A clinical trial of an investigational seasonal flu vaccine for adults

Seasonal influenza, also known as the seasonal flu, is a respiratory illness caused by the influenza virus. This virus infects the lungs and breathing passages and is easily spread from person to person. Every year, seasonal flu causes approximately 30,000 to 50,000 deaths and over 380,000 hospitalizations in the United States. Although peaking in winter months, flu activity lasts as late as May and can be detected year-round. Seasonal influenza more severely affects people 65 years of age and older.

Clinical trials are carefully controlled scientific studies that evaluate how well investigational or modified medicines may treat or prevent diseases in people. Clinical trials are conducted to answer questions such as:

• Is the investigational treatment or vaccine safe enough to outweigh the risks
• What is the best dose needed for the investigational treatment or vaccine to work?
• How often should the investigational treatment or vaccine be given?
• How effective is the investigational treatment or vaccine at treating or preventing symptoms or the condition?

A clinical trial follows a protocol that has been approved by regulatory agencies to ensure patients’ and trial participants’ safety. The protocol outlines the types of trial participants to include, the schedule of visits and procedures, safety precautions, and what and how data will be analyzed.

Clinical trials are conducted in phases. Each phase of the trial has a different purpose and helps scientists answer different questions:

• In Phase 1 trials, researchers test a new vaccine, drug, or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
• In Phase 2 trials, the investigational vaccine, drug, or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
• In Phase 3 trials, the investigational vaccine, drug, or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
• In Phase 4 trials, post marketing studies delineate additional information including the drug’s risks, benefits, and optimal use.

Reference: https://www.ciscrp.org/education-center/important-information/#faq

Clinical trials and trial volunteers are vital to advancing research of an investigational vaccine that may potentially protect people of all ages and from all backgrounds.

Given that different populations and ages can respond differently to medical therapies, it is extremely important that this clinical trial include people of all ages, sexes, races, and ethnicities to ensure the investigational vaccine is safe and effective for everyone to use.

Qualified participants will receive payment for their trial-related time and travel.

The investigational vaccine being evaluated in this clinical trial is called mRNA-1010. Unlike vaccines that are made from weakened or killed viruses, mRNA-1010 is made from messenger RNA (mRNA), an instructional molecule that naturally occurs in the body and tells cells how to make specific protein. The goal of this vaccine is that the protein will trigger the body’s immune system to create the antibodies it needs to fight the real influenza virus, the virus that causes the seasonal flu. You cannot get the seasonal flu from the mRNA-1010 investigational vaccine.

You can check if you are potentially eligible for this trial by completing a set of screening questions. You can find these on this web page by clicking the ‘Get Started’ button.

Participation is voluntary. You have the right to end your participation in the clinical trial at any time for any reason, or no reason at all. The clinical trial doctor or sponsor also has the right to discontinue a participant at any time for that person’s safety or if the participant no longer meets the trial requirements.