Study Information for Participants: Investigating a potential new vaccine for COVID-19 and flu
Quick Reference:
What is the purpose of this study?
Where is my nearest study site?
What is the purpose of this study?
The primary goal of this clinical trial is to evaluate the safety and ability of an investigational combination vaccine to generate protective antibodies against both COVID-19 and seasonal flu viruses in adults age 65 and over. Researchers will assess if this dual vaccine can help prevent infection from these viruses or reduce the risk of severe illness if infected. Additionally, the study will compare the experimental vaccine's efficacy to another vaccine to determine if it offers enhanced immunity and protection.
Where is my nearest study site?
We are currently recruiting for this study in the following locations:
Australia:
WA, NT, SA, VIC, NSW and QLD.
New Zealand:
Auckland, Wellington, Hawke's bay, Dunedin, Palmerston North, Tauranga, Lower Hutt and Paraparaumu
Please click on the map below to see your nearest site.
What is Covid-19 & Influenza?
COVID-19 and influenza (the flu) are viral respiratory diseases that can cause coughing, fatigue, and breathing issues. COVID-19 stems from a coronavirus, while flu viruses cause influenza. Both illnesses may lead to severe complications like pneumonia in older adults and those with underlying conditions, potentially resulting in hospitalisation or death.
Who can participate?
To take part in this study, you will need to meet all the following:
- Aged 65 years or older.
- In general good health.
- Have received your primary vaccination series against COVID-19 with or without a booster.
Who cannot participate?
Unfortunately, if any of the following apply to you, this study is not the right fit for you:
- History of myocarditis or pericarditis.
- 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 (there will be discussed during phone screening).
Additional eligibility requirements apply. If you’re still unsure about your suitability, please feel free to register your interest, and our Patient Experience team will contact you for a personalised discussion.
What is involved?
If you are deemed eligible for the study, your participation is expected to last approximately 26 weeks. This includes:
- A three-hour screening visit at the study site to assess your eligibility. If you are deemed eligible, you will be randomly assigned to receive the study vaccine or the control (another flu vaccine).
- Up to three follow-up visits to the study site, during which you will undergo health checks and discuss any questions for one to two hours.
- Up to four phone calls, during which the study team will ask you a few questions.
Participation in this research is voluntary, and you may withdraw from the study at any time.
If you take part in the research study, there will be:
- Reimbursement of costs: For reasonable out-of-pocket expenses, such as travel and parking.
- Convenience: There are no overnight stays.
- Contribution to medical research: Help investigate a potential new vaccine that could provide improved protection against COVID-19 and flu.
Why is this study important?
Existing COVID-19 and flu vaccines require separate injections, while a combination vaccine could protect against both viruses with a single shot. This approach may improve vaccination compliance and immune response compared to individual vaccines. This study is vital to advancing more efficient vaccination strategies and determining if a combination vaccine is safe, generates sufficient antibodies, and offers enhanced prevention of infection or severe disease versus other vaccines for COVID-19 and Influenza.
Who is involved?
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.
Your participation in this research study has the potential to advance our understanding of medical science, lead to improved treatments, and deliver better health outcomes.
FOR MORE INFORMATION AND TO REGISTER YOUR INTEREST, VISIT US AT COVIDFLUSTUDY.COM
This trial has been approved by an independent ethics committee.
Ready to register? Click here to sign up/login to Evrilink and start your clinical trial journey.
Still have questions? Use the form below and one of our patient experience team members will be in touch to assist with your enquiry!