National Foundation for Infectious Diseases

This trial is not actively recruiting.

This trial has completed recruitment on this platform, and is no longer accepting new referrals.

A Respiratory Syncytial Virus (RSV) vaccine study for children

A research study conducted by Moderna is testing an investigational vaccine that may protect people from RSV. RSV is a common cause of respiratory tract infection and may cause severe disease, especially in younger children and older adults.

Trial ID: NCT04528719-

Trial Details

The mRNA-1345-P101 study is evaluating the safety and immune response of an investigational vaccine, called mRNA-1345, to protect against RSV.

RSV can cause infections of the lungs and respiratory tract. Symptoms can be similar to a cold, and may include runny nose, sore throat, cough, and headache. However, RSV can lead to serious conditions like pneumonia especially for younger children and older adults. Currently there is not an approved vaccine for RSV.

Estimated Enrollment

40 Participants

Phase

Eligibility Criteria

Participants must:

Be between the ages of 12 and 59 months (1 – less than 5 years old)
Be in good health
Have received routine immunizations appropriate for their age

Participants must not:

Have participated in another trial in the past month
Have a history of epilepsy or febrile seizures

What to Expect

Participation in the mRNA-1345-P101 Study lasts approximately 16 months (or through the RSV season after the last vaccination) and includes phone calls and up to eleven visits to the study site.

Your child will be given three injections in the upper arm –the injections are approximately 56 days apart. Your child has a chance of receiving either the mRNA-1345 study vaccine or the placebo. By using a placebo, which has no impact on the body, medical researchers are able to understand if the study vaccine is effective in preventing RSV.
You and your child will have a mix of in-person and phone visits with the study doctor to monitor for any symptoms after injections. During these visits and phone calls, the study doctor and medical staff will check how your child is feeling and ask for updates on their health.
You will be asked to use an eDiary app on your smartphone or a provided smartphone to report any symptoms your child experiences.
Your child will be closely monitored by the study team if any symptoms or adverse events are reported at any time throughout their participation.

Insurance is not needed to join this clinical trial, and compensation for your time will be available.

You will need to bring your child to one of the study clinics taking part in this clinical trial.

Frequently Asked Questions (FAQs)

What is Respiratory Syncytial Virus (RSV)?

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

What is a clinical research study?

Clinical research studies include scientifically evaluated plans, or protocols, that outline how to test if a potential new medication or vaccine is safe and/or effective in people. All investigational medications and vaccines must be tested in clinical research studies before they can be submitted for approval by regulatory authorities. A clinical research study is conducted by doctors and researchers who follow strict guidelines to ensure the safety and wellbeing of the study volunteers who participate. Although side effects can occur in any clinical trial, the study is designed to minimize the risk and you will be monitored closely.

What are the phases of clinical research?

Clinical trials are conducted in phases. The trials at each phase have a different purpose and help 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 study 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 study 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 research studies and study volunteers are vital to creating a vaccine that will protect people of all ages and from all backgrounds against this devastating disease.

Given that certain populations and ages can respond differently to medical therapies, it is extremely important that this clinical research study include children of all ages, genders, races and ethnicities to ensure the vaccine is safe and effective for everyone to use.

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

Yes, compensation for your family’s time will be available. We realize it takes time to come for study visits, so we want to make sure this is not too much of a burden for you and your child. The study site will review these details with you.

Does the mRNA-1345 study vaccine contain a live virus?

No, the mRNA-1345 study vaccine does not contain a live virus. Often vaccines for viruses are made from a weakened or inactive (not live) virus, but the mRNA-1345 study vaccine is different. It is 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 is thought to help the body’s immune system protect itself if you ever come in contact with RSV.

What is a placebo?

In order to understand if the study vaccine works, medical researchers are comparing the mRNA-1345 study vaccine to a saltwater placebo. A placebo looks like the study vaccine being tested but does not contain the study vaccine.

How can I check to see if my child is eligible for this trial?

You can check if your child is 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 my child quit the trial at any time?

Study volunteers have the right to drop out of the study at any time for any reason, or no reason at all. The study doctor or sponsor also has the right to discontinue a study volunteer at any time for the volunteer’s safety, or if the study volunteer no longer meets the study requirements.