En undersøgelse til evaluering af sikkerheden og immunogeniciteten af mRNA-1975 og mRNA-1982 mod Lyme-sygdom hos deltagere i alderen 18 til 70 år
6. juli 2026 opdateret af: ModernaTX, Inc.
En fase 1/2, randomiseret, observatør-blind, placebo-kontrolleret, dosisvarierende undersøgelse til evaluering af sikkerheden og immunogeniciteten af heptavalent mRNA-1975 (SR1-7) og monovalent mRNA-1982 (SR1) parallelt mod Lyme-sygdom i Sunde deltagere i alderen 18 til 70 år
Formålet med denne undersøgelse er at evaluere sikkerheden og immunogeniciteten parallelt med heptavalent mRNA-1975 og monovalent mRNA-1982 mod Lyme-sygdom hos raske voksne deltagere.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
807
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Connecticut
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Milford, Connecticut, Forenede Stater, 06460
- Clinical Research Consulting, LLC
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Stamford, Connecticut, Forenede Stater, 06905
- Stamford Therapeutics Consortium
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Waterbury, Connecticut, Forenede Stater, 06708
- Chase Medical Research, LLC
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Florida
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Jacksonville, Florida, Forenede Stater, 32216
- Encore Research Group-Jacksonville Center for Clinical Research
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Lake Mary, Florida, Forenede Stater, 32746
- University Clinical Research-DeLand, LLC d/b/a Accel Research Sites
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Georgia
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Stockbridge, Georgia, Forenede Stater, 30281
- Clinical Research Atlanta, headlands LLC
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Kansas
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Lenexa, Kansas, Forenede Stater, 66219
- Johnson County Clin-Trials, Inc. (JCCT)
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Maryland
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Columbia, Maryland, Forenede Stater, 21045
- Centennial Medical Group
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Rockville, Maryland, Forenede Stater, 20850
- Advanced Primary and Geriatric Care
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Massachusetts
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Brookline, Massachusetts, Forenede Stater, 02445
- DM Clinical Research - Brookline
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Minnesota
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Minneapolis, Minnesota, Forenede Stater, 55402
- Clinical Research Institute, Inc.
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Nebraska
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Omaha, Nebraska, Forenede Stater, 68134
- Meridian Clinical Research - Omaha
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New Hampshire
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Newington, New Hampshire, Forenede Stater, 03801
- ActivMed Research LLC
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New York
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Rochester, New York, Forenede Stater, 14609
- Rochester Clinical Research, Inc.
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73112
- Lynn Health Science Institute
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Pennsylvania
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Hatboro, Pennsylvania, Forenede Stater, 19040
- Hatboro Medical Associates/CCT Research
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Rhode Island
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Providence, Rhode Island, Forenede Stater, 02886
- Velocity Clinical Research Providence
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Texas
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Fort Worth, Texas, Forenede Stater, 76135
- Benchmark Research
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Tomball, Texas, Forenede Stater, 77375
- DM Clinical Research
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Virginia
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Charlottesville, Virginia, Forenede Stater, 22911
- Charlottesville Medical Research Center, LLC
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
Inklusionskriterier:
- Body mass index på 18 til 39 kg/kvadratmeter (inklusive) ved screeningsbesøget.
- Deltagere af ikke-fertil alder kan blive tilmeldt undersøgelsen.
- For kvindelige deltagere i den fødedygtige alder: negativ graviditetstest, tilstrækkelig prævention eller har afstået fra alle aktiviteter, der kunne resultere i graviditet i løbet af undersøgelsens interventionsperiode, og aftale om at fortsætte tilstrækkelig prævention eller afholdenhed i 3 måneder efter sidste undersøgelsesindsprøjtning.
Ekskluderingskriterier:
- Har kronisk sygdom relateret til borreliose eller en aktiv symptomatisk borreliose-infektion som mistænkt eller diagnosticeret af en læge.
- Modtaget behandling for borreliose inden for de foregående 3 måneder.
- Havde tidligere vaccineret mod borreliose eller har tidligere deltaget i en hvilken som helst vaccineundersøgelse for borreliose.
- Havde et flåtbid inden for 4 uger før undersøgelsens injektionsbesøg.
- Dermatologiske tilstande, der kan påvirke lokale anmodede AR-vurderinger (f.eks. tatoveringer; psoriasispletter, der påvirker huden over deltoideusområderne).
- Modtaget systemiske immunsuppressiva i >14 dage i alt inden for 180 dage før screeningsbesøget (for kortikosteroider, ≥10 milligram/dag af prednison eller tilsvarende) eller forudser behovet for systemisk immunsuppressiv behandling på et hvilket som helst tidspunkt under deltagelse i undersøgelsen.
- Anamnese med myocarditis, pericarditis eller myopericarditis uanset tidspunktet for tidligere sygehistorie.
- Anamnese med anafylaksi, nældefeber eller andre væsentlige bivirkninger, der kræver medicinsk indgriben efter modtagelse af en vaccine eller intervention, der omfatter en eller flere af de samme komponenter indeholdt i undersøgelsesinjektionen.
- Har modtaget systemiske immunglobuliner, langtidsvirkende biologiske terapier, der påvirker immunresponser (f.eks. infliximab) eller blodprodukter inden for 90 dage før screeningsbesøget eller planlægger at modtage dem under undersøgelsen.
Bemærk: Andre inklusions- og eksklusionskriterier kan være gældende.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: mRNA-1975: Dosis 1
Deltagerne vil modtage 3 intramuskulære (IM) injektioner af mRNA-1975-vaccinen på dosisniveau 1 på dag 1, 57 og 169.
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Dispersion leveret IM
Andre navne:
|
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Eksperimentel: mRNA-1975: Dosis 2
Deltagerne vil modtage 3 IM-injektioner af mRNA-1975-vaccinen på dosisniveau 2 på dag 1, 57 og 169.
|
Dispersion leveret IM
Andre navne:
|
|
Eksperimentel: mRNA-1975: Dosis 3
Deltagerne vil modtage 3 IM-injektioner af mRNA-1975-vaccinen på dosisniveau 3 på dag 1, 57 og 169.
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Dispersion leveret IM
Andre navne:
|
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Eksperimentel: mRNA-1975: Dosis 4
Deltagerne vil modtage 3 IM-injektioner af mRNA-1975-vaccinen på dosisniveau 4 på dag 1, 57 og 169.
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Dispersion leveret IM
Andre navne:
|
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Eksperimentel: mRNA-1982: Dosis 1
Deltagerne vil modtage 3 IM-injektioner af mRNA-1982-vaccinen på dosisniveau 1 på dag 1, 57 og 169.
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Dispersion leveret IM
Andre navne:
|
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Eksperimentel: mRNA-1982: Dosis 2
Deltagerne vil modtage 3 IM-injektioner af mRNA-1982-vaccinen på dosisniveau 2 på dag 1, 57 og 169.
|
Dispersion leveret IM
Andre navne:
|
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Eksperimentel: mRNA-1982: Dosis 3
Deltagerne vil modtage 3 IM-injektioner af mRNA-1982-vaccinen på dosisniveau 3 på dag 1, 57 og 169.
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Dispersion leveret IM
Andre navne:
|
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Placebo komparator: Placebo
Deltagerne vil modtage 3 IM-injektioner af vaccine-matchende placebo på dag 1, 57 og 169.
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Løsning leveret IM
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) Within 7 Days After Day 1 Injection
Tidsramme: 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.
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Up to 7 days after Day 1 injection
|
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Number of Participants With Solicited Local and Systemic ARs Within 7 Days After Day 57 Injection
Tidsramme: 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.
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Up to 7 days after Day 57 injection
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Number of Participants With Solicited Local and Systemic ARs Within 7 Days After Day 169 Injection
Tidsramme: 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.
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Up to 7 days after Day 169 injection
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Number of Participants With Unsolicited AEs
Tidsramme: Up to 28 days post any injection
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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.
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Up to 28 days post any injection
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Number of Participants With Medically Attended AEs (MAAEs), Adverse Events of Special Interest (AESIs), SAEs, and AEs Leading to Study Discontinuation
Tidsramme: 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.
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Day 1 up to Month 18
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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)
Tidsramme: 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.
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Days 1, 29, 85 and 197
|
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GMC of Anti-OspA Binding IgG Antibodies for SR-2 Antigen Measured by ELISA
Tidsramme: 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
|
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GMC of Anti-OspA Binding IgG Antibodies for SR-3 Antigen Measured by ELISA
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Deaths Related to Study Drug
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
26. juli 2023
Primær færdiggørelse (Faktiske)
30. maj 2025
Studieafslutning (Faktiske)
30. maj 2025
Datoer for studieregistrering
Først indsendt
26. juli 2023
Først indsendt, der opfyldte QC-kriterier
26. juli 2023
Først opslået (Faktiske)
3. august 2023
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
30. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- mRNA-1975/1982-P101
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .