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Um estudo para avaliar a segurança e a imunogenicidade do mRNA-1975 e do mRNA-1982 contra a doença de Lyme em participantes de 18 a 70 anos de idade

6 de julho de 2026 atualizado por: ModernaTX, Inc.

Um estudo de Fase 1/2, randomizado, cego, controlado por placebo, de variação de dose para avaliar a segurança e a imunogenicidade do mRNA-1975 heptavalente (SR1-7) e mRNA-1982 monovalente (SR1) em paralelo contra a doença de Lyme em Participantes saudáveis ​​de 18 a 70 anos de idade

O objetivo deste estudo é avaliar a segurança e a imunogenicidade paralelamente do mRNA-1975 heptavalente e do mRNA-1982 monovalente contra a doença de Lyme em participantes adultos saudáveis.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

807

Estágio

  • Fase 2
  • Fase 1

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Descrição

Critério de inclusão:

  • Índice de massa corporal de 18 a 39 quilogramas/metro quadrado (inclusive) na visita de triagem.
  • Participantes sem potencial para engravidar podem ser incluídos no estudo.
  • Para participantes do sexo feminino com potencial para engravidar: teste de gravidez negativo, contracepção adequada ou abstinência de todas as atividades que possam resultar em gravidez durante o período de intervenção do estudo e concordância em continuar a contracepção adequada ou abstinência por 3 meses após a última injeção do estudo.

Critério de exclusão:

  • Ter uma doença crônica relacionada à doença de Lyme ou uma infecção ativa sintomática da doença de Lyme conforme suspeita ou diagnóstico por um médico.
  • Recebeu tratamento para a doença de Lyme nos últimos 3 meses.
  • Teve vacinação anterior contra a doença de Lyme ou participou no passado em qualquer estudo de vacina para a doença de Lyme.
  • Teve uma picada de carrapato dentro de 4 semanas antes da visita de injeção do estudo.
  • Condições dermatológicas que podem afetar as avaliações locais de AR solicitadas (por exemplo, tatuagens; manchas de psoríase afetando a pele sobre as áreas deltóides).
  • Recebeu imunossupressores sistêmicos por >14 dias no total dentro de 180 dias antes da Visita de Triagem (para corticosteroides, ≥10 miligramas/dia de prednisona ou equivalente) ou está antecipando a necessidade de tratamento imunossupressor sistêmico a qualquer momento durante a participação no estudo.
  • História de miocardite, pericardite ou miopericardite, independentemente do momento da história médica pregressa.
  • História de anafilaxia, urticária ou outra reação adversa significativa que requeira intervenção médica após o recebimento de uma vacina ou intervenção que inclua um ou mais dos mesmos componentes contidos na injeção do estudo.
  • Recebeu imunoglobulinas sistêmicas, terapias biológicas de ação prolongada que afetam as respostas imunes (por exemplo, infliximabe) ou hemoderivados 90 dias antes da visita de triagem ou planeja recebê-los durante o estudo.

Nota: Outros critérios de inclusão e exclusão podem ser aplicados.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: mRNA-1975: Dose 1
Os participantes receberão 3 injeções intramusculares (IM) da vacina mRNA-1975 no nível de dose 1 nos dias 1, 57 e 169.
Biológico: mRNA-1975
Dispersão entregue IM
Outros nomes:
  • SR1-7
Experimental: mRNA-1975: Dose 2
Os participantes receberão 3 injeções IM da vacina mRNA-1975 no nível de dose 2 nos dias 1, 57 e 169.
Biológico: mRNA-1975
Dispersão entregue IM
Outros nomes:
  • SR1-7
Experimental: mRNA-1975: Dose 3
Os participantes receberão 3 injeções IM da vacina mRNA-1975 no nível de dose 3 nos dias 1, 57 e 169.
Biológico: mRNA-1975
Dispersão entregue IM
Outros nomes:
  • SR1-7
Experimental: mRNA-1975: Dose 4
Os participantes receberão 3 injeções IM da vacina mRNA-1975 no nível de dose 4 nos dias 1, 57 e 169.
Biológico: mRNA-1975
Dispersão entregue IM
Outros nomes:
  • SR1-7
Experimental: mRNA-1982: Dose 1
Os participantes receberão 3 injeções IM da vacina mRNA-1982 no nível de dose 1 nos dias 1, 57 e 169.
Biológico: mRNA-1982
Dispersão entregue IM
Outros nomes:
  • SR1
Experimental: mRNA-1982: Dose 2
Os participantes receberão 3 injeções IM da vacina mRNA-1982 no nível de dose 2 nos dias 1, 57 e 169.
Biológico: mRNA-1982
Dispersão entregue IM
Outros nomes:
  • SR1
Experimental: mRNA-1982: Dose 3
Os participantes receberão 3 injeções IM da vacina mRNA-1982 no nível de dose 3 nos dias 1, 57 e 169.
Biológico: mRNA-1982
Dispersão entregue IM
Outros nomes:
  • SR1
Comparador de Placebo: Placebo
Os participantes receberão 3 injeções IM de placebo correspondente à vacina nos dias 1, 57 e 169.
Biológico: Placebo
Solução entregue IM

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) Within 7 Days After Day 1 Injection
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Number of Deaths Related to Study Drug
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

ModernaTX, Inc.

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

26 de julho de 2023

Conclusão Primária (Real)

30 de maio de 2025

Conclusão do estudo (Real)

30 de maio de 2025

Datas de inscrição no estudo

Enviado pela primeira vez

26 de julho de 2023

Enviado pela primeira vez que atendeu aos critérios de CQ

26 de julho de 2023

Primeira postagem (Real)

3 de agosto de 2023

Atualizações de registro de estudo

Última Atualização Postada (Real)

30 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

6 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • mRNA-1975/1982-P101

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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