A clinical trial of an investigational flu and COVID-19 combination vaccine for adults ages 50+

Trial ID: mRNA-1083-P301

The Duo P301 Trial is a Phase 3 clinical trial conducted by Moderna to evaluate the safety and immune response of an investigational vaccine, called mRNA-1083, which aims to protect adults against illness caused by both seasonal influenza and COVID-19.

Trial Details

The Duo P301 Trial will assess the safety of an investigational combination vaccine, called mRNA-1083, aimed at preventing seasonal flu and COVID-19 infections in adults ages 50 and older.

mRNA-1083 is an investigational combination vaccine, meaning it takes 2 investigational vaccines that could be given individually and combines them into 1 injection. It is hoped that combination vaccines like mRNA-1083 can potentially reduce the number of injections needed for protection against common viruses like the flu and COVID-19.

Seasonal flu and COVID-19 are respiratory illnesses; seasonal flu is caused by the influenza virus, and COVID-19 is caused by the SARS-CoV-2 virus. These viruses infect the lungs and breathing passages and are easily spread from person to person. Both illnesses more severely affect those ages 65 years and older.

mRNA-1083 is an investigational messenger RNA (mRNA) vaccine. mRNA vaccines aim to teach the body how to make a specific protein that may potentially help your immune system prevent or treat certain diseases. The hope is that the investigational vaccine will train your immune system cells to “remember” these proteins and help your body quickly protect against the strain of infection if exposed in the future.

Estimated Enrollment

8,000 Participants

Phase

3

Eligibility Criteria

Participants must:

Be age 50 or older
Be in generally good health
Have received the two-dose COVID-19 vaccine primary series

Participants must not:

Have received their most recent COVID-19 vaccine (primary series or booster) within the past 3 months
Have received a seasonal flu vaccine within the past 5 months
Have had COVID-19 within the past 3 months or the flu within the past 5 months

Site Locations

Participants will need to go to one of the clinics taking part in this clinical trial.

What to Expect

Participation in the Duo P301 Trial will last approximately 6 months and includes up to 3 visits to a trial site and at least 2 scheduled phone calls with the trial team.

Participants will be given 2 injections, one in each upper arm. In order to understand whether the investigational combination vaccine works well and is safe, mRNA-1083 will be compared to a Moderna COVID-19 vaccine and 2 approved seasonal flu vaccines.

Participants will be chosen by chance to receive either:

An approved Moderna COVID-19 vaccine and an approved seasonal flu vaccine; OR
The mRNA-1083 investigational vaccine and a placebo (which has no active ingredients)

All trial participants will receive the same level of quality care regardless of which vaccines they receive.

Participants will be asked to use an electronic diary (eDiary) app on their smartphone (or a provided device) to report any side effects they might experience throughout the trial.

Insurance is not needed to participate, and qualified participants will receive payment for their trial-related time and travel.

Frequently Asked Questions (FAQs)

What is seasonal flu?

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. Globally each year, there are 3 to 5 million cases of severe illness from seasonal flu and about 290,000 to 650,000 respiratory disease deaths. Seasonal influenza more severely affects people 65 years of age and older.

What is COVID-19?

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 is estimated by the World Health Organization to be responsible for nearly 7 million deaths worldwide.

What is a clinical trial?

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.

What are the phases of clinical trials?

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 an investigational 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

Why is diversity important in clinical trials?

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.

Will compensation for time be available as part of this clinical trial?

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

Does the mRNA-1083 investigational vaccine contain a live virus?

Often vaccines for viruses are often 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.

How can I check to see if I am eligible for this trial?

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.

Can I remove myself from the trial at any time?

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.

This trial is not actively recruiting.