The purpose of this study is to assess the safety and immunogenicity of mRNA-1365, an mRNA vaccine targeting respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) and mRNA-1345, an mRNA vaccine targeting RSV, in participants aged 5 months to \<24 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
186
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Time frame: Up to Day 120 (7 days after each injection)
Number of Participants with Unsolicited Adverse Events (AEs)
Time frame: Up to Day 141 (28 days after each injection)
Number of Participants with Medically-Attended Adverse Events (MAAEs)
Time frame: Day 1 through Day 730
Number of Participants with Adverse Event of Special Interests (AESIs), Serious Adverse Events (SAEs) and Adverse Events Leading to Discontinuation
Time frame: Day 1 through Day 730
Number of Participants with Respiratory Tract Illness (RTI), Lower Respiratory Tract Illness (LRTI), Severe LRTI, Very Severe LRTI, and Hospitalizations Associated with RSV or hMPV
Time frame: Day 1 through Day 730
Parts A and B: Geometric Mean Titer (GMT) of Serum RSV and hMPV Neutralizing Antibodies
Time frame: Baseline up to Month 12
Part C: GMT of Serum RSV Neutralizing Antibodies
Time frame: Baseline up to Month 12
Parts A and B: Geometric Mean Concentration (GMC) of Serum RSV F- and hMPV F-Binding Antibodies
Time frame: Baseline up to Month 12
Part C: GMC of Serum RSV F-Binding Antibodies
Time frame: Baseline up to Month 12
Geometric Mean Fold-Rise (GMFR) Postbaseline/baseline Neutralizing Antibody Titers
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Solution for injection
Matrix Clinical Research
Los Angeles, California, United States
Los Angeles Children's Hospital
Los Angeles, California, United States
Velocity Clinical Research, Denver
Englewood, Colorado, United States
Meridian Clinical Research
Washington D.C., District of Columbia, United States
Meridian Clinical Research
Washington D.C., District of Columbia, United States
University Of Florida Health Science Center
Jacksonville, Florida, United States
Accel Research Sites - Nona Pediatric Center
Orlando, Florida, United States
Clinical Research Prime
Idaho Falls, Idaho, United States
MedPharmics - Platinum - PPDS
Lafayette, Louisiana, United States
Umass Memorial Medical Center
Worcester, Massachusetts, United States
...and 40 more locations
Time frame: Baseline up to Month 12
Number of Participants with Vaccine-specific T-cell Responses Measured by Flow Cytometry
Time frame: Baseline up to month 12