A Study of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in Children 2 to <18 Years of Age at High Risk of Respiratory Syncytial Virus
- Conditions
- Respiratory Syncytial Virus
- Interventions
- Biological: Placebo
- Registration Number
- NCT06097299
- Lead Sponsor
- ModernaTX, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 346
Part A Cohort 1:
- 2 to <5 years of age at Day 1.
- Healthy, or with stable chronic conditions increasing the risk of RSV disease, per the clinical judgment of the Investigator.
Cohort 2:
- 5 to <18 years of age at Day 1.
- Participants with stable chronic conditions increasing the risk of RSV disease.
- Female participants of child-bearing potential may be enrolled in the study, if the participant: 1) has a negative urine pregnancy test at Screening and on the day of injection (Day 1); 2) has practiced adequate contraception or has abstained from all activities that could lead to pregnancy for 28 days prior to Day 1; 3) has agreed to continue adequate contraception through 90 days following injection; and 4) is not currently breastfeeding.
Part B: Cohort 1 Re-enrollment
Participants are eligible to be included in the study only if all of the following criteria apply:
- Enrolled and dosed in Part A of Cohort 1; either reached EoS for Part A or were dosed and subsequently discontinued from study for various reasons. This includes participants who were lost to follow-up, if they can be re-engaged.
- Participant's parent(s)/LAR(s) has provided written informed consent for participation in this study.
Key Exclusion Criteria (All Cohorts):
- Acutely ill or febrile (temperature ≥38.0°Celsius [100.4°Fahrenheit]) within 72 hours prior to or at the Screening Visit or Day 1.
- History of a diagnosis or condition that, in the judgment of the Investigator, may affect study assessment or compromise participant safety.
- Has received or plans to receive any licensed or authorized vaccine ≤14 days prior to the study vaccine injection (Day 1) or plans to receive a licensed or authorized vaccine within 14 days after the study vaccine injection.
- Receipt of any prior systemic immunosuppressants. Short courses (<7 days) of oral corticosteroids are allowed if completed at least 3 months prior to enrollment.
- Receipt of RSV monoclonal antibodies within 6 months prior to enrollment in the study.
- Participated in an interventional clinical study within 28 days (6 months for a study assessing a product unlicensed/unauthorized in this age group in country of residence at time of enrollment) prior to the day of enrollment or plans to do so while enrolled in this study.
Part B: Cohort 1 Re-enrollment
- Participant is currently enrolled in another interventional clinical study.
Note: Other protocol-defined inclusion and exclusion criteria may apply.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part A: Cohort 2 (5 to <18 Years of Age) mRNA-1345 Participants 5 to \<18 years of age will receive a single IM injection of mRNA-1345 on Day 1. Part A and Part B: Cohort 1 (2 to <5 Years of Age) mRNA-1345 Part A: Participants 2 to \<5 years of age will receive either a single intramuscular (IM) injection of mRNA-1345 or placebo on Day 1. Part B: Participants will have the option to be re-enrolled into a 6-month safety-follow up period. Part A and Part B: Cohort 1 (2 to <5 Years of Age) Placebo Part A: Participants 2 to \<5 years of age will receive either a single intramuscular (IM) injection of mRNA-1345 or placebo on Day 1. Part B: Participants will have the option to be re-enrolled into a 6-month safety-follow up period.
- Primary Outcome Measures
Name Time Method Part A: Number of Participants With Serious Adverse Events (SAEs) Day 1 through EOS (Month 6) Part A: Number of Participants With AEs Leading to Discontinuation Day 1 through EOS (Month 6) Part A: Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) Up to 7 days postinjection Part A: Number of Participants with Unsolicited Adverse Events (AEs) Up to 28 days postinjection Part A: Number of Participants With Medically Attended AEs (MAAEs) Day 1 through end of study (EOS; Month 6) Part A: Number of Participants With Adverse Events of Special Interest (AESIs) 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 Day 1 through EOS (Month 6)
- Secondary Outcome Measures
Name Time Method Part A: Geometric Mean Titer (GMT) of Serum RSV Neutralizing Antibody Day 1, Day 29, and Month 6 Part A: Geometric Mean Concentration (GMC) of Serum RSV Prefusion F Binding Antibody Day 1, Day 29, and Month 6 Part A: Geometric Mean Fold Rise (GMFR) of Postbaseline/Baseline Neutralizing Antibody Titers and Binding Antibody Concentrations Baseline to Day 29 and Month 6 Part A: Number of Participants With Seroresponse in RSV Neutralizing Antibody Baseline to Day 29 and Month 6 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.
Part B: Number of Participants With AESIs Day 1 through EOS (Month 6) Part B: Number of Participants With SAEs Day 1 through EOS (Month 6)
Trial Locations
- Locations (50)
Javara, Inc.
🇺🇸Fayetteville, Georgia, United States
ASCADA Research, LLC - Family Medicine
🇺🇸Fullerton, California, United States
Velocity Clinical Research Metairie
🇺🇸Metairie, Louisiana, United States
Pediatric & Adolescent Center
🇺🇸Southgate, Michigan, United States
Senders Pediatrics
🇺🇸South Euclid, Ohio, United States
Village Pediatrics
🇺🇸Plano, Texas, United States
West Houston Clinical Research Service
🇺🇸Houston, Texas, United States
CEVAXIN Chorrera
🇵🇦La Chorrera, Panama
Velocity Clinical Research-Kansas City
🇺🇸Overland Park, Kansas, United States
Alliance for Multispeciality Research, LLC
🇺🇸El Dorado, Kansas, United States
Clinical Research Institute
🇺🇸Minneapolis, Minnesota, United States
CEVAXIN Avenida Mexico
🇵🇦Panamá, Panama
CEVAXIN 24 de Diciembre
🇵🇦Ciudad de Panamá, Panama
Velocity Clinical Research, Phoenix
🇺🇸Phoenix, Arizona, United States
Ark Clinical Research
🇺🇸Long Beach, California, United States
Headlands Research - Scottsdale
🇺🇸Scottsdale, Arizona, United States
Velocity Clinical Research - Banning
🇺🇸Banning, California, United States
Kissimmee Clinical Research
🇺🇸Kissimmee, Florida, United States
Peninsula Research Associates (PRA)
🇺🇸Rolling Hills Estates, California, United States
Med-Care Research
🇺🇸Miami, Florida, United States
Accel Clinical
🇺🇸Largo, Florida, United States
D&H Doral Research Center, LLC
🇺🇸Doral, Florida, United States
SEC Clinical Research
🇺🇸Pensacola, Florida, United States
D&H Tamarac Research Center
🇺🇸Tamarac, Florida, United States
Clinical Research Prime
🇺🇸Idaho Falls, Idaho, United States
CenExel iResearch, LLC
🇺🇸Savannah, Georgia, United States
Velocity Clinical Research-Primary Pediatrics, Macon
🇺🇸Macon, Georgia, United States
Velocity Clinical Research - Boise
🇺🇸Meridian, Idaho, United States
Velocity Clinical Research - Lafayette
🇺🇸Lafayette, Louisiana, United States
Great Lakes Research Institute
🇺🇸Southfield, Michigan, United States
Velocity Clinical Research, Gulfport
🇺🇸Gulfport, Mississippi, United States
Velocity Clinical Research-Binghamton
🇺🇸Binghamton, New York, United States
Velocity Clinical Research- Albuquerque
🇺🇸Albuquerque, New Mexico, United States
University of Rochester Medical Center (URMC) - Golisano Children's Hospital (GCH)
🇺🇸Rochester, New York, United States
The Children's Hospital of Philadelphia - Pediatrics
🇺🇸Philadelphia, Pennsylvania, United States
Velocity Clinical Research - Providence
🇺🇸Providence, Rhode Island, United States
DM Clinical Research - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
REX Clinical Trials, LLC
🇺🇸Beaumont, Texas, United States
Javara Inc (Conroe)
🇺🇸Conroe, Texas, United States
Tribe Clinical Research
🇺🇸Simpsonville, South Carolina, United States
DM Clinical Research - CyFair
🇺🇸Houston, Texas, United States
Javara Inc/Texas Health Care, PLLC d/b/a/ Privia Medical Group-North Texas
🇺🇸Stephenville, Texas, United States
Victoria Clinical Research Group
🇺🇸Victoria, Texas, United States
Velocity Clinical Research - Salt Lake City
🇺🇸West Jordan, Utah, United States
PI-Coor Clinical Research, LLC
🇺🇸Annandale, Virginia, United States
Clinical Research Partners
🇺🇸Richmond, Virginia, United States
National Clinical Research, Inc.
🇺🇸Richmond, Virginia, United States
Accel Research Sites - Nona Pediatric Center
🇺🇸Orlando, Florida, United States
Coastal Pediatric Research
🇺🇸Charleston, South Carolina, United States
Elligo Clinical Research Center
🇺🇸Austin, Texas, United States