Status:
Enrolling
Condition or Disease:
Seasonal Influenza
Medication:
mRNA-1010
Founded in 1998500+ safe and successful trialsExemplary safety recordCutting-edge technologyPhase I specialist
Seasonal Influenza Vaccine
Summary
Seasonal Influenza - A Recurrent Public Health Threat
Seasonal influenza, commonly known as the flu, is a significant public health concern, particularly for adults aged 50 and older. This age group is more susceptible to severe illness and complications from the flu, leading to substantial societal and healthcare burdens. In light of the recent Covid-19 Pandemic and it’s far reaching impact on society, Seasonal Flu may seem like a trivial matter but Influenza still poses a serious threat to all age groups.
The broader impact that seasonal Influenza has on society and the healthcare system underscores the importance of preventive measures, including vaccination, early treatment, and public health campaigns. By prioritizing influenza prevention and management, we can reduce the economic burden, maintain workforce productivity, and ensure the healthcare system can effectively serve all patients. mRNA Vaccinations such as mRNA-1010 could become an effective tool to combat seasonal respiratory viruses. mRNA vaccinations represent a novel approach with potential advantages over traditional vaccines such as:
- Faster Development and Production
- Greater Flexibility and Adaptability
- Enhanced Immune Response
- Elimination of Egg-Based Production Issues
- Scalability and Distribution
What is the Purpose of this trial?
mRNA-1010 is an investigational vaccine being studied in this clinical trial to prevent seasonal flu. This trial will compare mRNA-1010 to Fluarix®/Influsplit®, which is a US Food and Drug Administration (FDA)/ the European Medicines Agency (EMA) approved vaccine currently used to prevent seasonal flu infection. Fluarix® and Influsplit® are different names for the same approved vaccine. This is a Phase III trial which will enroll up to 56,000 people worldwide
What is required of Study Participants?
Participants will be randomly assigned to get one of two vaccinations:
- mRNA-1010: The trial vaccine
- Fluarix®/Influsplit®: A vaccine approved to prevent seasonal flu infections.
Participants will have a single follow-up blood draw and be asked to periodically report if any symptoms of flu-like illness occur. These will be periodically reported with the use of electronic diaries and phone calls.
Visit Schedule and Compensation
Screening (In-clinic) Patient Compensation - $110
An eligibility assessment which will include:
- a blood draw
- physical exam
- medication review
- review of medical history
- Pregnancy test for female participants
Day 1 (Dose Visit) Patient Compensation - $110
Dose Visit will include:
- a blood draw
- medication and medical history review
- physical exam
- pregnancy test or FSH test for female participants
- intramuscular dose of study medication
- electronic diary training
Electronic Diaries
Patient Compensation - $5 per week (during flu season) You will be asked to fill out twice a week eDiary entries on your mobile device until the end of flu season. You will be asked to report any symptoms of influenza like illness. These entries will be brief. Study participants are compensated $5 a week for eDiary entries.
Day 8 (Phone Call) Patient Compensation - $30
Phone call will include:
- Discuss any health or medication changes.
- Review the symptom reporting of eDiary entries.
Day 29 (In-clinic) Patient Compensation - $110
Day 29 Visit will include:
- Discuss any health or medication changes.
- Review the symptom reporting of eDiary entries.
- Blood sample collection for immune response tests.
Unscheduled (In-clinic) Patient Compensation - $50
If you report flu-like illness, you may be asked to come in for an unscheduled clinic visit. Unscheduled visits will include:
- Discuss any changes in your health and/or medications.
- Review respiratory and flu-like illness symptoms.
- Vitals
Day 90 (Phone Call) Patient Compensation - $30
Phone call will include:
- Discuss any health or medication changes.
- Review the symptom reporting of eDiary entries.
Day 181 (Phone Call) Patient Compensation - $30
Phone call will include:
- Discuss any health or medication changes.
- Review the symptom reporting of eDiary entries.
End of flu Season (Phone Call) Patient Compensation - $30
Phone call will include:
- Discuss any health or medication changes.
- Review the symptom reporting of eDiary entries.
Are you interested in participating in this study?
How to apply:
- Fill out the form below.
- A qualified member of our team will reach out to provide an overview of the studies for which you may qualify.
- We will ask you health-related questions to determine your eligibility for our current studies and you will have an opportunity to ask us any questions you have.
- We can set up your first visit and we can place you on the contact list for any future studies you may be interested in.
Our recruitment specialists are here to assist you through every step of the enrollment process! You can reach us directly at 256-403-7711.
We look forward to speaking with you!
Enrolling clinical trials
Our mission is to carry out safe, ethical, and dependable clinical research. Pinnacle invites you to be part of our efforts to advance new treatments and make a meaningful impact in the community. To participate, fill out a patient participation form, and a qualified medical team member will contact you after review for a brief consultation. This consultation will help determine your eligibility for an ongoing or upcoming study. Participants receive expert care related to the study and are compensated for their time and travel expenses.
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Clinical Trial Benefits
Pinnacle Research Group was established in 1998 and is at the cutting edge of clinical trials in the USA. We conduct phase I-IV clinical drug and device studies over a broad therapeutic area, with particular interest in early phase development projects. We have enrolled thousands of participants in hundreds of studies. Our expert research team has experience in studies across the research spectrum, from first-in-human and early phase protocols, to late phase pivotal studies. Our highly trained staff and decades of experience make us a valued resource for participants, physicians, and our pharmaceutical industry partners. Our participants decide to join a clinical trial for a range of reasons including:
Early access
Gain access to new medicines and cutting-edge therapies
Comprehensive knowledge
Benefit from a thorough review of your medical history and expert care throughout the study
Greater good
Advance medical science for those living with chronic illnesses. An opportunity to participate in something bigger than ourselves.
5 Things to Consider
Joining a clinical trial is an important decision and it is important to carefully consider if trial participation is right for you. There are benefits of participation, including early access to novel medications, access to expert medical care, and the chance to help in the development of something that may benefit others. Risks associated with study participation include adverse events associated with typical medical procedures (such as blood draws) as well as potential side effects of the medication/treatment. Please take a moment to read through our list of considerations before enrolling in a clinical trial.
Participating in a clinical trial is an important responsibility. Each participant has a role in the outcome of a study. It is important that you follow the study instructions so that the information received is accurate, which is critical to study outcomes.
1
Is this your decision?
It is imperative that you make the decision to be a clinical trial participant independently and do not feel pressured to be involved. This doesn’t mean that you shouldn’t talk the decision over with family and friends, but the final decision must be yours alone.
2
Have you considered the risks?
At Pinnacle Research, we go to great lengths to ensure the safety, comfort, and satisfaction of our participants. Treatments tested at our facility have been carefully considered and tested before making it to our facility. However, there may be risks associated with experimental trials. Before you participate in a study, be sure you’ve talked with your doctor, as well as one of our clinical research professionals, so that you fully understand the nature the trial.
3
Do you have the time?
Most clinical trials involve routine testing and observation. Depending on the study, you may be required to complete multiple visits to our clinic, or for certain studies may even stay overnight. While not every trial will involve such extensive time commitments, you will want to be sure your schedule, daily obligations, and travel capabilities allow you to fully participate.
4
Do you fit the profile?
Most clinical trials are looking for participants who fit a very specific profile. If you don’t meet the requirements you may not be able to enroll.
5
Do you trust the clinic performing the trial?
We employ one of the most experienced and highly qualified research teams in the country. Our facility is state-of-the-art, and our working practice on all clinical trials places the safety and comfort of participants as the highest priority. Our facility is regularly and independently reviewed (including the FDA). We have an exemplary record and have never been given cause for remediation. If you have any questions, don’t hesitate to call us. A fully qualified research team member can answer any questions you have about an upcoming trial. If you are considering becoming a clinical trial participant it is essential that you trust the clinicians that will be caring for you. We work hard to build trust with all of our participants and to work ethically and transparently.
Why Choose Pinnacle?
Since opening our doors in 1998 our highly qualified research team has participated in over 500 studies and has provided results obtained at the highest level of expertise, safety, and ethics. Clinical trials are conducted in our state-of-the-art, Phase I to IV facility in Anniston, Alabama. Our facility can host in-patient and outpatient studies and includes a 7,300ft² phase one unit with 16 beds. We have solid relationships with pharmaceutical companies, with our patients, with our local community, and with medical professionals. Get in touch to see how we can advance your treatment solutions.
About Pinnacle500+Clinical trials completed
#1Enrolling site for many trials
5000+Participants
24+Years of experience