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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06097299
Other study ID # mRNA-1345-P202
Secondary ID 2023-506271-96-0
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date October 24, 2023
Est. completion date July 19, 2024

Study information

Verified date February 2024
Source ModernaTX, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1345 in children aged 2 to <5 years of age and in children at high risk of respiratory syncytial virus (RSV) disease 5 to <18 years of age to inform the dose level selection for the next phase of development (Phase 3).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 340
Est. completion date July 19, 2024
Est. primary completion date July 19, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years to 17 Years
Eligibility Key Inclusion Criteria: Cohort 1: - 2 to <5 years of age, at the time the informed consent is signed. - 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 the time the informed consent is signed. - 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. Key Exclusion Criteria: - 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 or immune-modifying drugs. 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 in this age group) prior to the day of enrollment or plans to do so while enrolled in this study. Note: Other protocol-defined inclusion and exclusion criteria may apply.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
mRNA-1345
Sterile liquid for injection
Placebo
0.9% sodium chloride (normal saline) injection

Locations

Country Name City State
Panama CEVAXIN 24 de Diciembre Ciudad de Panamá
Panama CEVAXIN Chorrera La Chorrera
Panama CEVAXIN Avenida Mexico Panamá
United States Velocity Clinical Research- Albuquerque Albuquerque New Mexico
United States PI-Coor Clinical Research, LLC Annandale Virginia
United States Elligo Clinical Research Center Austin Texas
United States Velocity Clinical Research - Banning Banning California
United States REX Clinical Trials, LLC Beaumont Texas
United States Velocity Clinical Research-Binghamton Binghamton New York
United States Coastal Pediatric Research Charleston South Carolina
United States Javara Inc (Conroe) Conroe Texas
United States D&amp;H Doral Research Center, LLC Doral Florida
United States Alliance for Multispeciality Research, LLC El Dorado Kansas
United States Javara, Inc. Fayetteville Georgia
United States ASCADA Research, LLC - Family Medicine Fullerton California
United States Velocity Clinical Research, Gulfport Gulfport Mississippi
United States DM Clinical Research - CyFair Houston Texas
United States West Houston Clinical Research Service Houston Texas
United States Clinical Research Prime Idaho Falls Idaho
United States Kissimmee Clinical Research Kissimmee Florida
United States Velocity Clinical Research - Lafayette Lafayette Louisiana
United States Accel Clinical Largo Florida
United States Ark Clinical Research Long Beach California
United States Velocity Clinical Research-Primary Pediatrics, Macon Macon Georgia
United States Velocity Clinical Research - Boise Meridian Idaho
United States Velocity Clinical Research Metairie Metairie Louisiana
United States Med-Care Research Miami Florida
United States Clinical Research Institute Minneapolis Minnesota
United States Accel Research Sites - Nona Pediatric Center Orlando Florida
United States Velocity Clinical Research-Kansas City Overland Park Kansas
United States SEC Clinical Research Pensacola Florida
United States DM Clinical Research - Philadelphia Philadelphia Pennsylvania
United States The Children's Hospital of Philadelphia - Pediatrics Philadelphia Pennsylvania
United States Velocity Clinical Research, Phoenix Phoenix Arizona
United States Village Pediatrics Plano Texas
United States Velocity Clinical Research - Providence Providence Rhode Island
United States Clinical Research Partners Richmond Virginia
United States National Clinical Research, Inc. Richmond Virginia
United States University of Rochester Medical Center (URMC) - Golisano Children's Hospital (GCH) Rochester New York
United States Peninsula Research Associates (PRA) Rolling Hills Estates California
United States CenExel iResearch, LLC Savannah Georgia
United States Headlands Research - Scottsdale Scottsdale Arizona
United States Tribe Clinical Research Simpsonville South Carolina
United States Senders Pediatrics South Euclid Ohio
United States Great Lakes Research Institute Southfield Michigan
United States Pediatric &amp; Adolescent Center Southgate Michigan
United States Javara Inc/Texas Health Care, PLLC d/b/a/ Privia Medical Group-North Texas Stephenville Texas
United States D&H Tamarac Research Center Tamarac Florida
United States Victoria Clinical Research Group Victoria Texas
United States Velocity Clinical Research - Salt Lake City West Jordan Utah

Sponsors (1)

Lead Sponsor Collaborator
ModernaTX, Inc.

Countries where clinical trial is conducted

United States,  Panama, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) Up to 7 days postinjection
Primary Number of Participants with Unsolicited Adverse Events (AEs) Up to 28 days postinjection
Primary Number of Participants With Medically Attended AEs (MAAEs) Day 1 through end of study (EOS; Month 6)
Primary Number of Participants With Adverse Events of Special Interest (AESIs) Day 1 through EOS (Month 6)
Primary Number of Participants With Serious Adverse Events (SAEs) Day 1 through EOS (Month 6)
Primary Number of Participants With AEs Leading to Discontinuation Day 1 through EOS (Month 6)
Secondary Geometric Mean Titer (GMT) of Serum RSV Neutralizing Antibody Day 1, Day 29, and Month 6
Secondary Geometric Mean Concentration (GMC) of Serum RSV Prefusion F Binding Antibody Day 1, Day 29, and Month 6
Secondary Geometric Mean Fold Rise (GMFR) of Postbaseline/Baseline Neutralizing Antibody Titers and Binding Antibody Concentrations Baseline to Day 29 and Month 6
Secondary 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 Baseline to Day 29 and Month 6
See also
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