Back to resultsA 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
Primary Purpose
Respiratory Syncytial Virus
Status
Not yet recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
mRNA-1345
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Respiratory Syncytial Virus focused on measuring mRNA-1345, RSV vaccine, Viral Diseases, Messenger RNA, Moderna
Eligibility Criteria
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.
Sites / Locations
- Velocity Clinical Research - Banning
- Med-Care Research
- Accel Research Sites - Nona Pediatric Center
- Accel Clinical
- Elite Clinical Trials
- Velocity Clinical Research - Boise
- Velocity Clinical Research
- Velocity Clinical Research Metairie
- Velocity Clinical Research- Albuquerque
- Velocity Clinical Research-Binghamton
- Wellnow Urgent Care & Research
- DM Clinical Research - Philadelphia
- Velocity Clinical Research - Providence
- Coastal Pediatric Research
- West Houston Clinical Research Service
- DM Clinical Research - CyFair
- Victoria Clinical Research Group
- Clinical Research Partners
- CEVAXIN Avenida Mexico
- CEVAXIN 24 de Diciembre
- CEVAXIN Chorrera
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cohort 1 (2 to <5 Years of Age)
Cohort 2 (5 to <18 Years of Age)
Arm Description
Participants 2 to <5 years of age will receive either a single intramuscular (IM) injection of mRNA-1345 or placebo on Day 1.
Participants 5 to <18 years of age will receive either a single IM injection of mRNA-1345 or placebo on Day 1.
Outcomes
Primary Outcome Measures
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Number of Participants with Unsolicited Adverse Events (AEs)
Number of Participants With Medically Attended AEs (MAAEs)
Number of Participants With Adverse Events of Special Interest (AESIs)
Number of Participants With Serious Adverse Events (SAEs)
Number of Participants With AEs Leading to Discontinuation
Secondary Outcome Measures
Geometric Mean Titer (GMT) of Serum RSV Neutralizing Antibody
Geometric Mean Concentration (GMC) of Serum RSV Prefusion F Binding Antibody
Geometric Mean Fold Rise (GMFR) of Postbaseline/Baseline Neutralizing Antibody Titers and Binding Antibody Concentrations
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06097299
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 23, 2023 (Anticipated)
Primary Completion Date
January 12, 2024 (Anticipated)
Study Completion Date
July 19, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ModernaTX, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Syncytial Virus
Keywords
mRNA-1345, RSV vaccine, Viral Diseases, Messenger RNA, Moderna
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
340 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1 (2 to <5 Years of Age)
Arm Type
Experimental
Arm Description
Participants 2 to <5 years of age will receive either a single intramuscular (IM) injection of mRNA-1345 or placebo on Day 1.
Arm Title
Cohort 2 (5 to <18 Years of Age)
Arm Type
Experimental
Arm Description
Participants 5 to <18 years of age will receive either a single IM injection of mRNA-1345 or placebo on Day 1.
Intervention Type
Biological
Intervention Name(s)
mRNA-1345
Intervention Description
Sterile liquid for injection
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
0.9% sodium chloride (normal saline) injection
Primary Outcome Measure Information:
Title
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Time Frame
Up to 7 days postinjection
Title
Number of Participants with Unsolicited Adverse Events (AEs)
Time Frame
Up to 28 days postinjection
Title
Number of Participants With Medically Attended AEs (MAAEs)
Time Frame
Day 1 through end of study (EOS; Month 6)
Title
Number of Participants With Adverse Events of Special Interest (AESIs)
Time Frame
Day 1 through EOS (Month 6)
Title
Number of Participants With Serious Adverse Events (SAEs)
Time Frame
Day 1 through EOS (Month 6)
Title
Number of Participants With AEs Leading to Discontinuation
Time Frame
Day 1 through EOS (Month 6)
Secondary Outcome Measure Information:
Title
Geometric Mean Titer (GMT) of Serum RSV Neutralizing Antibody
Time Frame
Day 1, Day 29, and Month 6
Title
Geometric Mean Concentration (GMC) of Serum RSV Prefusion F Binding Antibody
Time Frame
Day 1, Day 29, and Month 6
Title
Geometric Mean Fold Rise (GMFR) of Postbaseline/Baseline Neutralizing Antibody Titers and Binding Antibody Concentrations
Time Frame
Baseline to Day 29 and Month 6
Title
Number of Participants With Seroresponse in RSV Neutralizing Antibody
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Moderna Clinical Trials Support Center
Phone
1-877-777-7187
Email
clinicaltrials@modernatx.com
Facility Information:
Facility Name
Velocity Clinical Research - Banning
City
Banning
State/Province
California
ZIP/Postal Code
92220
Country
United States
Facility Name
Med-Care Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Accel Research Sites - Nona Pediatric Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32829
Country
United States
Facility Name
Accel Clinical
City
Seminole
State/Province
Florida
ZIP/Postal Code
33777
Country
United States
Facility Name
Elite Clinical Trials
City
Blackfoot
State/Province
Idaho
ZIP/Postal Code
83221
Country
United States
Facility Name
Velocity Clinical Research - Boise
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Velocity Clinical Research
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70508
Country
United States
Facility Name
Velocity Clinical Research Metairie
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Velocity Clinical Research- Albuquerque
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87107
Country
United States
Facility Name
Velocity Clinical Research-Binghamton
City
Binghamton
State/Province
New York
ZIP/Postal Code
13905
Country
United States
Facility Name
Wellnow Urgent Care & Research
City
Huber Heights
State/Province
Ohio
ZIP/Postal Code
45424
Country
United States
Facility Name
DM Clinical Research - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Velocity Clinical Research - Providence
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Coastal Pediatric Research
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
West Houston Clinical Research Service
City
Houston
State/Province
Texas
ZIP/Postal Code
77055
Country
United States
Facility Name
DM Clinical Research - CyFair
City
Houston
State/Province
Texas
ZIP/Postal Code
77065
Country
United States
Facility Name
Victoria Clinical Research Group
City
Victoria
State/Province
Texas
ZIP/Postal Code
77901
Country
United States
Facility Name
Clinical Research Partners
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23223
Country
United States
Facility Name
CEVAXIN Avenida Mexico
City
Caledonia
ZIP/Postal Code
07093
Country
Panama
Facility Name
CEVAXIN 24 de Diciembre
City
Ciudad de Panamá
ZIP/Postal Code
07114
Country
Panama
Facility Name
CEVAXIN Chorrera
City
La Chorrera
ZIP/Postal Code
07066
Country
Panama
12. IPD Sharing Statement
Learn more about this trial
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
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