Clinical trial NCT06097299: 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
Official title: A Phase 2, Randomized, Observer-blind Study to Evaluate the Safety, Reactogenicity, and Immunogenicity 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 Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Respiratory Syncytial Virus
Keywords: Pediatric
mRNA-1345
RSV vaccine
Viral Diseases
Messenger RNA
Moderna
Lead sponsor: ModernaTX, Inc.
Sponsor class: INDUSTRY
First posted: 2023-10-24
Enrollment: 346
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Key Inclusion Criteria:

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:

1. 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.
2. 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

1. Participant is currently enrolled in another interventional clinical study.

Note: Other protocol-defined inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Part A: Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
timeFrame: Up to 7 days postinjection
measure: Part A: Number of Participants with Unsolicited Adverse Events (AEs)
timeFrame: Up to 28 days postinjection
measure: Part A: Number of Participants With Medically Attended AEs (MAAEs)
timeFrame: Day 1 through end of study (EOS; Month 6)
measure: Part A: Number of Participants With Adverse Events of Special Interest (AESIs)
timeFrame: Day 1 through EOS (Month 6)
measure: Part A: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: Day 1 through EOS (Month 6)
measure: Part A: Number of Participants With AEs Leading to Discontinuation
timeFrame: Day 1 through EOS (Month 6)
measure: 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
timeFrame: Day 1 through EOS (Month 6)
Secondary outcomes:
measure: Part A: Geometric Mean Titer (GMT) of Serum RSV Neutralizing Antibody
timeFrame: Day 1, Day 29, and Month 6
measure: Part A: Geometric Mean Concentration (GMC) of Serum RSV Prefusion F Binding Antibody
timeFrame: Day 1, Day 29, and Month 6
measure: Part A: Geometric Mean Fold Rise (GMFR) of Postbaseline/Baseline Neutralizing Antibody Titers and Binding Antibody Concentrations
timeFrame: Baseline to Day 29 and Month 6
measure: Part A: Number of Participants With Seroresponse in RSV Neutralizing Antibody
timeFrame: Baseline to Day 29 and Month 6
measure: Part B: Number of Participants With AESIs
timeFrame: Day 1 through EOS (Month 6)
measure: Part B: Number of Participants With SAEs
timeFrame: Day 1 through EOS (Month 6)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Velocity Clinical Research, Phoenix
state: Arizona
city: Scottsdale
country: United States
facility: Headlands Research - Scottsdale
state: Arizona
city: Banning
country: United States
facility: Velocity Clinical Research - Banning
state: California
city: Fullerton
country: United States
facility: ASCADA Research, LLC - Family Medicine
state: California
city: Long Beach
country: United States
facility: Ark Clinical Research
state: California
city: Rolling Hills Estates
country: United States
facility: Peninsula Research Associates (PRA)
state: California
city: Doral
country: United States
facility: D&amp;H Doral Research Center, LLC
state: Florida
city: Kissimmee
country: United States
facility: Kissimmee Clinical Research
state: Florida
city: Largo
country: United States
facility: Accel Clinical
state: Florida
city: Miami
country: United States
facility: Med-Care Research
state: Florida
city: Orlando
country: United States
facility: Accel Research Sites - Nona Pediatric Center
state: Florida
city: Pensacola
country: United States
facility: SEC Clinical Research
state: Florida
city: Tamarac
country: United States
facility: D&H Tamarac Research Center
state: Florida
city: Fayetteville
country: United States
facility: Javara, Inc.
state: Georgia
city: Macon
country: United States
facility: Velocity Clinical Research-Primary Pediatrics, Macon
state: Georgia
city: Savannah
country: United States
facility: CenExel iResearch, LLC
state: Georgia
city: Idaho Falls
country: United States
facility: Clinical Research Prime
state: Idaho
city: Meridian
country: United States
facility: Velocity Clinical Research - Boise
state: Idaho
city: El Dorado
country: United States
facility: Alliance for Multispeciality Research, LLC
state: Kansas
city: Overland Park
country: United States
facility: Velocity Clinical Research-Kansas City
state: Kansas
city: Lafayette
country: United States
facility: Velocity Clinical Research - Lafayette
state: Louisiana
city: Metairie
country: United States
facility: Velocity Clinical Research Metairie
state: Louisiana
city: Southfield
country: United States
facility: Great Lakes Research Institute
state: Michigan
city: Southgate
country: United States
facility: Pediatric &amp; Adolescent Center
state: Michigan
city: Minneapolis
country: United States
facility: Clinical Research Institute
state: Minnesota
city: Gulfport
country: United States
facility: Velocity Clinical Research, Gulfport
state: Mississippi
city: Albuquerque
country: United States
facility: Velocity Clinical Research- Albuquerque
state: New Mexico
city: Binghamton
country: United States
facility: Velocity Clinical Research-Binghamton
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center (URMC) - Golisano Children's Hospital (GCH)
state: New York
city: South Euclid
country: United States
facility: Senders Pediatrics
state: Ohio
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia - Pediatrics
state: Pennsylvania
city: Philadelphia
country: United States
facility: DM Clinical Research - Philadelphia
state: Pennsylvania
city: Providence
country: United States
facility: Velocity Clinical Research - Providence
state: Rhode Island
city: Charleston
country: United States
facility: Coastal Pediatric Research
state: South Carolina
city: Simpsonville
country: United States
facility: Tribe Clinical Research
state: South Carolina
city: Austin
country: United States
facility: Elligo Clinical Research Center
state: Texas
city: Beaumont
country: United States
facility: REX Clinical Trials, LLC
state: Texas
city: Conroe
country: United States
facility: Javara Inc (Conroe)
state: Texas
city: Houston
country: United States
facility: West Houston Clinical Research Service
state: Texas
city: Houston
country: United States
facility: DM Clinical Research - CyFair
state: Texas
city: Plano
country: United States
facility: Village Pediatrics
state: Texas
city: Stephenville
country: United States
facility: Javara Inc/Texas Health Care, PLLC d/b/a/ Privia Medical Group-North Texas
state: Texas
city: Victoria
country: United States
facility: Victoria Clinical Research Group
state: Texas
city: West Jordan
country: United States
facility: Velocity Clinical Research - Salt Lake City
state: Utah
city: Annandale
country: United States
facility: PI-Coor Clinical Research, LLC
state: Virginia
city: Richmond
country: United States
facility: Clinical Research Partners
state: Virginia
city: Richmond
country: United States
facility: National Clinical Research, Inc.
state: Virginia
city: Ciudad de Panamá
country: Panama
facility: CEVAXIN 24 de Diciembre
city: La Chorrera
country: Panama
facility: CEVAXIN Chorrera
city: Panamá
country: Panama
facility: CEVAXIN Avenida Mexico
Study officials:
References: