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
NCT ID: NCT04144348
Last Updated: 2023-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
51 participants
INTERVENTIONAL
2019-11-04
2022-12-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
TRIPLE
Study Groups
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mRNA-1653, Adult participants
Participants will receive 1 of 2 doses of mRNA-1653, administered via intramuscular injection, on Day 1 and Day 57.
mRNA-1653
Sterile liquid for injection
mRNA-1653 Pediatric participants
Participants will receive 1 of 2 possible doses of mRNA-1653, administered via intramuscular injection, on Day 1 and Day 57.
mRNA-1653
Sterile liquid for injection
Placebo, Adult participants
Participants will receive mRNA-1653-matching placebo, administered via intramuscular injection, on Day 1 and Day 57.
Placebo
Sterile liquid for injection
Placebo, Pediatric participants
Participants will receive mRNA-1653-matching placebo, administered via intramuscular injection, on Day 1 and Day 57.
Placebo
Sterile liquid for injection
Interventions
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mRNA-1653
Sterile liquid for injection
Placebo
Sterile liquid for injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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
Exclusion Criteria
* Acutely ill or febrile (temperature ≥38.0℃/100.4°F, regardless of route) on the day of the first vaccination
* Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care
* Receipt of, or plans for receipt of an inactivated vaccine(s) 14 days prior to though 14 days following each study injection or a live virus vaccine(s) within 28 days prior to, or plans to through 28 days following each study injection. The exception is any COVID-19 vaccine (regardless of type of vaccine) that becomes available to the participant during the study; efforts should be made to space study vaccinations and COVID-19 vaccinations by at least 7 and preferably 14 days, but COVID-19 vaccinations should not be delayed.
* Any chronic administration of an immunosuppressant or other immune modifying drug
* Prior administration of investigational agent using lipid nanoparticle formulations
* Donation of blood or blood products ≥450 mL within 28 days of the Screening visit (for the Adult Cohort)
* Intravenous blood products (red cells, platelets, immunoglobulins) within 3 months prior to enrollment
* Participated in an interventional clinical trial within 28 days prior to the day of enrollment, or plans to do so while enrolled in this trial
* Has a family member or household contact who is an employee of the research center or otherwise involved with the conduct of the study
12 Months
49 Years
ALL
Yes
Sponsors
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ModernaTX, Inc.
INDUSTRY
Responsible Party
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Locations
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Central Research Associates Inc
Birmingham, Alabama, United States
Meridian Clinical Research
Washington D.C., District of Columbia, United States
Clinical Research Prime
Idaho Falls, Idaho, United States
Heartland Research Associates LLC
El Dorado, Kansas, United States
Heartland Research Associates LLC
Newton, Kansas, United States
MedPharmics
Metairie, Louisiana, United States
Meridian Clinical Research, LLC
Lincoln, Nebraska, United States
Meridian Clinical Research
Norfolk, Nebraska, United States
Meridian Clinical Research, LLC
Omaha, Nebraska, United States
UHS Primary Care
Binghamton, New York, United States
Child Healthcare Associates
Liverpool, New York, United States
Child Healthcare Assoc.
Syracuse, New York, United States
Duke Vaccine and Trials Unit
Durham, North Carolina, United States
Ohio Pediatric Research Assn Inc
Dayton, Ohio, United States
Sanford Children's Hospital
Sioux Falls, South Dakota, United States
Crossroads Clinical Research
Corpus Christi, Texas, United States
University of Texas Medical Branch (UTMB)
Galveston, Texas, United States
Tekton Research Inc
San Antonio, Texas, United States
Tanner Clinic
Layton, Utah, United States
Countries
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Other Identifiers
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mRNA-1653-P102
Identifier Type: -
Identifier Source: org_study_id
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