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Uno studio per valutare la sicurezza e l'immunogenicità dell'mRNA-1975 e dell'mRNA-1982 contro la malattia di Lyme nei partecipanti di età compresa tra 18 e 70 anni

6 luglio 2026 aggiornato da: ModernaTX, Inc.

Uno studio di fase 1/2, randomizzato, in cieco per l'osservatore, controllato con placebo, a dosaggio variabile per valutare la sicurezza e l'immunogenicità dell'mRNA eptavalente-1975 (SR1-7) e dell'mRNA monovalente-1982 (SR1) in parallelo contro la malattia di Lyme in Partecipanti sani di età compresa tra 18 e 70 anni

Lo scopo di questo studio è valutare la sicurezza e l'immunogenicità in parallelo dell'mRNA-1975 eptavalente e dell'mRNA-1982 monovalente contro la malattia di Lyme in partecipanti adulti sani.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

807

Fase

  • Fase 2
  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Descrizione

Criterio di inclusione:

  • Indice di massa corporea da 18 a 39 chilogrammi/metro quadrato (inclusi) alla visita di screening.
  • I partecipanti potenzialmente non fertili possono essere arruolati nello studio.
  • Per le partecipanti di sesso femminile in età fertile: test di gravidanza negativo, contraccezione adeguata o astensione da tutte le attività che potrebbero portare a una gravidanza durante il periodo di intervento dello studio e accordo per continuare un'adeguata contraccezione o astinenza per 3 mesi dopo l'ultima iniezione dello studio.

Criteri di esclusione:

  • Avere una malattia cronica correlata alla malattia di Lyme o un'infezione sintomatica attiva della malattia di Lyme sospettata o diagnosticata da un medico.
  • Ricevuto trattamento per la malattia di Lyme nei 3 mesi precedenti.
  • Aveva una precedente vaccinazione contro la malattia di Lyme o ha partecipato in passato a qualsiasi studio sui vaccini per la malattia di Lyme.
  • - Ha avuto una puntura di zecca entro 4 settimane prima della visita di iniezione dello studio.
  • Condizioni dermatologiche che potrebbero influenzare le valutazioni AR sollecitate locali (ad esempio, tatuaggi; macchie di psoriasi che colpiscono la pelle sopra le aree deltoidi).
  • - Ha ricevuto immunosoppressori sistemici per> 14 giorni in totale entro 180 giorni prima della visita di screening (per corticosteroidi, ≥10 milligrammi/giorno di prednisone o equivalente) o prevede la necessità di un trattamento immunosoppressivo sistemico in qualsiasi momento durante la partecipazione allo studio.
  • Storia di miocardite, pericardite o miopericardite indipendentemente dai tempi della storia medica passata.
  • Storia di anafilassi, orticaria o altra reazione avversa significativa che richieda un intervento medico dopo aver ricevuto un vaccino o un intervento che includa uno o più degli stessi componenti contenuti nell'iniezione dello studio.
  • - Ha ricevuto immunoglobuline sistemiche, terapie biologiche a lunga durata d'azione che influenzano le risposte immunitarie (ad esempio, infliximab) o prodotti sanguigni entro 90 giorni prima della visita di screening o prevede di riceverli durante lo studio.

Nota: potrebbero essere applicati altri criteri di inclusione ed esclusione.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: mRNA-1975: Dose 1
I partecipanti riceveranno 3 iniezioni intramuscolari (IM) del vaccino mRNA-1975 al livello di dose 1 nei giorni 1, 57 e 169.
Biologico: mRNA-1975
Dispersione consegnata IM
Altri nomi:
  • RS1-7
Sperimentale: mRNA-1975: Dose 2
I partecipanti riceveranno 3 iniezioni IM del vaccino mRNA-1975 al livello di dose 2 nei giorni 1, 57 e 169.
Biologico: mRNA-1975
Dispersione consegnata IM
Altri nomi:
  • RS1-7
Sperimentale: mRNA-1975: Dose 3
I partecipanti riceveranno 3 iniezioni IM del vaccino mRNA-1975 al livello di dose 3 nei giorni 1, 57 e 169.
Biologico: mRNA-1975
Dispersione consegnata IM
Altri nomi:
  • RS1-7
Sperimentale: mRNA-1975: Dose 4
I partecipanti riceveranno 3 iniezioni IM del vaccino mRNA-1975 al livello di dose 4 nei giorni 1, 57 e 169.
Biologico: mRNA-1975
Dispersione consegnata IM
Altri nomi:
  • RS1-7
Sperimentale: mRNA-1982: Dose 1
I partecipanti riceveranno 3 iniezioni IM del vaccino mRNA-1982 al livello di dose 1 nei giorni 1, 57 e 169.
Biologico: mRNA-1982
Dispersione consegnata IM
Altri nomi:
  • RS1
Sperimentale: mRNA-1982: Dose 2
I partecipanti riceveranno 3 iniezioni IM del vaccino mRNA-1982 al livello di dose 2 nei giorni 1, 57 e 169.
Biologico: mRNA-1982
Dispersione consegnata IM
Altri nomi:
  • RS1
Sperimentale: mRNA-1982: Dose 3
I partecipanti riceveranno 3 iniezioni IM del vaccino mRNA-1982 al livello di dose 3 nei giorni 1, 57 e 169.
Biologico: mRNA-1982
Dispersione consegnata IM
Altri nomi:
  • RS1
Comparatore placebo: Placebo
I partecipanti riceveranno 3 iniezioni IM di placebo corrispondente al vaccino nei giorni 1, 57 e 169.
Biologico: Placebo
Soluzione consegnata IM

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) Within 7 Days After Day 1 Injection
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Deaths Related to Study Drug
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

ModernaTX, Inc.

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

26 luglio 2023

Completamento primario (Effettivo)

30 maggio 2025

Completamento dello studio (Effettivo)

30 maggio 2025

Date di iscrizione allo studio

Primo inviato

26 luglio 2023

Primo inviato che soddisfa i criteri di controllo qualità

26 luglio 2023

Primo Inserito (Effettivo)

3 agosto 2023

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

30 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • mRNA-1975/1982-P101

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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