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En studie av mRNA-1345, en mRNA-vaksine rettet mot respiratorisk syncytialvirus, hos barn 2 til

27. juli 2026 oppdatert av: ModernaTX, Inc.

En fase 2, randomisert, observatørblind studie for å evaluere sikkerheten, reaktogenisiteten og immunogenisiteten til mRNA-1345, en mRNA-vaksine rettet mot respiratorisk syncytialvirus, hos barn 2 til

Formålet med studien er å evaluere sikkerheten, reaktogenisiteten og immunogenisiteten til mRNA-1345 hos barn i alderen 2 til <5 år og hos barn med høy risiko for respiratorisk syncytialvirus (RSV) sykdom 5 til <18 år. å informere om valget av dosenivå for neste fase av utviklingen (fase 3).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

349

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn

Tar imot friske frivillige

Ja

Beskrivelse

Viktige inkluderingskriterier:

Kohort 1:

  • 2 til <5 år, på det tidspunktet det informerte samtykket signeres.
  • Frisk eller med stabile kroniske tilstander som øker risikoen for RSV-sykdom, ifølge etterforskerens kliniske vurdering.

Kohort 2:

  • 5 til <18 år, på det tidspunktet det informerte samtykket signeres.
  • Deltakere med stabile kroniske lidelser øker risikoen for RSV-sykdom.
  • Kvinnelige deltakere i fertil alder kan bli registrert i studien hvis deltakeren: 1) har en negativ uringraviditetstest ved screening og på injeksjonsdagen (dag 1); 2) har praktisert tilstrekkelig prevensjon eller har avstått fra alle aktiviteter som kan føre til graviditet i 28 dager før dag 1; 3) har gått med på å fortsette med adekvat prevensjon i 90 dager etter injeksjon; og 4) ammer ikke for øyeblikket.

Nøkkelekskluderingskriterier:

  • Akutt syk eller feber (temperatur ≥38,0 °Celsius [100,4 °Fahrenheit]) innen 72 timer før eller ved screeningbesøket eller dag 1.
  • Historie om en diagnose eller tilstand som, etter etterforskerens vurdering, kan påvirke studievurderingen eller kompromittere deltakersikkerheten.
  • Har mottatt eller planlegger å motta en lisensiert eller autorisert vaksine ≤14 dager før studievaksineinjeksjonen (dag 1) eller planlegger å motta en lisensiert eller autorisert vaksine innen 14 dager etter studievaksineinjeksjonen.
  • Mottak av tidligere systemiske immunsuppressiva eller immunmodifiserende legemidler. Korte kurs (<7 dager) med orale kortikosteroider er tillatt hvis de gjennomføres minst 3 måneder før påmelding.
  • Mottak av RSV monoklonale antistoffer innen 6 måneder før registrering i studien.
  • Deltok i en intervensjonell klinisk studie innen 28 dager (6 måneder for en studie som vurderer et produkt som ikke er lisensiert i denne aldersgruppen) før dagen for påmelding eller planlegger å gjøre det mens du er registrert i denne studien.

Merk: Andre protokolldefinerte inkluderings- og eksklusjonskriterier kan gjelde.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Del A og del B: Kohort 1 (2 til <5 år)
Del A: Deltakere 2 til <5 år vil motta enten en enkelt intramuskulær (IM) injeksjon av mRNA-1345 eller placebo på dag 1. Del B: Deltakerne vil ha muligheten til å bli registrert på nytt til en 6-måneders sikkerhetsperiode - oppfølgingsperiode.
Biologisk: Placebo
0,9 % natriumklorid (normal saltvann) injeksjon
Biologisk: mRNA-1345
Steril væske for injeksjon
Eksperimentell: Del A: Kohort 2 (5 til <18 år)
Deltakere 5 til <18 år vil motta en enkelt IM-injeksjon av mRNA-1345 på dag 1.
Biologisk: mRNA-1345
Steril væske for injeksjon

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Part A (Cohorts 1 and 2): Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Part A (Cohort 1): Geometric Mean Titer (GMT) of Serum RSV Neutralizing Antibody
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

ModernaTX, Inc.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

24. oktober 2023

Primær fullføring (Faktiske)

27. juni 2025

Studiet fullført (Faktiske)

27. juni 2025

Datoer for studieregistrering

Først innsendt

18. oktober 2023

Først innsendt som oppfylte QC-kriteriene

18. oktober 2023

Først lagt ut (Faktiske)

24. oktober 2023

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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