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

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

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
• 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
• 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.

Related Conditions & MeSH terms

• Respiratory Syncytial Virus
• Virus Diseases

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&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

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