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Eine Studie zur Bewertung der Sicherheit und Immunogenität von mRNA-1975 und mRNA-1982 gegen Lyme-Borreliose bei Teilnehmern im Alter von 18 bis 70 Jahren

6. Juli 2026 aktualisiert von: ModernaTX, Inc.

Eine randomisierte, beobachterblinde, placebokontrollierte, dosisabhängige Phase-1/2-Studie zur Bewertung der Sicherheit und Immunogenität von heptavalenter mRNA-1975 (SR1-7) und monovalenter mRNA-1982 (SR1) parallel gegen Lyme-Borreliose in Gesunde Teilnehmer im Alter von 18 bis 70 Jahren

Der Zweck dieser Studie besteht darin, die Sicherheit und Immunogenität parallel zu siebenwertiger mRNA-1975 und monovalenter mRNA-1982 gegen Lyme-Borreliose bei gesunden erwachsenen Teilnehmern zu bewerten.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

807

Phase

  • Phase 2
  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Connecticut
      • Milford, Connecticut, Vereinigte Staaten, 06460
        • Clinical Research Consulting, LLC
      • Stamford, Connecticut, Vereinigte Staaten, 06905
        • Stamford Therapeutics Consortium
      • Waterbury, Connecticut, Vereinigte Staaten, 06708
        • Chase Medical Research, LLC
    • Florida
      • Jacksonville, Florida, Vereinigte Staaten, 32216
        • Encore Research Group-Jacksonville Center for Clinical Research
      • Lake Mary, Florida, Vereinigte Staaten, 32746
        • University Clinical Research-DeLand, LLC d/b/a Accel Research Sites
    • Georgia
      • Stockbridge, Georgia, Vereinigte Staaten, 30281
        • Clinical Research Atlanta, headlands LLC
    • Kansas
      • Lenexa, Kansas, Vereinigte Staaten, 66219
        • Johnson County Clin-Trials, Inc. (JCCT)
    • Maryland
      • Columbia, Maryland, Vereinigte Staaten, 21045
        • Centennial Medical Group
      • Rockville, Maryland, Vereinigte Staaten, 20850
        • Advanced Primary and Geriatric Care
    • Massachusetts
      • Brookline, Massachusetts, Vereinigte Staaten, 02445
        • DM Clinical Research - Brookline
    • Minnesota
      • Minneapolis, Minnesota, Vereinigte Staaten, 55402
        • Clinical Research Institute, Inc.
    • Nebraska
      • Omaha, Nebraska, Vereinigte Staaten, 68134
        • Meridian Clinical Research - Omaha
    • New Hampshire
      • Newington, New Hampshire, Vereinigte Staaten, 03801
        • ActivMed Research LLC
    • New York
      • Rochester, New York, Vereinigte Staaten, 14609
        • Rochester Clinical Research, Inc.
    • Oklahoma
      • Oklahoma City, Oklahoma, Vereinigte Staaten, 73112
        • Lynn Health Science Institute
    • Pennsylvania
      • Hatboro, Pennsylvania, Vereinigte Staaten, 19040
        • Hatboro Medical Associates/CCT Research
    • Rhode Island
      • Providence, Rhode Island, Vereinigte Staaten, 02886
        • Velocity Clinical Research Providence
    • Texas
      • Fort Worth, Texas, Vereinigte Staaten, 76135
        • Benchmark Research
      • Tomball, Texas, Vereinigte Staaten, 77375
        • DM Clinical Research
    • Virginia
      • Charlottesville, Virginia, Vereinigte Staaten, 22911
        • Charlottesville Medical Research Center, LLC

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

Einschlusskriterien:

  • Body-Mass-Index von 18 bis 39 Kilogramm/Quadratmeter (einschließlich) beim Screening-Besuch.
  • Teilnehmer im nicht gebärfähigen Alter können in die Studie aufgenommen werden.
  • Für weibliche Teilnehmer im gebärfähigen Alter: negativer Schwangerschaftstest, angemessene Empfängnisverhütung oder Verzicht auf alle Aktivitäten, die während des Studieninterventionszeitraums zu einer Schwangerschaft führen könnten, und Zustimmung zur Aufrechterhaltung einer angemessenen Empfängnisverhütung oder Abstinenz bis zu 3 Monate nach der letzten Studieninjektion.

Ausschlusskriterien:

  • Sie haben eine chronische Krankheit im Zusammenhang mit der Lyme-Borreliose oder eine aktive symptomatische Lyme-Borreliose-Infektion, wie von einem Arzt vermutet oder diagnostiziert.
  • Wurde innerhalb der letzten 3 Monate wegen Lyme-Borreliose behandelt.
  • Hatte zuvor eine Impfung gegen Lyme-Borreliose oder nahm in der Vergangenheit an einer Impfstudie gegen Lyme-Borreliose teil.
  • Hatte innerhalb von 4 Wochen vor dem Studienbesuch einen Zeckenstich.
  • Dermatologische Erkrankungen, die sich auf örtlich erforderliche AR-Beurteilungen auswirken könnten (z. B. Tätowierungen; Psoriasis-Flecken, die die Haut über den Deltamuskelbereichen betreffen).
  • Sie haben innerhalb von 180 Tagen vor dem Screening-Besuch insgesamt mehr als 14 Tage lang systemische Immunsuppressiva erhalten (für Kortikosteroide ≥ 10 Milligramm/Tag Prednison oder Äquivalent) oder rechnet zu irgendeinem Zeitpunkt während der Teilnahme an der Studie mit der Notwendigkeit einer systemischen immunsuppressiven Behandlung.
  • Vorgeschichte von Myokarditis, Perikarditis oder Myoperikarditis, unabhängig vom Zeitpunkt der Vorgeschichte.
  • Vorgeschichte von Anaphylaxie, Urtikaria oder anderen erheblichen Nebenwirkungen, die einen medizinischen Eingriff erfordern, nach Erhalt eines Impfstoffs oder einer Intervention, die einen oder mehrere der gleichen Bestandteile enthält, die in der Studieninjektion enthalten sind.
  • Hat innerhalb von 90 Tagen vor dem Screening-Besuch systemische Immunglobuline, langwirksame biologische Therapien, die die Immunantwort beeinflussen (z. B. Infliximab), oder Blutprodukte erhalten oder plant, diese während der Studie zu erhalten.

Hinweis: Möglicherweise gelten andere Einschluss- und Ausschlusskriterien.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: mRNA-1975: Dosis 1
Die Teilnehmer erhalten an den Tagen 1, 57 und 169 drei intramuskuläre (IM) Injektionen des mRNA-1975-Impfstoffs mit Dosisstufe 1.
Biologisch: mRNA-1975
Dispersion lieferte IM
Andere Namen:
  • SR1-7
Experimental: mRNA-1975: Dosis 2
Die Teilnehmer erhalten an den Tagen 1, 57 und 169 drei IM-Injektionen des mRNA-1975-Impfstoffs mit Dosisstufe 2.
Biologisch: mRNA-1975
Dispersion lieferte IM
Andere Namen:
  • SR1-7
Experimental: mRNA-1975: Dosis 3
Die Teilnehmer erhalten an den Tagen 1, 57 und 169 drei IM-Injektionen des mRNA-1975-Impfstoffs mit Dosisstufe 3.
Biologisch: mRNA-1975
Dispersion lieferte IM
Andere Namen:
  • SR1-7
Experimental: mRNA-1975: Dosis 4
Die Teilnehmer erhalten an den Tagen 1, 57 und 169 drei IM-Injektionen des mRNA-1975-Impfstoffs mit Dosisstufe 4.
Biologisch: mRNA-1975
Dispersion lieferte IM
Andere Namen:
  • SR1-7
Experimental: mRNA-1982: Dosis 1
Die Teilnehmer erhalten an den Tagen 1, 57 und 169 drei IM-Injektionen des mRNA-1982-Impfstoffs mit Dosisstufe 1.
Biologisch: mRNA-1982
Dispersion lieferte IM
Andere Namen:
  • SR1
Experimental: mRNA-1982: Dosis 2
Die Teilnehmer erhalten an den Tagen 1, 57 und 169 drei IM-Injektionen des mRNA-1982-Impfstoffs mit Dosisstufe 2.
Biologisch: mRNA-1982
Dispersion lieferte IM
Andere Namen:
  • SR1
Experimental: mRNA-1982: Dosis 3
Die Teilnehmer erhalten an den Tagen 1, 57 und 169 drei IM-Injektionen des mRNA-1982-Impfstoffs mit Dosisstufe 3.
Biologisch: mRNA-1982
Dispersion lieferte IM
Andere Namen:
  • SR1
Placebo-Komparator: Placebo
Die Teilnehmer erhalten an den Tagen 1, 57 und 169 drei IM-Injektionen eines zum Impfstoff passenden Placebos.
Biologisch: Placebo
Lösung per Sofortnachricht geliefert

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) Within 7 Days After Day 1 Injection
Zeitfenster: Up to 7 days after Day 1 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 after Day 1 injection
Number of Participants With Solicited Local and Systemic ARs Within 7 Days After Day 57 Injection
Zeitfenster: Up to 7 days after Day 57 injection
Solicited ARs were collected in an 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 AEs. Investigator reviewed whether the solicited AR was also to be recorded as an AE. A summary of SAEs and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Up to 7 days after Day 57 injection
Number of Participants With Solicited Local and Systemic ARs Within 7 Days After Day 169 Injection
Zeitfenster: Up to 7 days after Day 169 injection
Solicited ARs were collected in an 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 AEs. Investigator reviewed whether the solicited AR was also to be recorded as an AE. A summary of SAEs and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Up to 7 days after Day 169 injection
Number of Participants With Unsolicited AEs
Zeitfenster: Up to 28 days post any 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 any injection
Number of Participants With Medically Attended AEs (MAAEs), Adverse Events of Special Interest (AESIs), SAEs, and AEs Leading to Study Discontinuation
Zeitfenster: Day 1 up to Month 18
A MAAE is an AE that led to an unscheduled visit to a healthcare practitioner. 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. 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 were required. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Day 1 up to Month 18

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Geometric Mean Concentration (GMC) of Anti-Outer Surface Protein (Anti-OspA) Binding Immunoglobulin (IgG) Antibodies for Serotype (SR-1) Antigen Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Zeitfenster: Days 1, 29, 85 and 197
Antibody values reported as below lower limit of quantification (LLOQ) were replaced by 0.5*LLOQ. Values reported greater than upper limit of quantification (ULOQ) were replaced by the ULOQ. LLOQ was 41.4 nanograms (ng)/milliliter (mL) and ULOQ was 428000 ng/mL for manual assay; LLOQ was 47.6 ng/mL and 583000 ng/mL for automated assay for SR-1 IgG antibody. 95% confidence interval (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.
Days 1, 29, 85 and 197
GMC of Anti-OspA Binding IgG Antibodies for SR-2 Antigen Measured by ELISA
Zeitfenster: Days 1, 29, 85, and 197
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values reported greater than ULOQ were replaced by the ULOQ. LLOQ was 30 ng/mL and ULOQ was 214000 ng/mL for manual assay; LLOQ was 66.6 ng/mL and 215000 ng/mL for automated assay for SR-2 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. Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
Days 1, 29, 85, and 197
GMC of Anti-OspA Binding IgG Antibodies for SR-3 Antigen Measured by ELISA
Zeitfenster: Days 1, 29, 85 and 197
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values reported greater than ULOQ were replaced by the ULOQ. LLOQ was 14.5 ng/mL and ULOQ was 299000 ng/mL for manual assay; LLOQ was 62.5 ng/mL and 296000 ng/mL for automated assay for SR-3 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. Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
Days 1, 29, 85 and 197
GMC of Anti-OspA Binding IgG Antibodies for SR-4 Antigen Measured by ELISA
Zeitfenster: Days 1, 29, 85 and 197
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values reported greater than ULOQ were replaced by the ULOQ. LLOQ was 32.6 ng/mL and ULOQ was 292000 ng/mL for manual assay; LLOQ was 59.7 ng/mL and 264000 ng/mL for automated assay for SR-4 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. Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
Days 1, 29, 85 and 197
GMC of Anti-OspA Binding IgG Antibodies for SR-5 Antigen Measured by ELISA
Zeitfenster: Days 1, 29, 85 and 197
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values reported greater than ULOQ were replaced by the ULOQ. LLOQ was 45.5 ng/mL and ULOQ was 298000 ng/mL for manual assay; LLOQ was 84.2 ng/mL and 319000 ng/mL for automated assay for SR-5 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. Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
Days 1, 29, 85 and 197
GMC of Anti-OspA Binding IgG Antibodies for SR-6 Antigen Measured by ELISA
Zeitfenster: Days 1, 29, 85 and 197
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values reported greater than ULOQ were replaced by the ULOQ. LLOQ was 18.1 ng/mL and ULOQ was 203000 ng/mL for manual assay; LLOQ was 68.7 ng/mL and 248000 ng/mL for automated assay for SR-6 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. Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
Days 1, 29, 85 and 197
GMC of Anti-OspA Binding IgG Antibodies for SR-7 Antigen Measured by ELISA
Zeitfenster: Days 1, 29, 85 and 197
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values reported greater than ULOQ were replaced by the ULOQ. LLOQ was 13 ng/mL and ULOQ was 197000 ng/mL for manual assay; LLOQ was 78.9 ng/mL and 174000 ng/mL for automated assay for SR-7 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. Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
Days 1, 29, 85 and 197
Geometric Mean Fold Rise (GMFR) of Anti-OspA Binding IgG Antibody Concentration for SR-1 Antigen
Zeitfenster: Days 29, 85 and 197
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values reported greater than ULOQ were replaced by the ULOQ. LLOQ was 41.4 ng/mL and ULOQ was 428000 ng/mL for manual assay; LLOQ was 47.6 ng/mL and 583000 ng/mL for automated assay for SR-1 IgG antibody. 95% CI for GMFR value was calculated based on the t-distribution of the difference in the log-transformed values, then back transformed to the original scale for presentation.
Days 29, 85 and 197
GMFR of Anti-OspA Binding IgG Antibody Concentration for SR-2 Antigen
Zeitfenster: Days 29, 85 and 197
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values reported greater than ULOQ were replaced by the ULOQ. LLOQ was 30 ng/mL and ULOQ was 214000 ng/mL for manual assay; LLOQ was 66.6 ng/mL and 215000 ng/mL for automated assay for SR-2 IgG antibody. 95% CI for GMFR value was calculated based on the t-distribution of the difference in the log-transformed values, then back transformed to the original scale for presentation. Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
Days 29, 85 and 197
GMFR of Anti-OspA Binding IgG Antibody Concentration for SR-3 Antigen
Zeitfenster: Days 29, 85 and 197
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values reported greater than ULOQ were replaced by the ULOQ. LLOQ was 14.5 ng/mL and ULOQ was 299000 ng/mL for manual assay; LLOQ was 62.5 ng/mL and 296000 ng/mL for automated assay for SR-3 IgG antibody. 95% CI for GMFR value was calculated based on the t-distribution of the difference in the log-transformed values, then back transformed to the original scale for presentation. Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
Days 29, 85 and 197
GMFR of Anti-OspA Binding IgG Antibody Concentration for SR-4 Antigen
Zeitfenster: Days 29, 85 and 197
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values reported greater than ULOQ were replaced by the ULOQ. LLOQ was 32.6 ng/mL and ULOQ was 292000 ng/mL for manual assay; LLOQ was 59.7 ng/mL and 264000 ng/mL for automated assay for SR-4 IgG antibody. 95% CI for GMFR value was calculated based on the t-distribution of the difference in the log-transformed values, then back transformed to the original scale for presentation. Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
Days 29, 85 and 197
GMFR of Anti-OspA Binding IgG Antibody Concentration for SR-5 Antigen
Zeitfenster: Days 29, 85 and 197
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values reported greater than ULOQ were replaced by the ULOQ. LLOQ was 45.5 ng/mL and ULOQ was 298000 ng/mL for manual assay; LLOQ was 84.2 ng/mL and 319000 ng/mL for automated assay for SR-5 IgG antibody. 95% CI for GMFR value was calculated based on the t-distribution of the difference in the log-transformed values, then back transformed to the original scale for presentation. Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
Days 29, 85 and 197
GMFR of Anti-OspA Binding IgG Antibody Concentration for SR-6 Antigen
Zeitfenster: Days 29, 85 and 197
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values reported greater than ULOQ were replaced by the ULOQ. LLOQ was 18.1 ng/mL and ULOQ was 203000 ng/mL for manual assay; LLOQ was 68.7 ng/mL and 248000 ng/mL for automated assay for SR-6 IgG antibody. 95% CI for GMFR value was calculated based on the t-distribution of the difference in the log-transformed values, then back transformed to the original scale for presentation. Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
Days 29, 85 and 197
GMFR of Anti-OspA Binding IgG Antibody Concentration for SR-7 Antigen
Zeitfenster: Days 29, 85 and 197
Antibody values reported as below LLOQ were replaced by 0.5*LLOQ. Values reported greater than ULOQ were replaced by the ULOQ. LLOQ was 13 ng/mL and ULOQ was 197000 ng/mL for manual assay; LLOQ was 78.9 ng/mL and 174000 ng/mL for automated assay for SR-7 IgG antibody. 95% CI for GMFR value was calculated based on the t-distribution of the difference in the log-transformed values, then back transformed to the original scale for presentation. Since mRNA-1982 was designed to elicit antibodies against SR-1 antigen only, the data for this outcome measure has been reported for mRNA-1975 and placebo arms only.
Days 29, 85 and 197

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Deaths Related to Study Drug
Zeitfenster: Day 1 up to Month 18
A death that occurred during the study or that came to the attention of the investigator during the study was reported to the Sponsor, whether or not it was considered related to study drug. The investigator assessed causality (that is, whether there is a reasonable possibility that the study drug caused the death). The relationship was characterized using the following classifications: Not related: There was not a reasonable possibility of a relationship to the study drug. The temporal sequence of the death relative to administration of the study drug was not reasonable AND/OR the death was more likely explained by a cause other than the study drug. Related: There was a reasonable possibility of a relationship to the study drug. There was evidence of exposure to the study drug. The temporal sequence of the death relative to the administration of the study drug was reasonable. The death was more likely explained by the study drug than by another cause.
Day 1 up to Month 18

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

ModernaTX, Inc.

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

26. Juli 2023

Primärer Abschluss (Tatsächlich)

30. Mai 2025

Studienabschluss (Tatsächlich)

30. Mai 2025

Studienanmeldedaten

Zuerst eingereicht

26. Juli 2023

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

26. Juli 2023

Zuerst gepostet (Tatsächlich)

3. August 2023

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

30. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

6. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • mRNA-1975/1982-P101

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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