The Covid & Flu Vaccine Study
This study aims to evaluate the safety and effectiveness of a potential new combination vaccine for COVID-19 and seasonal flu. Up to 9,320 people will participate in this important research across Australia and New Zealand. COVID-19 is caused by a coronavirus and flu by influenza viruses - both can lead to severe respiratory illness, hospitalisations, and deaths, especially among older adults.
Are you at least 65 years old, in general good health, and interested in advancing vaccine research? If so, keep reading to see if you may be eligible for this vital clinical trial, and how to get involved.
Eligibility:
- Aged 65 years and older
- In general good health
- Have received your primary vaccination series against COVID-19 with or without a booster
Duration:
- Up to four clinic visits (includes one visit during which you will receive the study vaccine)
- Up to six phone calls, during which the study team will ask you a few questions
- Approximately 52 weeks (364 days)
Study Locations:
Australia: ACT, NSW, VIC, QLD, WA, SA, NT
New Zealand: Auckland, Aotearoa, Wellington, Hawke's Bay, Christchurch, Rotorua, Tauranga, Lower Hutt and Paraparaumu
If you take part in the research study, there will be:
Get paid for your participation
Eligible participants who complete the trial will be reimbursed for their time and reasonable out-of-pocket expenses.
Convenience
Multiple clinic locations and there are no overnight stays.
Contribution to medical research
Help investigate a potential new vaccine that hopes to provide improved protection against COVID-19 and flu.
About this study:
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Who can take part in this study?
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To take part in this study, you will need to meet all the following (other criteria apply):
- Aged 65 years or older
- BMI of 17 to 40 kg/m2
- In general good health
- Have received your primary vaccination series against COVID-19 with or without a booster
02
Who is unable to take part in this study?
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Unfortunately, if any of the following apply to you, this study is not the right fit for you:
- History of myocarditis, pericarditis, or motor neuropathy.
- Unstable acute or chronic conditions that have required hospitalisation, a change in medication, and/or other major treatment changes in the past two to six months (these will be discussed during phone screening).
Please note, additional eligibility criteria apply. If you’re still unsure if this trial is suitable to your needs, please do not hesitate to register your interest. Our dedicated Patient Experience team will contact you for a personalised discussion about your eligibility.
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How long will this study take?
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If you are deemed eligible for the study, and you agree to take part, your participation is expected to last approximately 52 weeks. This will include:
- A screening visit (Day 1): During the screening visit, which is expected to take up to three hours, you will attend the study site to undergo eligibility assessments. Upon confirmation of your eligibility, you will then be randomly assigned to a study group and administered the study vaccine or a control* on the same day.
- Up to three follow-up visits: During the follow-up visits, which are expected to last between one to two hours, you’ll undergo health checks so the research team can track you are feeling and to answer any questions you may have.
- Up to six follow-up phone calls.
- Completion of electronic diary - you will be asked to download an app on your smartphone or device and enter notes about your symptoms every day for one week following your vaccination with the study vaccine.
* For this clinical trial, there will be a control group that receives another licensed flu vaccine. Having a control group is crucial because it allows researchers to compare results and determine if the new combination vaccine is more effective than current options.
Participation in this research is voluntary, and you may withdraw from the study at any time.
04
What is the purpose of this study?
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The purpose of this study is to investigate if a new combination vaccine is safe and effective at producing antibodies to protect adults aged 65 years and over against COVID-19 and flu viruses, and/or prevent serious illness if infection does occur. It will also compare the new vaccine's performance to another authorised or licensed vaccine to ensure it provides improved protection.
05
What are Covid-19 and flu?
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COVID-19 and flu are contagious respiratory illnesses caused by different viruses. COVID-19 is caused by a coronavirus, while flu is caused by influenza viruses. Both can lead to persistent coughing, fatigue, and difficulty breathing. In some cases, they can cause severe complications like pneumonia, cardiac issues, and sepsis, especially in older adults and those with pre-existing medical conditions. These viral infections can result in hospitalisations and deaths, thus making prevention through vaccination crucial.
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Why is this study important?
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Current COVID-19 and flu vaccines are administered as individual shots. Combination vaccines, meanwhile, merge two or more individual vaccines into a single shot. Combination vaccines may be more beneficial compared to single vaccines, as they allow people to be vaccinated against several diseases with just one injection, thereby making it easier to stick to vaccination schedules. As such, this study is important to evaluate if a dual COVID-19/flu vaccine can provide improved protection compared to current vaccine approaches.
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Who is sponsoring this study?
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This study is being sponsored by Novavax, a global company advancing protein-based vaccines with its Matrix-M™ adjuvant. Novavax promotes improved health by discovering, developing and commercializing innovative vaccines to help protect against serious infectious diseases.
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What if I have other questions about the study?
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You can read more information about this study at the Australian New Zealand Clinical Trial Registry (ANZCTR) through this link.
Or - Click or tap this button to send an email to our Patient Experience team:
Ready to register? Help make medical breakthroughs happen.
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