Clinical Connection

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

A Human Metapneumonovirus (hMPV) and Parainfluenza Virus Type 3 (PIV3) vaccine study for children

A research study conducted by Moderna is testing an investigational vaccine that may protect children from two very common viruses called Human Metapneumonovirus (hMPV) and Parainfluenza Virus Type 3 (PIV3), which are known to cause respiratory disease.

Trial ID: NCT04144348

Trial Details

This study is evaluating an investigational combination vaccine, called mRNA-1653, to protect against hMPV and PIV3. Both hMPV and PIV3 are known to cause respiratory disease in people of all ages, often in children.

This study will evaluate the safety and immune responses of the mRNA-1653 vaccine when administered to children ages 1 year and less than 5 years of age who have previously had an infection with both hMPV and PIV3 (this could have been just what seemed like a mild common cold).

There are no approved vaccines to prevent hMPV or PIV3 infections. A safe and effective vaccine against hMPV and PIV3 has the potential to substantially improve the health of young children.

Estimated Enrollment

36 Participants

Phase

Eligibility Criteria

Participants must:

Be between the ages of 12 and 59 months (1 – less than 5 years old)
Previously had a few common colds
Have received routine immunizations appropriate for their age

Participants must not:

Have tested positive for COVID-19 or been in contact with anyone diagnosed with COVID-19 within 2 weeks prior to study vaccine administration
Have participated in another trial in the past month

What to Expect

Participation in the mRNA-1653-P102 Study lasts approximately 14 months and includes phone calls and up to eight visits to the study site.

Your child will be given two injections in the upper arm or thigh – about 57 days apart. Your child has a chance of receiving either the mRNA-1653 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 hMPV and PIV3.
You and your child will be asked to return to the study site eight times.
You and your child will have monthly phone and / or clinic visits with the study doctor. During these 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. Sites are located in:

Actively Recruiting

Norfolk, Nebraska, United States
Liverpool, New York, United States
East Syracuse, New York, United States
Omaha, Nebraska, United States
Layton, Utah, United States
El Dorado, Kansas, United States
Sioux Falls , South Dakota, United States
Newton, Kansas, United States
Binghamton, New York, United States
Birmingham, Alabama, United States
Metarie, Louisiana, United States
Washington, DC, United States
Galveston, Texas, United States
Lincoln, Nebraska, United States

Not yet Recruiting

(Awaiting confirmation) Dayton, Ohio, United States

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

Frequently Asked Questions (FAQs)

What are Human Metapneumonovirus (hMPV) and Parainfluenza Virus Type 3 (PIV3)?

Human Metapneumovirus (hMPV) and the Parainfluenza Virus Type 3 (PIV3) are very common viruses that cause upper respiratory infection (like a cold) in people of all ages, often in children. In some young children, hMPV and PIV3 can cause serious lung disease.

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.

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-1653 study vaccine contain a live virus?

Often vaccines for viruses are made from a weakened or inactive (not live) virus, but the mRNA-1653 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 HMPV or PIV3.

What is a placebo?

In order to understand if the study vaccine works, medical researchers are comparing the mRNA-1653 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.