Respiratory Syncytial Virus Clinical Trial
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
Verified date | February 2024 |
Source | ModernaTX, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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. |
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&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 & 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 |
Lead Sponsor | Collaborator |
---|---|
ModernaTX, Inc. |
United States, Panama,
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 |
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