occurrence of virologically-confirmed (RT-PCR) symptomatic COVID-19 cases as defined by ECDC guidance
Measured: 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
Measured: 14 days post vaccination through until 12 months after the last vaccination.
Secondary outcomes (3)
Secondary endpoint #1 - preventing first occurrence of RT-PCR confirmed severe COVID-19
Measured: 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
Measured: 14 days post vaccination through until 12 months after the last vaccination
Secondary endpoint #3- number of subjects admitted to ICU with RT-PCR-confirmed COVID-19 versus placebo
Measured: 14 days post vaccination through until 12 months after the last vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start15 Dec 2020 (estimated)
- Primary completion15 Dec 2020 (estimated)
- Study completion9 Apr 2022 (estimated)
Why it 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
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Observer-blind design, 2-arm, parallel group with 1:1 randomization between aCoV2 and placebo, equally stratified by age in two age subgroups, 18-55 years and 56 years and older
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seqirus
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04806529
- Sponsor's protocol ID
- V451_07
- Status last verified
- Mar 2021
- First submitted
- 17 Mar 2021
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: SEQIRUS supports the release of anonymized subject-level and study-level data in compliance with regulatory requirements, including Clinical Documents which are part of the CTD modules submitted to regulatory agencies for public release. Summary results disclosure is either in document form (e.g., ICH E3 Clinical Study Report synopsis) or structured data form (such as summary results in ClinicalTrials.gov (United States) or eudract.ema.europa.eu (EU Clinical Trial Registry \[EU CTR\]) Supporting Information: * Study Protocol * Statistical Analysis Plan (SAP)
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2/3 Randomised, Observer-blind, Placebo-controlled, Multi-centre Study to Evaluate the Efficacy, Immunogenicity and Safety of the Adjuvanted SARS-CoV-2 Subunit Vaccine in Adults Aged 18 Years and Above
- ClinicalTrials.gov ID
- NCT04806529
- Acronym / sponsor ID
- V451_07
- Conditions
- Influenza
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason 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
- Enrolment
- 0 participants (actual)
- Lead sponsor
- SeqirusIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2020 (estimated)
- Primary completion
- 15 Dec 2020 (estimated)
- Study completion
- 9 Apr 2022 (estimated)
- First posted
- 19 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Observer-blind design, 2-arm, parallel group with 1:1 randomization between aCoV2 and placebo, equally stratified by age in two age subgroups, 18-55 years and 56 years and older
| Arm | Type | Receives |
|---|---|---|
| Adjuvanted SARS-CoV-2 Subunit vaccine (aCoV2) | Experimental | Drug: 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) |
| The Comparator Group - Placebo | Placebo comparator | Drug: ComparatorThe 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
- Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
- History of Guillain-Barré Syndrome or acute disseminated encephalomyelitis (ADEM)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adjuvanted SARS-CoV-2 Subunit vaccine (aCoV2)Also: Tthe aCoV2 groupBiological/Vaccine: Investigational adjuvanted SARS-CoV-2 Subunit vaccine | Drug | Adjuvanted SARS-CoV-2 Subunit vaccine (aCoV2) |
| ComparatorAlso: The Placebo GroupBiological/Vaccine: A dose of 0.5 mL saline for injection will be administrated to subjects randomized to receive the placebo | Drug | The Comparator Group - Placebo |
Primary outcome
Primary endpoint - preventing first occurrence of virologically-confirmed (RT-PCR) symptomatic COVID-19 cases as defined by ECDC guidance
Time frame: 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
Time frame: 14 days post vaccination through until 12 months after the last vaccination.
3 secondary outcomes
Secondary endpoint #1 - preventing first occurrence of RT-PCR confirmed severe COVID-19
Time frame: 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
Time frame: 14 days post vaccination through until 12 months after the last vaccination
Secondary endpoint #3- number of subjects admitted to ICU with RT-PCR-confirmed COVID-19 versus placebo
Time frame: 14 days post vaccination through until 12 months after the last vaccination
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Individual participant dataSharing planned: Yes. SEQIRUS supports the release of anonymized subject-level and study-level data in compliance with regulatory requirements, including Clinical Documents which are part of the CTD modules submitted to regulatory agencies for public release. Summary results disclosure is either in document form (e.g., ICH E3 Clinical Study Report synopsis) or structured data form (such as summary results in ClinicalTrials.gov (United States) or eudract.ema.europa.eu (EU Clinical Trial Registry [EU CTR]) Supporting Information: * Study Protocol * Statistical Analysis Plan (SAP)
Related trials for Influenza
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Adjuvanted SARS-CoV-2 Subunit vaccine (aCoV2) and Comparator in people with Influenza, run by Seqirus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint - preventing first occurrence of virologically-confirmed (RT-PCR) symptomatic COVID-19 cases as defined by ECDC guidance (time frame: 14 days post vaccination through until 12 months after the last vaccination.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2021.