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En studie för att utvärdera säkerheten och immunogeniciteten hos mRNA-1975 och mRNA-1982 mot borrelia hos deltagare i åldern 18 till 70 år

6 juli 2026 uppdaterad av: ModernaTX, Inc.

En fas 1/2, randomiserad, observatörsblind, placebokontrollerad, dosvarierande studie för att utvärdera säkerheten och immunogeniciteten av heptavalent mRNA-1975 (SR1-7) och monovalent mRNA-1982 (SR1) parallellt mot borrelia i Friska deltagare 18 till 70 år

Syftet med denna studie är att utvärdera säkerheten och immunogeniciteten parallellt med heptavalent mRNA-1975 och monovalent mRNA-1982 mot borrelia hos friska vuxna deltagare.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

807

Fas

  • Fas 2
  • Fas 1

Kontakter och platser

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

Studieorter

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

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

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Beskrivning

Inklusionskriterier:

  • Body mass index på 18 till 39 kilogram/kvadratmeter (inklusive) vid screeningbesöket.
  • Deltagare med icke-fertil ålder kan inkluderas i studien.
  • För kvinnliga deltagare i fertil ålder: negativt graviditetstest, adekvat preventivmedel eller har avstått från alla aktiviteter som kan resultera i graviditet under studiens interventionsperiod, samt överenskommelse om att fortsätta med adekvat preventivmedel eller avhållsamhet under 3 månader efter den senaste studieinjektion.

Exklusions kriterier:

  • Har en kronisk sjukdom relaterad till borrelia eller en aktiv symtomatisk borreliainfektion som misstänks eller diagnostiserats av en läkare.
  • Fick behandling för borrelia inom de senaste 3 månaderna.
  • Hade tidigare vaccination mot borrelia eller deltagit tidigare i någon vaccinstudie mot borrelia.
  • Hade ett fästingbett inom 4 veckor före studieinjektionsbesöket.
  • Dermatologiska tillstånd som kan påverka lokala efterfrågade AR-bedömningar (till exempel tatueringar; psoriasisplåster som påverkar huden över deltoideusområdena).
  • Fick systemiska immunsuppressiva medel i totalt >14 dagar inom 180 dagar före screeningbesöket (för kortikosteroider, ≥10 milligram/dag av prednison eller motsvarande) eller förutser behovet av systemisk immunsuppressiv behandling när som helst under deltagandet i studien.
  • Historik av myokardit, perikardit eller myoperikardit oavsett tidpunkten för tidigare medicinsk historia.
  • Anamnes på anafylaxi, urtikaria eller andra betydande biverkningar som kräver medicinsk intervention efter mottagande av ett vaccin eller intervention som inkluderar en eller flera av samma komponenter som ingår i studieinjektionen.
  • Har fått systemiska immunglobuliner, långtidsverkande biologiska terapier som påverkar immunsvar (till exempel infliximab) eller blodprodukter inom 90 dagar före screeningbesöket eller planerar att få dem under studien.

Obs: Andra 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: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: mRNA-1975: Dos 1
Deltagarna kommer att få 3 intramuskulära (IM) injektioner av mRNA-1975-vaccinet vid dosnivå 1 dag 1, 57 och 169.
Biologisk: mRNA-1975
Dispersion levererad IM
Andra namn:
  • SR1-7
Experimentell: mRNA-1975: Dos 2
Deltagarna kommer att få 3 im-injektioner av mRNA-1975-vaccinet på dosnivå 2 på dagarna 1, 57 och 169.
Biologisk: mRNA-1975
Dispersion levererad IM
Andra namn:
  • SR1-7
Experimentell: mRNA-1975: Dos 3
Deltagarna kommer att få 3 im-injektioner av mRNA-1975-vaccinet vid dosnivå 3 på dagarna 1, 57 och 169.
Biologisk: mRNA-1975
Dispersion levererad IM
Andra namn:
  • SR1-7
Experimentell: mRNA-1975: Dos 4
Deltagarna kommer att få 3 im-injektioner av mRNA-1975-vaccinet på dosnivå 4 på dagarna 1, 57 och 169.
Biologisk: mRNA-1975
Dispersion levererad IM
Andra namn:
  • SR1-7
Experimentell: mRNA-1982: Dos 1
Deltagarna kommer att få 3 IM-injektioner av mRNA-1982-vaccinet vid dosnivå 1 på dagarna 1, 57 och 169.
Biologisk: mRNA-1982
Dispersion levererad IM
Andra namn:
  • SR1
Experimentell: mRNA-1982: Dos 2
Deltagarna kommer att få 3 IM-injektioner av mRNA-1982-vaccinet vid dosnivå 2 på dagarna 1, 57 och 169.
Biologisk: mRNA-1982
Dispersion levererad IM
Andra namn:
  • SR1
Experimentell: mRNA-1982: Dos 3
Deltagarna kommer att få 3 IM-injektioner av mRNA-1982-vaccinet på dosnivå 3 på dagarna 1, 57 och 169.
Biologisk: mRNA-1982
Dispersion levererad IM
Andra namn:
  • SR1
Placebo-jämförare: Placebo
Deltagarna kommer att få 3 IM-injektioner av vaccinmatchande placebo på dagarna 1, 57 och 169.
Biologisk: Placebo
Lösning levererad IM

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) Within 7 Days After Day 1 Injection
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Deaths Related to Study Drug
Tidsram: 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

Samarbetspartners och utredare

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

Sponsor

ModernaTX, Inc.

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

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)

26 juli 2023

Primärt slutförande (Faktisk)

30 maj 2025

Avslutad studie (Faktisk)

30 maj 2025

Studieregistreringsdatum

Först inskickad

26 juli 2023

Först inskickad som uppfyllde QC-kriterierna

26 juli 2023

Första postat (Faktisk)

3 augusti 2023

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

30 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • mRNA-1975/1982-P101

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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