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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
51
Sterile liquid for injection
Sterile liquid for injection
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
...and 9 more locations
Proportion of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Time frame: Up to 7 days after each dose administration
Proportion of Participants with Unsolicited Adverse Events (AEs)
Time frame: Up to 28 days after each dose administration
Proportion of Participants with Serious Adverse Events (SAEs) and Medically-Attended AEs
Time frame: Up to 1 year after the last dose administration
Geometric mean titer (GMT) of Serum Anti-hMPV and Anti-PIV3 Neutralizing Antibodies
Time frame: Day 29, 57, 85, and 224 for adults; Day 29 and 85 for pediatric participants
Geometric Mean Ratio (GMR) of Post-Baseline/Baseline Titers of Serum Anti-hMPV and Anti-PIV3 Neutralizing Antibodies
Time frame: Day 29, 57, 85, and 224 for adults; Day 29 and 85 for pediatric participants
Proportion of Participants with ≥2-Fold and ≥4-Fold Increases in Serum Anti-hMPV or Anti-PIV3 Neutralizing Antibody Titer from Baseline
Time frame: Day 29, 57, 85, and 224 for adults; Day 29 and 85 for pediatric participants
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