Part A: The purpose is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1345 in children aged 2 to \<5 years (Cohort 1) and in children at high risk of respiratory syncytial virus (RSV) disease 5 to \<18 years of age (Cohort 2) to inform the dose level selection for the next phase of development (Phase 3). Part B: The purpose is to provide surveillance for RSV disease for the next RSV season (6 months after re-enrollment) and safety follow-up for Cohort 1 participants that were enrolled and dosed in Part A.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
346
Sterile liquid for injection
0.9% sodium chloride (normal saline) injection
Velocity Clinical Research, Phoenix
Phoenix, Arizona, United States
Headlands Research - Scottsdale
Scottsdale, Arizona, United States
Velocity Clinical Research - Banning
Banning, California, United States
ASCADA Research, LLC - Family Medicine
Fullerton, California, United States
Ark Clinical Research
Long Beach, California, United States
Part A: Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Time frame: Up to 7 days postinjection
Part A: Number of Participants with Unsolicited Adverse Events (AEs)
Time frame: Up to 28 days postinjection
Part A: Number of Participants With Medically Attended AEs (MAAEs)
Time frame: Day 1 through end of study (EOS; Month 6)
Part A: Number of Participants With Adverse Events of Special Interest (AESIs)
Time frame: Day 1 through EOS (Month 6)
Part A: Number of Participants With Serious Adverse Events (SAEs)
Time frame: Day 1 through EOS (Month 6)
Part A: Number of Participants With AEs Leading to Discontinuation
Time frame: Day 1 through EOS (Month 6)
Part B: Number of participants With Respiratory syncytial virus-Respiratory tract disease (RSV-RTD), Respiratory syncytial virus- Lower Respiratory tract disease (RSV-LRTD), Severe RSV-LRTD, Very Severe RSV-LRTD and RSV Hospitalization
Time frame: Day 1 through EOS (Month 6)
Part A: Geometric Mean Titer (GMT) of Serum RSV Neutralizing Antibody
Time frame: Day 1, Day 29, and Month 6
Part A: Geometric Mean Concentration (GMC) of Serum RSV Prefusion F Binding Antibody
Time frame: Day 1, Day 29, and Month 6
Part A: Geometric Mean Fold Rise (GMFR) of Postbaseline/Baseline Neutralizing Antibody Titers and Binding Antibody Concentrations
Time frame: Baseline to Day 29 and Month 6
Part A: Number of Participants With Seroresponse in RSV Neutralizing Antibody
Seroresponse is defined as a postinjection titer \>4-fold-rise if Baseline is \>lower limit of quantification (LLOQ) or \>4 × LLOQ if Baseline titer is \<LLOQ in RSV neutralizing antibody titers at Day 29 and Month 6.
Time frame: Baseline to Day 29 and Month 6
Part B: Number of Participants With AESIs
Time frame: Day 1 through EOS (Month 6)
Part B: Number of Participants With SAEs
Time frame: Day 1 through EOS (Month 6)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Peninsula Research Associates (PRA)
Rolling Hills Estates, California, United States
D&H Doral Research Center, LLC
Doral, Florida, United States
Kissimmee Clinical Research
Kissimmee, Florida, United States
Accel Clinical
Largo, Florida, United States
Med-Care Research
Miami, Florida, United States
...and 40 more locations