Safety and Immunogenicity of mRNA-1653, a Combined Human Metapneumovirus (hMPV) and Parainfluenza… (NCT04144348) | Clinical Trial Compass
CompletedPhase 1
Safety and Immunogenicity of mRNA-1653, a Combined Human Metapneumovirus (hMPV) and Parainfluenza Virus Type 3 (PIV3) Vaccine, in Healthy Adults, and Children 12 to 59 Months of Age With Serologic Evidence of Prior Exposure
United States51 participantsStarted 2019-11-04
Plain-language summary
This clinical study will assess the safety and immunogenicity of 2 dose levels of mRNA-1653, a combined human metapneumovirus and human parainfluenza virus type 3 vaccine, in healthy adults (18 to 49 years of age) and 2 dose levels in children (12 to 59 months of age) with serologic evidence of prior exposure. The safety profile of the adult cohort will permit enrollment of the pediatric cohort.
Who can participate
Age range
12 Months – 49 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
* Adults 18 to 49 years of age and children 12 to 59 months of age at the time of consent who, in the opinion of the Investigator, are in good health based on review of medical history and screening physical examination
* Adult participant or parent(s)/legal guardian(s) has provided written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol
* Screening laboratory values Grade ≤1
Specific inclusion criteria for adults 18 to 49 years of age:
* Body mass index (BMI) from ≥18 kg/m\^2 and ≤35 kg/m\^2
* Female participants must be either of non-childbearing potential or if of childbearing potential may be enrolled if the participant: 1) has a negative pregnancy test at Screening and on the day of vaccination, and 2) has practiced adequate contraception or has abstained from all activities that could lead to pregnancy for 28 days prior to vaccination, and 3) has agreed to continue adequate contraception through 3 months following the last vaccination, and 4) is not currently breastfeeding
Specific inclusion criteria for children 12 to 59 months of age:
* Seropositive for both hMPV and PIV3 neutralizing antibody at Screening
* Has received routine immunizations appropriate for age per the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP)
* Current height and weight above the third percentile for age
Key Exclusion Criteria:
Adult and p…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Timeframe: Up to 7 days after each dose administration
2
Proportion of Participants with Unsolicited Adverse Events (AEs)
Timeframe: Up to 28 days after each dose administration
3
Proportion of Participants with Serious Adverse Events (SAEs) and Medically-Attended AEs
Timeframe: Up to 1 year after the last dose administration