Moderna

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

1

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

Check Your Child's Eligibility

We’ll check to see if your child is eligible by asking you some questions.

Get Started

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

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

Currently Inactive

  • (Awaiting confirmation) Omaha, Nebraska, United States
  • (Awaiting confirmation) Binghamton, New York, United States
  • (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 (FAQ)

Check Your Child's Eligibility

We’ll check to see if your child is eligible by asking you some questions.

Get Started