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Tutkimus mRNA-1975:n ja mRNA-1982:n turvallisuuden ja immunogeenisyyden arvioimiseksi Lymen tautia vastaan ​​18–70-vuotiailla osallistujilla

maanantai 6. heinäkuuta 2026 päivittänyt: ModernaTX, Inc.

Vaihe 1/2, satunnaistettu, tarkkailijasokeutettu, lumekontrolloitu, annosvälitteinen tutkimus heptavalentin mRNA-1975:n (SR1-7) ja yksiarvoisen mRNA-1982:n (SR1) turvallisuuden ja immunogeenisyyden arvioimiseksi rinnakkaishoidossa Lymen tautia vastaan Terveet osallistujat 18–70-vuotiaat

Tämän tutkimuksen tarkoituksena on arvioida heptavalentin mRNA-1975:n ja monovalentin mRNA-1982:n turvallisuutta ja immunogeenisyyttä rinnakkain Lymen tautia vastaan ​​terveillä aikuisilla osallistujilla.

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

807

Vaihe

  • Vaihe 2
  • Vaihe 1

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

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

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

  • Aikuinen
  • Vanhempi Aikuinen

Hyväksyy terveitä vapaaehtoisia

Joo

Kuvaus

Sisällyttämiskriteerit:

  • Painoindeksi 18-39 kiloa/neliömetri (mukaan lukien) seulontakäynnillä.
  • Tutkimukseen voidaan ottaa mukaan osallistujia, jotka eivät ole raskaana.
  • Hedelmällisessä iässä olevat naispuoliset osallistujat: negatiivinen raskaustesti, riittävä ehkäisy tai hän on pidättäytynyt kaikista toiminnoista, jotka voivat johtaa raskauteen tutkimuksen interventiojakson aikana, ja suostumus jatkamaan riittävää ehkäisyä tai pidättymistä 3 kuukauden ajan viimeisestä tutkimusinjektiosta.

Poissulkemiskriteerit:

  • sinulla on krooninen Lymen tautiin liittyvä sairaus tai lääkärin epäilemä tai diagnosoima aktiivinen oireinen Lymen taudin infektio.
  • Sai hoitoa Lymen taudista edellisten 3 kuukauden aikana.
  • Hän oli aiemmin rokotettu Lymen tautia vastaan ​​tai osallistunut aiemmin mihin tahansa Lymen taudin rokotetutkimukseen.
  • Oli punkin purema 4 viikon sisällä ennen tutkimusinjektiokäyntiä.
  • Dermatologiset sairaudet, jotka voivat vaikuttaa paikallisiin tilattuihin AR-arviointeihin (esimerkiksi tatuoinnit; olkalihasten ihoon vaikuttavat psoriaasiläiskit).
  • Sai systeemisiä immunosuppressiivisia lääkkeitä yhteensä > 14 päivän ajan 180 päivän aikana ennen seulontakäyntiä (kortikosteroidien osalta ≥ 10 milligrammaa/päivä prednisonia tai vastaavaa) tai ennakoi systeemisen immunosuppressiivisen hoidon tarvetta milloin tahansa tutkimukseen osallistumisen aikana.
  • Aiempi sydänlihastulehdus, perikardiitti tai myoperikardiitti riippumatta aiemman sairaushistorian ajoituksesta.
  • Aiempi anafylaksia, nokkosihottuma tai muu merkittävä haittavaikutus, joka vaatii lääketieteellistä toimenpiteitä rokotteen tai toimenpiteen, joka sisältää yhtä tai useampaa tutkimusinjektioon sisältynyttä komponenttia, vastaanottamisen jälkeen.
  • On saanut systeemisiä immunoglobuliineja, pitkävaikutteisia immuunivasteisiin vaikuttavia biologisia hoitoja (esim. infliksimabi) tai verituotteita 90 päivän sisällä ennen seulontakäyntiä tai aikoo saada niitä tutkimuksen aikana.

Huomautus: Muut sisällyttämis- ja poissulkemiskriteerit voivat olla voimassa.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Kaksinkertainen

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: mRNA-1975: Annos 1
Osallistujat saavat 3 intramuskulaarista (IM) injektiota mRNA-1975-rokotteella annostasolla 1 päivinä 1, 57 ja 169.
Biologinen: mRNA-1975
Dispersio toimitettu IM
Muut nimet:
  • SR1-7
Kokeellinen: mRNA-1975: Annos 2
Osallistujat saavat 3 IM-injektiota mRNA-1975-rokotteella annostasolla 2 päivinä 1, 57 ja 169.
Biologinen: mRNA-1975
Dispersio toimitettu IM
Muut nimet:
  • SR1-7
Kokeellinen: mRNA-1975: Annos 3
Osallistujat saavat 3 IM-injektiota mRNA-1975-rokotteella annostasolla 3 päivinä 1, 57 ja 169.
Biologinen: mRNA-1975
Dispersio toimitettu IM
Muut nimet:
  • SR1-7
Kokeellinen: mRNA-1975: Annos 4
Osallistujat saavat 3 IM-injektiota mRNA-1975-rokotetta annostasolla 4 päivinä 1, 57 ja 169.
Biologinen: mRNA-1975
Dispersio toimitettu IM
Muut nimet:
  • SR1-7
Kokeellinen: mRNA-1982: Annos 1
Osallistujat saavat 3 IM-injektiota mRNA-1982-rokotteella annostasolla 1 päivinä 1, 57 ja 169.
Biologinen: mRNA-1982
Dispersio toimitettu IM
Muut nimet:
  • SR1
Kokeellinen: mRNA-1982: Annos 2
Osallistujat saavat 3 IM-injektiota mRNA-1982-rokotteella annostasolla 2 päivinä 1, 57 ja 169.
Biologinen: mRNA-1982
Dispersio toimitettu IM
Muut nimet:
  • SR1
Kokeellinen: mRNA-1982: Annos 3
Osallistujat saavat 3 imRNA-1982-rokotteen im-injektiota annostasolla 3 päivinä 1, 57 ja 169.
Biologinen: mRNA-1982
Dispersio toimitettu IM
Muut nimet:
  • SR1
Placebo Comparator: Plasebo
Osallistujat saavat 3 im-injektiota rokotetta vastaavaa lumelääkettä päivinä 1, 57 ja 169.
Biologinen: Plasebo
Ratkaisu toimitettu pikaviestillä

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) Within 7 Days After Day 1 Injection
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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

Muut tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Number of Deaths Related to Study Drug
Aikaikkuna: 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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

ModernaTX, Inc.

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

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Opintojen ennätyspäivät

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Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • mRNA-1975/1982-P101

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Joo

Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

Ei

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