A clinical trial of a flu and COVID-19 combination vaccine for adults ages 18–79

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.

COVID-19 is a respiratory illness caused by the SARS-CoV-2 virus. Common symptoms are similar to the flu and include fever, cough, and tiredness. More serious symptoms include difficulty breathing and, in rare cases, death. COVID-19 was declared a public health emergency in 2020 and was estimated to be responsible for over 3 million deaths worldwide in 2020.

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.

Often vaccines for viruses are made from a weakened or inactive (not live) virus, but the mRNA-1083 investigational vaccine is different. It is made from an instructional molecule called mRNA. mRNA makes proteins inside your cells that mimic part of the virus, triggering the body’s immune system to create antibodies. Through this natural process, it is hoped that the immune system can create the antibodies it needs to fight the real seasonal flu or COVID-19 viruses if they are ever encountered. You cannot get the seasonal flu or COVID-19 from the mRNA-1083 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.