A Safety, Tolerability, and Immunogenicity Study of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 Months
- Conditions
- Respiratory Syncytial VirusHuman Metapneumovirus
- Interventions
- Registration Number
- NCT05743881
- Lead Sponsor
- ModernaTX, Inc.
- Brief Summary
The purpose of this study is to assess the safety and immunogenicity of mRNA-1365, an mRNA vaccine targeting respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) and mRNA-1345, an mRNA vaccine targeting RSV, in participants aged 5 months to \<24 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 310
- The participant is 8 months to <24 months (Part A), 5 months to <8 months (Part B), or 8 months to <12 months (Part C) of age at the time of randomization (Day 1/Baseline visit), who is in good general health, in the opinion of the Investigator, based on review of medical history and screening physical examination.
- In the Investigator's opinion, the parent(s)/ legally authorized representative (LAR)(s) understand and are willing and physically able to comply with protocol-mandated follow up, including all procedures, and provide written informed consent.
- The participant is growing normally for age in the opinion of the site clinician in the months prior to enrollment.
- The participant was born at full-term (≥37 weeks gestation) with a minimum birth weight of 2.5 kilograms (kg).
- For Part C Cohort 7: participant must have received nirsevimab ≥6 months prior to Day 1 Visit.
- For Part C Cohort 8: participant was eligible at any time since birth, according to national guidelines, to receive nirsevimab prior to Day 1 Visit but did not do so.
- Has a known history of symptomatic RSV (Part A: within 3 months; Part B and Part C: since birth) or hMPV infection (Part A: within 3 months; Part B: since birth) prior to administration of the first dose of investigational product (IP) or has a known close contact with anyone with laboratory-confirmed RSV (Parts A, B, and C) or hMPV infection (Parts A or B) within 14 days prior to administration of the first dose of IP.
- Is acutely ill or febrile 24 hours prior to or at the screening visit. Fever is defined as a body temperature ≥38.0°Celsius/≥100.4°Fahrenheit. Participants who meet this criterion may have visits rescheduled within the relevant study visit windows.
- Has previously been administered an investigational or approved vaccine for prevention of RSV (Parts A, B, and C) or hMPV (Parts A and B) infection or if the participant's mother received an investigational or approved vaccine for the prevention of RSV (Parts A, B, and C) or hMPV (Parts A and B) infection during pregnancy.
- Has received investigational or approved agents for prophylaxis against RSV or hMPV (for example, monoclonal antibodies) or is intending to receive these during the course of the study. For Part C (Cohort 7 only), use of nirsevimab ≥6 months before Day 1 Visit is allowed.
- Has a known hypersensitivity to a component of the vaccine or its excipients. Hypersensitivity includes, but is not limited to, anaphylaxis or immediate allergic reaction of any severity to a previous dose of an mRNA vaccine or any of its components (including polyethylene glycol or immediate allergic reaction of any severity to polysorbate).
- Has a medical condition that, according to the Investigator's judgment, may pose additional risk as a result of participation, interfere with safety assessments, or interfere with interpretation of results.
Note: Other protocol-defined inclusion/exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part A: Placebo (Age Group: 8 to <24 months) Nimenrix Participants will receive mRNA-1345/ mRNA-1365 vaccine matching placebo by IM injection on Days 1, 57 and 113. In countries where applicable, participants may receive Nimenrix instead of placebo on Day 113. Part B: Placebo (Age Group: 5 to <8 months) Nimenrix Participants will receive mRNA-1345/ mRNA-1365 vaccine matching placebo by IM injection on Days 1, 57 and 113. In countries where applicable, participants may receive Nimenrix instead of placebo on Day 113. Part B: mRNA-1345, Dose 2 (Age Group: 5 to <8 months) mRNA-1345 Participants will receive mRNA-1345 by IM injection on Days 1, 57 and 113. Part B: mRNA-1365, Dose 2 (Age Group: 5 to <8 months) mRNA-1365 Participants will receive mRNA-1365 by IM injection on Days 1, 57 and 113. Part A: mRNA-1345, Dose 1 (Age Group: 8 to <24 months) mRNA-1345 Participants will receive mRNA-1345 vaccine by intramuscular (IM) injection on Days 1, 57 and 113. Part A: Placebo (Age Group: 8 to <24 months) Placebo Participants will receive mRNA-1345/ mRNA-1365 vaccine matching placebo by IM injection on Days 1, 57 and 113. In countries where applicable, participants may receive Nimenrix instead of placebo on Day 113. Part A: mRNA-1365, Dose 1 (Age Group: 8 to <24 months) mRNA-1365 Participants will receive mRNA-1365 vaccine by IM injection on Days 1, 57 and 113. Part B: mRNA-1345 Dose 1 (Age Group: 5 to <8 months) mRNA-1345 Participants will receive mRNA-1345 by IM injection on Days 1, 57 and 113. Part C: mRNA-1345 Dose 1 (Age Group 8 to <12 months exposed to nirsevimab) mRNA-1345 Participants who have been previously exposed to nirsevimab will receive mRNA 1345 by IM on Days 1, 57, and 113. Part B: Placebo (Age Group: 5 to <8 months) Placebo Participants will receive mRNA-1345/ mRNA-1365 vaccine matching placebo by IM injection on Days 1, 57 and 113. In countries where applicable, participants may receive Nimenrix instead of placebo on Day 113. Part B: mRNA-1365 Dose 1 (Age Group: 5 to <8 months) mRNA-1365 Participants will receive mRNA-1365 by IM injection on Days 1, 57 and 113. Part C: mRNA-1345 Dose 1 (Age Group 8 to <12 months not exposed to nirsevimab) mRNA-1345 Participants who have not been previously exposed to nirsevimab will receive mRNA 1345 by IM on Days 1, 57, and 113.
- Primary Outcome Measures
Name Time Method Number of Participants with Medically-Attended Adverse Events (MAAEs) Day 1 through Day 730 Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) Up to Day 120 (7 days after each injection) Number of Participants with Unsolicited Adverse Events (AEs) Up to Day 141 (28 days after each injection) Number of Participants with Adverse Event of Special Interests (AESIs), Serious Adverse Events (SAEs) and Adverse Events Leading to Discontinuation Day 1 through Day 730
- Secondary Outcome Measures
Name Time Method Number of Participants with Respiratory Tract Illness (RTI), Lower Respiratory Tract Illness (LRTI), Severe LRTI, Very Severe LRTI, and Hospitalizations Associated with RSV or hMPV Day 1 through Day 730 Parts A and B: Geometric Mean Titer (GMT) of Serum RSV and hMPV Neutralizing Antibodies Baseline up to Month 12 Part C: GMT of Serum RSV Neutralizing Antibodies Baseline up to Month 12 Parts A and B: Geometric Mean Concentration (GMC) of Serum RSV F- and hMPV F-Binding Antibodies Baseline up to Month 12 Part C: GMC of Serum RSV F-Binding Antibodies Baseline up to Month 12 Geometric Mean Fold-Rise (GMFR) Postbaseline/baseline Neutralizing Antibody Titers Baseline up to Month 12 Number of Participants with Vaccine-specific T-cell Responses Measured by Flow Cytometry Baseline up to month 12
Trial Locations
- Locations (55)
Los Angeles Children's Hospital
🇺🇸Los Angeles, California, United States
Palmetto Pediatrics, PA
🇺🇸North Charleston, South Carolina, United States
Family Centre for Research with Ubuntu (FAMCRU)- Tygerberg
🇿🇦Cape Town, Western Cape, South Africa
CEVAXIN 24 de Diciembre
🇵🇦Ciudad de Panamá, Panama
Clinical Research Prime
🇺🇸Idaho Falls, Idaho, United States
CEVAXIN Chorrera
🇵🇦La Chorrera, Panama Oeste, Panama
Vanderbilt Vaccine Research Program
🇺🇸Nashville, Tennessee, United States
BC Children's Hospital - Vaccine Evaluation Centre - Neonatology
🇨🇦Vancouver, British Columbia, Canada
Universite de Montreal - Centre Hospitalier Universitaire (CHU) Sainte-Justine
🇨🇦Montreal, Quebec, Canada
Vistamed
🇵🇱Wroclaw, Dolnoslaskie, Poland
Centrum Medyczne Plejady
🇵🇱Krakow, Poland
Practice Dr Jan Vermeulen
🇿🇦Cape Town, Western Cape, South Africa
Szpital im. Sw. Jadwigi Slaskiej w Trzebnicy
🇵🇱Trzebnica, Dolnoslaskie, Poland
CyFair
🇺🇸Houston, Texas, United States
Pediatric Specialty Care Discovery Clinic
🇺🇸Minneapolis, Minnesota, United States
Hospital Universitario Arnau de Vilanova
🇪🇸Lleida, Spain
Velocity Clinical Research, Denver
🇺🇸Englewood, Colorado, United States
Matrix Clinical Research
🇺🇸Los Angeles, California, United States
Village Pediatrics
🇺🇸Plano, Texas, United States
University Of Florida Health Science Center
🇺🇸Jacksonville, Florida, United States
Meridian Clinical Research
🇺🇸Hastings, Nebraska, United States
Umass Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
Accel Research Sites - Nona Pediatric Center
🇺🇸Orlando, Florida, United States
MedPharmics - Platinum - PPDS
🇺🇸Lafayette, Louisiana, United States
UMASS Chan Medical School
🇺🇸Worcester, Massachusetts, United States
Washington University School of Medicine in St. Louis
🇺🇸Saint Louis, Missouri, United States
Great Lakes Research Institute
🇺🇸Southfield, Michigan, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Senders Pediatrics
🇺🇸South Euclid, Ohio, United States
Duke Vaccine and Trials Unit
🇺🇸Durham, North Carolina, United States
Velocity Clinical Research - Providence
🇺🇸Providence, Rhode Island, United States
Texas Tech University Health Sciences Center
🇺🇸El Paso, Texas, United States
Mercury Clinical Research, Inc.
🇺🇸Richmond, Texas, United States
Pediatric Associates
🇺🇸Houston, Texas, United States
Pediatric Center
🇺🇸Richmond, Texas, United States
Childrens Hospital Regional Medical Center
🇺🇸Seattle, Washington, United States
North Houston Internal Medicine & Pediatric Clinic
🇺🇸Tomball, Texas, United States
Telethon Kids Institute
🇦🇺Nedlands, Western Australia, Australia
Dalhousie University IWK Health Centre
🇨🇦Halifax, Nova Scotia, Canada
CEVAXIN David
🇵🇦David, Chiriquí, Panama
London Health Sciences Centre - Victoria Hospital
🇨🇦London, Ontario, Canada
CEVAXIN Avenida Mexico
🇵🇦Panama City, Panama
Centrum Badań Klinicznych JCI Jagiellońskie Centrum Innowacji Sp. z o.o.
🇵🇱Krakow, Malopolskie, Poland
Shandukani Research CRS
🇿🇦Hillbrow, Gauteng, South Africa
Wits Health Consortium
🇿🇦Johannesburg, Gauteng, South Africa
Setshaba Research centre
🇿🇦Soshanguve, Gauteng, South Africa
Complexo Hospitalario Universitario De Santiago
🇪🇸Santiago de Compostela, A Coruña, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Carlos III-Hospital Universitario La Paz
🇪🇸Madrid, Spain
Alder Hey NHS Foundation Trust - Pharmacy Clinical Trials
🇬🇧Liverpool, United Kingdom
St George's Hospital
🇬🇧London, United Kingdom
Imperial College London and Imperial College Healthcare NHS
🇬🇧London, United Kingdom
Norfolk and Norwich University Hospitals
🇬🇧Norwich, United Kingdom
John Radcliffe Hospital
🇬🇧Oxford, United Kingdom
Southampton General Hospital
🇬🇧Southampton, United Kingdom