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En studie av mRNA-1345, ett mRNA-vaccin riktat mot luftvägssyncytialvirus, hos barn 2 till

27 juli 2026 uppdaterad av: ModernaTX, Inc.

En fas 2, randomiserad, observatörsblind studie för att utvärdera säkerheten, reaktogeniciteten och immunogeniciteten hos mRNA-1345, ett mRNA-vaccin som riktar sig mot luftvägssyncytialvirus, hos barn 2 till

Syftet med studien är att utvärdera säkerheten, reaktogeniciteten och immunogeniciteten av mRNA-1345 hos barn i åldern 2 till <5 år och hos barn med hög risk för respiratoriskt syncytialvirus (RSV) sjukdom 5 till <18 år. för att informera dosnivåvalet för nästa utvecklingsfas (fas 3).

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

349

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Arizona
      • Phoenix, Arizona, Förenta staterna, 85006
        • Velocity Clinical Research, Phoenix
      • Scottsdale, Arizona, Förenta staterna, 85260
        • Headlands Research - Scottsdale
    • California
      • Banning, California, Förenta staterna, 92220
        • Velocity Clinical Research - Banning
      • Fullerton, California, Förenta staterna, 92835
        • ASCADA Research, LLC - Family Medicine
      • Long Beach, California, Förenta staterna, 90815
        • ARK Clinical Research
      • Rolling Hills Estates, California, Förenta staterna, 90274
        • Peninsula Research Associates (PRA)
    • Florida
      • Doral, Florida, Förenta staterna, 33122
        • D&H Doral Research Center, LLC
      • Kissimmee, Florida, Förenta staterna, 34741
        • Kissimmee Clinical Research
      • Largo, Florida, Förenta staterna, 33777
        • Accel Clinical
      • Miami, Florida, Förenta staterna, 33125
        • Med-Care Research
      • Orlando, Florida, Förenta staterna, 32829
        • Accel Research Sites - Nona Pediatric Center
      • Pensacola, Florida, Förenta staterna, 32501
        • Sec Clinical Research
      • Tamarac, Florida, Förenta staterna, 33321
        • D&H Tamarac Research Center
    • Georgia
      • Fayetteville, Georgia, Förenta staterna, 30214
        • Javara, Inc.
      • Macon, Georgia, Förenta staterna, 31210
        • Velocity Clinical Research-Primary Pediatrics, Macon
      • Savannah, Georgia, Förenta staterna, 31405
        • CenExel iResearch, LLC
    • Idaho
      • Idaho Falls, Idaho, Förenta staterna, 83404
        • Clinical Research Prime
      • Meridian, Idaho, Förenta staterna, 83642
        • Velocity Clinical Research - Boise
    • Kansas
      • El Dorado, Kansas, Förenta staterna, 67042
        • Alliance for Multispeciality Research, LLC
      • Overland Park, Kansas, Förenta staterna, 66210
        • Velocity Clinical Research-Kansas City
    • Louisiana
      • Lafayette, Louisiana, Förenta staterna, 70508
        • Velocity Clinical Research - Lafayette
      • Metairie, Louisiana, Förenta staterna, 70006
        • Velocity Clinical Research Metairie
    • Michigan
      • Southfield, Michigan, Förenta staterna, 48075
        • Great Lakes Research Institute
      • Southgate, Michigan, Förenta staterna, 48195-1896
        • Pediatric & Adolescent Center
    • Minnesota
      • Minneapolis, Minnesota, Förenta staterna, 55402
        • Clinical Research Institute
    • Mississippi
      • Gulfport, Mississippi, Förenta staterna, 39503
        • Velocity Clinical Research, Gulfport
    • New Mexico
      • Albuquerque, New Mexico, Förenta staterna, 87107
        • Velocity Clinical Research- Albuquerque
    • New York
      • Binghamton, New York, Förenta staterna, 13905
        • Velocity Clinical Research-Binghamton
      • Rochester, New York, Förenta staterna, 14620
        • University of Rochester Medical Center (URMC) - Golisano Children's Hospital (GCH)
    • Ohio
      • South Euclid, Ohio, Förenta staterna, 44121
        • Senders Pediatrics
    • Pennsylvania
      • Philadelphia, Pennsylvania, Förenta staterna, 19107
        • DM Clinical Research - Philadelphia
      • Philadelphia, Pennsylvania, Förenta staterna, 19104-4318
        • The Children's Hospital of Philadelphia - Pediatrics
    • Rhode Island
      • Providence, Rhode Island, Förenta staterna, 02886
        • Velocity Clinical Research - Providence
    • South Carolina
      • Charleston, South Carolina, Förenta staterna, 29414
        • Coastal Pediatric Research
      • Simpsonville, South Carolina, Förenta staterna, 29680
        • TRIBE Clinical Research
    • Texas
      • Austin, Texas, Förenta staterna, 78704
        • Elligo Clinical Research Center
      • Beaumont, Texas, Förenta staterna, 77701
        • REX Clinical Trials, LLC
      • Conroe, Texas, Förenta staterna, 77384
        • Javara Inc (Conroe)
      • Houston, Texas, Förenta staterna, 77055
        • West Houston Clinical Research Service
      • Houston, Texas, Förenta staterna, 77065
        • DM Clinical Research - CyFair
      • Plano, Texas, Förenta staterna, 75024
        • Village Pediatrics
      • Stephenville, Texas, Förenta staterna, 76401
        • Javara Inc/Texas Health Care, PLLC d/b/a/ Privia Medical Group-North Texas
      • Victoria, Texas, Förenta staterna, 77901
        • Victoria Clinical Research Group
    • Utah
      • West Jordan, Utah, Förenta staterna, 84088
        • Velocity Clinical Research - Salt Lake City
    • Virginia
      • Annandale, Virginia, Förenta staterna, 22003
        • PI-Coor Clinical Research, LLC
      • Richmond, Virginia, Förenta staterna, 23294
        • National Clinical Research, Inc.
      • Richmond, Virginia, Förenta staterna, 23226
        • Clinical Research Partners
  • Panama
      • La Chorrera, Panama, 07066
        • CEVAXIN Chorrera
      • Panama City, Panama, 07093
        • CEVAXIN Avenida Mexico
      • Panama City, Panama, 07114
        • CEVAXIN 24 de Diciembre

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn

Tar emot friska volontärer

Ja

Beskrivning

Viktiga inkluderingskriterier:

Kohort 1:

  • 2 till <5 år, vid den tidpunkt då det informerade samtycket undertecknas.
  • Friska eller med stabila kroniska tillstånd som ökar risken för RSV-sjukdom, enligt utredarens kliniska bedömning.

Kohort 2:

  • 5 till <18 år, vid den tidpunkt då det informerade samtycket undertecknas.
  • Deltagare med stabila kroniska tillstånd ökar risken för RSV-sjukdom.
  • Kvinnliga deltagare i fertil ålder kan inkluderas i studien om deltagaren: 1) har ett negativt uringraviditetstest vid screening och på injektionsdagen (dag 1); 2) har använt adekvat preventivmedel eller har avstått från alla aktiviteter som kan leda till graviditet i 28 dagar före dag 1; 3) har gått med på att fortsätta med adekvat preventivmedel under 90 dagar efter injektionen; och 4) ammar inte för närvarande.

Viktiga uteslutningskriterier:

  • Akut sjuk eller febrig (temperatur ≥38,0°Celsius [100,4°Fahrenheit]) inom 72 timmar före eller vid visningsbesöket eller dag 1.
  • Historik om en diagnos eller tillstånd som, enligt utredarens bedömning, kan påverka studiebedömningen eller äventyra deltagarnas säkerhet.
  • Har mottagit eller planerar att ta emot något licensierat eller godkänt vaccin ≤14 dagar före studievaccininjektionen (dag 1) eller planerar att få ett licensierat eller godkänt vaccin inom 14 dagar efter studievaccininjektionen.
  • Mottagande av tidigare systemiska immunsuppressiva medel eller immunmodifierande läkemedel. Korta kurser (<7 dagar) med orala kortikosteroider är tillåtna om de genomförs minst 3 månader före inskrivningen.
  • Mottagande av monoklonala RSV-antikroppar inom 6 månader före inskrivning i studien.
  • Deltog i en interventionell klinisk studie inom 28 dagar (6 månader för en studie som bedömer en produkt som inte är licensierad i denna åldersgrupp) före dagen för registreringen eller planerar att göra det medan den är inskriven i denna studie.

Obs: Andra protokolldefinierade inkluderings- och uteslutningskriterier kan gälla.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Del A och Del B: Kohort 1 (2 till <5 år)
Del A: Deltagare 2 till <5 år kommer att få antingen en enstaka intramuskulär (IM) injektion av mRNA-1345 eller placebo på dag 1. Del B: Deltagarna kommer att ha möjlighet att återregistreras till en 6-månaders säkerhet - uppföljningsperiod.
Biologisk: Placebo
0,9% natriumklorid (normal koksaltlösning) injektion
Biologisk: mRNA-1345
Steril vätska för injektion
Experimentell: Del A: Kohort 2 (5 till <18 år)
Deltagare 5 till <18 år kommer att få en enda IM-injektion av mRNA-1345 på dag 1.
Biologisk: mRNA-1345
Steril vätska för injektion

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Part A (Cohorts 1 and 2): Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Tidsram: Up to 7 days post-injection
Solicited ARs were collected in an electronic diary (eDiary). Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered adverse events (AEs). Investigator reviewed whether the solicited AR was also to be recorded as an AE. A summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Up to 7 days post-injection
Part A (Cohorts 1 and 2): Number of Participants With Unsolicited Adverse Events (AEs)
Tidsram: Up to 28 days post-injection
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time [PT]/partial thromboplastin time [PTT]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsened from baseline and was considered clinically significant in the medical and scientific judgment of the Investigator was recorded as an AE. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Up to 28 days post-injection
Part A (Cohorts 1 and 2): Number of Participants With Medically Attended AEs (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation
Tidsram: Day 1 through end of Part A (Month 6)
A MAAE was an AE that led to an unscheduled visit to a healthcare practitioner. An AESI was an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor are required. An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly/birth defect, or was an important medical event. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Day 1 through end of Part A (Month 6)
Part B (Cohort 1): Number of Participants With RSV-RTD, Respiratory Syncytial Virus- Lower Respiratory Tract Disease (RSV-LRTD), Severe RSV-LRTD, Very Severe RSV-LRTD and RSV Hospitalization Classified by Clinical Assessment Team (CAT)
Tidsram: Day 1 through end of Part B (Month 6)
RSV-RTD: Runny nose or blocked nose or cough and confirmed RSV infection. RSV-LRTD: Cough or difficulty breathing (Based on Investigator's observation; difficulty breathing included signs of wheezing, stridor, tachypnoea, chest in-drawing or subcostal or intercostal retractions) and peripheral oxygen saturation (SpO2) <95%, or respiratory rate (RR) increased and confirmed RSV infection. RSV Severe-LRTD: Meeting the definition of RSV-LRTD and SpO2 <93%, or lower chest wall in-drawing. RSV Very Severe LRTD: Meeting the definition of RSV-LRTD and SpO2 <90%, or failure to respond/unconscious. RSV Hospitalization: Confirmed RSV and hospitalized for acute medical condition.
Day 1 through end of Part B (Month 6)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Part A (Cohort 1): Geometric Mean Titer (GMT) of Serum RSV Neutralizing Antibody
Tidsram: Day 1, Day 29, and Month 6
Antibody values reported as below lower limit of quantification (LLOQ) were replaced by 0.5*LLOQ. Values greater than the upper limit of quantification (ULOQ) were replaced by the ULOQ. LLOQ was 13 international units (IU)/milliliter (mL) for RSV-A and 10 IU/mL for RSV-B. ULOQ was 259061 IU/mL for RSV-A and 112476 IU/mL for RSV-B. 95% confidence interval (CI) for geometric mean (GM) value was calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation.
Day 1, Day 29, and Month 6
Part A (Cohort 1): Geometric Mean Concentration (GMC) of Serum RSV Prefusion F (Pre-F) Binding Antibody
Tidsram: Day 1, Day 29, and Month 6
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values greater than ULOQ were replaced by the ULOQ. LLOQ was 35 arbitrary units (AU)/mL and ULOQ was 580553 AU/mL for RSV Pre-F immunoglobulin G (IgG) antibody. 95% CI for GM value was calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation.
Day 1, Day 29, and Month 6
Part A (Cohort 1): Geometric Mean Fold Rise (GMFR) of Post-baseline/Baseline Neutralizing Antibody Titers
Tidsram: Day 29 and Month 6
Antibody values reported as below lower LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 13 IU/mL for RSV-A and 10 IU/mL for RSV-B. ULOQ was 259061 IU/mL for RSV-A and 112476 IU/mL for RSV-B. 95% CI for GMFR (post-injection/baseline titers) was calculated based on the t-distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation.
Day 29 and Month 6
Part A (Cohort 1): GMFR of Post-baseline/Baseline Binding Antibody Concentrations
Tidsram: Day 29 and Month 6
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values greater than ULOQ were replaced by the ULOQ. LLOQ was 35 AU/mL and ULOQ was 580553 AU/mL for RSV Pre-F IgG antibody. 95% CI for GMFR (post-injection/baseline titers) was calculated based on the t-distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation.
Day 29 and Month 6
Part A (Cohort 1): Percentage of Participants With Seroresponse in RSV Neutralizing Antibody
Tidsram: Baseline to Day 29 and Month 6
Seroresponse was defined as a change from below the LLOQ to equal or above 4 * LLOQ, or at least a 4-fold increase if baseline was equal to or above the LLOQ.
Baseline to Day 29 and Month 6
Part A (Cohort 1): Percentage of Participants With Seroresponse in RSV Pre-F Binding Antibody
Tidsram: Baseline to Day 29 and Month 6
Seroresponse was defined as a change from below the LLOQ to equal or above 4 * LLOQ, or at least a 4-fold increase if baseline was equal to or above the LLOQ.
Baseline to Day 29 and Month 6
Part A (Cohort 2): GMT of Serum RSV Neutralizing Antibody
Tidsram: Day 1 and Day 29
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 13 IU/mL for RSV-A and 15 IU/mL for RSV-B. ULOQ was 259061 IU/mL for RSV-A and 162163 IU/mL for RSV-B. 95% CI for GM value was calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation.
Day 1 and Day 29
Part A (Cohort 2): GMC of Serum RSV Pre-F Binding Antibody
Tidsram: Day 1 and Day 29
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values greater than ULOQ were replaced by the ULOQ. LLOQ was 35 AU/mL and ULOQ was 580553 AU/mL for RSV Pre-F IgG antibody. 95% CI for GM value was calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation.
Day 1 and Day 29
Part A (Cohort 2): GMFR of Post-baseline/Baseline Neutralizing Antibody Titers
Tidsram: Day 29
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 13 IU/mL for RSV-A and 15 IU/mL for RSV-B. ULOQ was 259061 IU/mL for RSV-A and 162163 IU/mL for RSV-B. 95% CI for GMFR (post-injection/baseline titers) was calculated based on the t-distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation.
Day 29
Part A (Cohort 2): GMFR of Post-baseline/Baseline Binding Antibody Concentrations
Tidsram: Day 29
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values greater than ULOQ were replaced by the ULOQ. LLOQ was 35 AU/mL and ULOQ was 580553 AU/mL for RSV Pre-F IgG antibody. 95% CI for GMFR (post-injection/baseline titers) was calculated based on the t-distribution of the differences in the log-transformed values between analysis timepoint and baseline, then back transformed to the original scale for presentation.
Day 29
Part A (Cohort 2): Percentage of Participants With Seroresponse in RSV Neutralizing Antibody
Tidsram: Baseline to Day 29
Seroresponse was defined as a change from below the LLOQ to equal or above 4 * LLOQ, or at least a 4-fold increase if baseline was equal to or above the LLOQ.
Baseline to Day 29
Part A (Cohort 2): Percentage of Participants With Seroresponse in RSV Pre-F Binding Antibody
Tidsram: Baseline to Day 29
Seroresponse was defined as a change from below the LLOQ to equal or above 4 * LLOQ, or at least a 4-fold increase if baseline was equal to or above the LLOQ.
Baseline to Day 29
Part B (Cohort 1): Number of Participants With AESIs and SAEs
Tidsram: Day 1 through Part B EOS (Month 6)
An AESI was an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor are required. An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly/birth defect, or was an important medical event. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Day 1 through Part B EOS (Month 6)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

ModernaTX, Inc.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

24 oktober 2023

Primärt slutförande (Faktisk)

27 juni 2025

Avslutad studie (Faktisk)

27 juni 2025

Studieregistreringsdatum

Först inskickad

18 oktober 2023

Först inskickad som uppfyllde QC-kriterierna

18 oktober 2023

Första postat (Faktisk)

24 oktober 2023

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

18 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

27 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • mRNA-1345-P202
  • 2024-000502-15 (EudraCT-nummer)

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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