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
Matrix Clinical Research
Los Angeles, California, United States
Meridian Clinical Research
Washington D.C., District of Columbia, United States
Main Study: Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Time frame: Up to Day 120 (7 days after each injection)
Main Study: Number of Participants with Unsolicited Adverse Events (AEs)
Time frame: Up to Day 141 (28 days after each injection)
Main Study: Number of Participants with Medically-Attended Adverse Events (MAAEs)
Time frame: Day 1 through Day 730
Main Study: 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
Part B Extension: Number of Participants with MAAEs, AESIs and SAEs
Time frame: Day 1 of the Extension to end of study (EoS) (up to 3 years)
Part B Extension: Number of Participants with Lower Respiratory Tract Illness (LRTI), Severe LRTI, Very Severe LRTI, and Hospitalizations Associated with RSV or hMPV
Time frame: Day 1 of the Extension to EoS (up to 3 years)
Main Study: Number of Participants with Respiratory tract Illness (RTI), LRTI, Severe LRTI, Very Severe LRTI, and Hospitalizations Associated with RSV or hMPV
Time frame: Day 1 through Day 730
Main Study (Parts A and B): Geometric Mean Titer (GMT) of Serum RSV and hMPV Neutralizing Antibodies
Time frame: Baseline up to Month 12
Main Study (Part C): GMT of Serum RSV Neutralizing Antibodies
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Solution for injection
DM Clinical Research- River Forest
Melrose Park, Illinois, United States
MedPharmics - Platinum - PPDS
Lafayette, Louisiana, United States
Duke Vaccine and Trials Unit
Durham, North Carolina, United States
Velocity Clinical Research - Providence
Providence, Rhode Island, United States
Palmetto Pediatrics, PA
North Charleston, South Carolina, United States
Vanderbilt Vaccine Research Program
Nashville, Tennessee, United States
CyFair
Houston, Texas, United States
Pediatric Associates
Houston, Texas, United States
...and 7 more locations
Time frame: Baseline up to Month 12
Main Study (Parts A and B): Geometric Mean Concentration (GMC) of Serum RSV F- and hMPV F-Binding Antibodies
Time frame: Baseline up to Month 12
Main Study (Part C): GMC of Serum RSV F-Binding Antibodies
Time frame: Baseline up to Month 12
Main Study: Geometric Mean Fold-Rise (GMFR) of Postbaseline/baseline Neutralizing Antibody Titers and Binding Antibody
Time frame: Month 12
Main Study: Number of Participants with Vaccine-specific T-cell Responses Measured by Flow Cytometry
Time frame: Baseline up to Month 12
Part B Extension: Geometric Mean Titer (GMT) of Serum RSV and hMPV Neutralizing Antibodies
Time frame: Day 1 of the Extension up to EoS (up to 3 years)
Part B Extension: Geometric Mean Concentration (GMC) of Serum RSV F- and hMPV F-Binding Antibodies
Time frame: Day 1 of the Extension up to EoS (up to 3 years)
Part B Extension: Geometric Mean Fold-Rise (GMFR) of Postbaseline/baseline Neutralizing Antibody Titers and Binding Antibody
Time frame: Day 1 of the Extension up to EoS (up to 3 years)
Part B Extension: Number of Participants with Vaccine-specific T-cell Responses Measured by Flow Cytometry
Time frame: Day 1 of the Extension up to EoS (up to 3 years)