A clinical trial of investigational flu, RSV, and COVID-19 vaccines for adults 50–75 years of age

Trial ID: mRNA-1230-P101

The Trio P101 Trial is a Phase 1 clinical trial conducted by Moderna to determine whether investigational vaccines can help protect adults 50 to 75 years of age from influenza (flu), respiratory syncytial virus (RSV), and COVID-19. The combination vaccines being studied in this clinical trial take 2 or more investigational vaccines that could potentially be given individually and put them into 1 injection. It is hoped that the investigational combination vaccines can potentially reduce the number of injections you need for protection against common viruses like flu, RSV, and COVID-19.

Trial Details

The purpose of the Trio P101 Trial is to assess the safety of and immune responses to investigational vaccines aimed at preventing illness due to 3 common viruses: flu, RSV, and COVID-19 in adults 50 to 75 years of age. Flu, RSV, and COVID-19 are all respiratory illnesses. Flu is caused by the influenza virus. COVID-19 is caused by the SARS-CoV-2 virus. You may be less familiar with RSV, which is one of the most common causes of lower respiratory tract infections worldwide. In this trial, 5 different investigational vaccines will be evaluated. All participants will be randomly assigned to one of the groups in the trial, which will determine which investigational vaccine and dose each participant receives. Each participant will only receive 1 investigational vaccine. In this clinical trial, the investigational vaccines are:

mRNA-1010: An investigational vaccine for the prevention of flu
mRNA-1045: An investigational combination vaccine for the prevention of flu and RSV
mRNA-1273.214: An investigational booster vaccine for the prevention of COVID-19 and some of its variants
mRNA-1345: An investigational vaccine for the prevention of RSV
mRNA-1230: An investigational combination vaccine for the prevention of flu, RSV, and COVID-19

Estimated Enrollment

675 Participants

Phase

1

Eligibility Criteria

Participants must:

Be 50 to 75 years of age
Be in good health
Be fully vaccinated for COVID-19 (with or without a booster) for at least 4 months

Participants must not:

Have a pre-existing medical condition that is not stable
Have participated in another clinical trial within the past month

Site Locations

Sites are located in the cities/states identified with the red pin:

What to Expect

Participation in the Trio P101 Trial will last approximately 13 months and includes 7 visits to a trial site and up to 8 safety phone calls. Participants will be given 1 injection of an investigational vaccine in the upper arm.

Participants will use an electronic diary (eDiary) through an app on their smartphone or a provided device, to record how they are feeling for 7 days after they receive the investigational vaccine. Participants will have follow-up visits at their clinical trial site over the course of the trial for tests that will show if the investigational vaccine is working.

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 influenza (flu)?

Influenza, commonly referred to as “the flu” is a virus that can cause infections of the lungs and respiratory tract. Flu is estimated to cause 3 to 5 million cases of severe illness and up to 650,000 deaths each year.

What is Respiratory Syncytial Virus (RSV)?

RSV is a virus that can cause infections of the lungs and respiratory tract. Symptoms can be like a cold, and may include a runny nose, sore throat, cough, and headache. RSV can lead to serious conditions like pneumonia, especially for younger children and older adults.

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. The World Health Organization declared COVID-19 a pandemic in March 2020. Since that time, there have been more than 500 million cases and 6.2 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 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

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?

Compensation for your trial-related time may be provided.

Do the investigational vaccines contain a live virus?

Often vaccines for viruses are made from a weakened or inactive (not live) virus, but the investigational vaccines in the TRIO P101 Trial are different. They are made from an instructional molecule called mRNA that tells your cells how to make protein. In this case, the protein is a small part of the virus that will hopefully help the body’s immune system protect itself if you ever come in contact with the targeted virus. You cannot get a virus from the investigational vaccines.

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.