Um estudo sobre vacinas de RNA modificado contra influenza em adultos saudáveis
9 de junho de 2026 atualizado por: Pfizer
UM ESTUDO PARA AVALIAR A SEGURANÇA, TOLERABILIDADE E IMUNOGENICIDADE DE VACINAS DE RNA MODIFICADAS CONTRA A INFLUENZA EM ADULTOS SAUDÁVEIS
O objetivo deste estudo é saber se as vacinas de RNA modificado (modRNA) para a prevenção da gripe são:
- seguro; e
- como essas vacinas produzem uma resposta imunológica em adultos geralmente saudáveis. A resposta imunológica é a forma como o corpo se protege contra coisas que considera prejudiciais ou estranhas.
O RNA (também chamado de ácido ribonucleico) é um dos dois tipos de ácido nucleico produzido pelas células. O RNA contém informações que foram copiadas do DNA (o outro tipo de ácido nucleico). As células produzem várias formas diferentes de RNA, e cada forma tem uma função específica na célula. Muitas formas de RNA têm funções relacionadas à produção de proteínas. O RNA também é o material genético de alguns vírus, em vez do DNA. O RNA pode ser produzido em laboratório e usado em pesquisas. Também chamado de ácido ribonucléico.
Gripe é o termo usado para designar doenças gripais. É uma infecção causada por um vírus que afeta boca, nariz e garganta.
O estudo está buscando participantes que:
- têm pelo menos 18 anos de idade
- não recebeu uma vacina contra influenza nos últimos 6 meses
- geralmente são saudáveis
Este estudo será dividido em três subestudos: Subestudo A (SSA), Subestudo B (SSB) e Subestudo C (SSC).
Todos os participantes, independentemente do subestudo, receberão 1 dose de qualquer uma das seguintes vacinas por injeção no braço:
- 1 das vacinas contra influenza modRNA que está sendo estudada; ou
- uma vacina contra influenza aprovada para uso em sua respectiva faixa etária.
Os participantes estarão envolvidos neste estudo por cerca de 6 meses. Durante este tempo, os participantes terão pelo menos 3 visitas clínicas.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
1202
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
-
-
Alabama
-
Mobile, Alabama, Estados Unidos, 36608
- AMR Clinical
-
-
Arizona
-
Scottsdale, Arizona, Estados Unidos, 85260
- Headlands Research - Scottsdale
-
-
California
-
Anaheim, California, Estados Unidos, 92801
- Anaheim Clinical Trials, LLC
-
Lake Forest, California, Estados Unidos, 92630
- Orange County Research Center
-
San Diego, California, Estados Unidos, 92103
- Artemis Institute for Clinical Research
-
Walnut Creek, California, Estados Unidos, 94598
- Diablo Clinical Research, Inc.
-
-
Connecticut
-
Milford, Connecticut, Estados Unidos, 06460
- Clinical Research Consulting
-
-
Florida
-
Hialeah, Florida, Estados Unidos, 33012
- Indago Research & Health Center, Inc
-
Hollywood, Florida, Estados Unidos, 33024
- Research Centers of America
-
Hollywood, Florida, Estados Unidos, 33024
- Research Centers of America ( Hollywood )
-
Miami Lakes, Florida, Estados Unidos, 33014
- Palm Springs Community Health Center
-
Orlando, Florida, Estados Unidos, 32801
- Clinical Neuroscience Solutions, Inc.
-
Orlando, Florida, Estados Unidos, 32819
- Headlands Research Orlando
-
South Miami, Florida, Estados Unidos, 33143
- Qps-Mra, Llc
-
-
Hawaii
-
Honolulu, Hawaii, Estados Unidos, 96814
- East-West Medical Research Institute
-
-
Louisiana
-
New Orleans, Louisiana, Estados Unidos, 70119
- Alliance for Multispecialty Research, LLC
-
-
Minnesota
-
Saint Paul, Minnesota, Estados Unidos, 55114
- Prism Research LLC dba Nucleus Network
-
-
Missouri
-
Chesterfield, Missouri, Estados Unidos, 63005
- Clinical Research Professionals
-
Kansas City, Missouri, Estados Unidos, 64114
- Alliance for Multispecialty Research, LLC
-
-
New York
-
Rochester, New York, Estados Unidos, 14609
- Rochester Clinical Research, LLC
-
-
North Carolina
-
Durham, North Carolina, Estados Unidos, 27703
- Duke Vaccine and Trials Unit
-
Raleigh, North Carolina, Estados Unidos, 27612
- M3 Wake Research, Inc.
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Estados Unidos, 19107
- DM Clinical Research - Philadelphia
-
-
Texas
-
Brownsville, Texas, Estados Unidos, 78526
- Headlands Horizons LLC
-
Mesquite, Texas, Estados Unidos, 75149
- SMS Clinical Research
-
San Antonio, Texas, Estados Unidos, 78229
- Clinical Trials of Texas, LLC
-
San Antonio, Texas, Estados Unidos, 78229
- Clinical Trials of Texas, LLC dba Flourish Research
-
Tomball, Texas, Estados Unidos, 77375
- Dynamed Clinical Research, LP d/b/a DM Clinical Research
-
-
Utah
-
Salt Lake City, Utah, Estados Unidos, 84109
- J. Lewis Research, Inc. / Foothill Family Clinic
-
Salt Lake City, Utah, Estados Unidos, 84121
- J. Lewis Research, Inc. / Foothill Family Clinic South
-
-
Virginia
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Charlottesville, Virginia, Estados Unidos, 22911
- Charlottesville Medical Research
-
Norfolk, Virginia, Estados Unidos, 23502
- AMR Clinical
-
-
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
Principais critérios de inclusão
Aplica-se a todos os 3 subestudos:
- participantes ≥18 anos de idade.
- participantes geralmente saudáveis.
SOMENTE Subestudo C:
- recebimento de vacinação contra influenza licenciada para a temporada de gripe 2023-2024 há pelo menos 6 meses.
Principais critérios de exclusão
Todos os 3 subestudos:
- diagnóstico de gripe (por testes clínicos) nos últimos 6 meses.
- indivíduos imunocomprometidos com imunodeficiência conhecida ou suspeita
- recebimento de qualquer vacina experimental ou licenciada contra influenza dentro de 6 meses.
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: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: SSA: Vacina Influenza ModRNA 2A
- Dose única no dia 1
|
Injeção intramuscular
|
|
Experimental: SSA: Vacina Influenza ModRNA 3A
- Dose única no dia 1
|
Injeção intramuscular
|
|
Experimental: SSA: Vacina Influenza ModRNA 4A
- Dose única no dia 1
|
Injeção intramuscular
|
|
Experimental: SSA: Vacina Influenza ModRNA 5A
- Dose única no Dia 1
|
Injeção intramuscular
|
|
Comparador Ativo: ASS: QIV1
- Dose única no Dia 1
|
Injeção intramuscular
|
|
Experimental: SSB: Vacina Influenza ModRNA 3B
- Dose única no dia 1
|
Injeção intramuscular
|
|
Experimental: SSB: Vacina Influenza ModRNA 4B
- Dose única no dia 1
|
Injeção intramuscular
|
|
Experimental: SSB: Vacina Influenza ModRNA 5B
- Dose única no Dia 1
|
Injeção intramuscular
|
|
Comparador Ativo: SSB: QIV2
- Dose única no dia 1
|
Injeção intramuscular
|
|
Comparador Ativo: SSB: QIV3
- Dose única no dia 1
|
Injeção intramuscular
|
|
Experimental: SSC: Vacina Influenza ModRNA 3C
- Dose única no dia 1
|
Injeção intramuscular
|
|
Experimental: SSC: Vacina Influenza ModRNA 4C
- Dose única no dia 1
|
Injeção intramuscular
|
|
Experimental: SSC: Vacina Influenza ModRNA 5C
- Dose única no dia 1
|
Injeção intramuscular
|
|
Experimental: SSC: Vacina Influenza ModRNA 6C
- Dose única no dia 1
|
Injeção intramuscular
|
|
Experimental: SSC: Vacina Influenza ModRNA 7C
- Dose única no dia 1
|
Injeção intramuscular
|
|
Experimental: SSC: Vacina Influenza ModRNA 8C
- Dose única no dia 1
|
Injeção intramuscular
|
|
Experimental: SSC: Vacina Influenza ModRNA 9C
- Dose única no Dia 1
|
Injeção intramuscular
|
|
Comparador Ativo: SSC: QIV2
- Dose única no dia 1
|
Injeção intramuscular
|
|
Comparador Ativo: SSC: QIV3
- Dose única no dia 1
|
Injeção intramuscular
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
SSA: Percentage of Participants With Local Reactions for up to 7 Days Following Vaccination
Prazo: From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
|
Local reactions included pain at the injection site, redness and swelling and were recorded by participants in the electronic dairy (e-diary) or by investigators in case report form (CRF) after vaccination.
All local reactions were graded based on center for biologics evaluation and research (CBER) toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening).
In this outcome measure, data is reported as percentage of participants with any local reaction of any grade.
|
From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
|
|
SSB: Percentage of Participants With Local Reactions for up to 7 Days Following Vaccination
Prazo: From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
|
Local reactions included pain at the injection site, redness and swelling and were recorded by participants in the e-diary or by investigators in CRF after vaccination.
All local reactions were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening).
In this outcome measure, data is reported as percentage of participants with any local reaction of any grade.
|
From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
|
|
SSC: Percentage of Participants With Local Reactions for up to 7 Days Following Vaccination
Prazo: From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
|
Local reactions included pain at the injection site, redness and swelling and were recorded by participants in the e-diary or by investigators in CRF after vaccination.
All local reactions were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening).
In this outcome measure, data is reported as percentage of participants with any local reaction of any grade.
|
From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
|
|
SSA: Percentage of Participants With Systemic Events for up to 7 Days Following Vaccination
Prazo: From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
|
Systemic events (fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and joint pain) were recorded by participants in the e-diary or by investigators in CRF after vaccination.
All systemic events were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening).
In this outcome measure, data is reported as percentage of participants with any systemic events of any grade.
|
From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
|
|
SSB: Percentage of Participants With Systemic Events for up to 7 Days Following Vaccination
Prazo: From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
|
Systemic events (fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and joint pain) were recorded by participants in the e-diary or by investigators in CRF after vaccination.
All systemic events were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening).
In this outcome measure, data is reported as percentage of participants with any systemic events of any grade.
|
From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
|
|
SSC: Percentage of Participants With Systemic Events for up to 7 Days Following Vaccination
Prazo: From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
|
Systemic events (fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and joint pain) were recorded by participants in the e-diary or by investigators in CRF after vaccination.
All systemic events were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening).
In this outcome measure, data is reported as percentage of participants with any systemic events of any grade.
|
From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]
|
|
SSA: Percentage of Participants With Adverse Events (AEs) From Vaccination Through 4 Weeks After Vaccination
Prazo: From study vaccination on Day 1 through 4 weeks after study vaccination
|
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
|
From study vaccination on Day 1 through 4 weeks after study vaccination
|
|
SSB: Percentage of Participants With AEs From Vaccination Through 4 Weeks After Vaccination
Prazo: From study vaccination on Day 1 through 4 weeks after study vaccination
|
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
|
From study vaccination on Day 1 through 4 weeks after study vaccination
|
|
SSC: Percentage of Participants With AEs From Vaccination Through 4 Weeks After Vaccination
Prazo: From study vaccination on Day 1 through 4 weeks after study vaccination
|
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
|
From study vaccination on Day 1 through 4 weeks after study vaccination
|
|
SSA: Percentage of Participants With SAEs From Vaccination Through 6 Months After Vaccination
Prazo: From study vaccination on Day 1 through 6 months after study vaccination
|
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, any other pre-specified criteria in protocol of the study or other important medical event judged by the investigator.
|
From study vaccination on Day 1 through 6 months after study vaccination
|
|
SSB: Percentage of Participants With SAEs From Vaccination Through 6 Months After Vaccination
Prazo: From study vaccination on Day 1 through 6 months after study vaccination
|
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, any other pre-specified criteria in protocol of the study or other important medical event judged by the investigator.
|
From study vaccination on Day 1 through 6 months after study vaccination
|
|
SSC: Percentage of Participants With SAEs From Vaccination Through 6 Months After Vaccination
Prazo: From study vaccination on Day 1 through 6 months after study vaccination
|
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, any other pre-specified criteria in protocol of the study or other important medical event judged by the investigator.
|
From study vaccination on Day 1 through 6 months after study vaccination
|
|
SSA: Percentage of Participants With Medically Attended Adverse Events (MAEs) From Vaccination Through 6 Months After Vaccination
Prazo: From study vaccination on Day 1 through 6 months after study vaccination
|
An MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
|
From study vaccination on Day 1 through 6 months after study vaccination
|
|
SSB: Percentage of Participants With MAEs From Vaccination Through 6 Months After Vaccination
Prazo: From study vaccination on Day 1 through 6 months after study vaccination
|
An MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
|
From study vaccination on Day 1 through 6 months after study vaccination
|
|
SSC: Percentage of Participants With MAEs From Vaccination Through 6 Months After Vaccination
Prazo: From study vaccination on Day 1 through 6 months after study vaccination
|
An MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
|
From study vaccination on Day 1 through 6 months after study vaccination
|
|
SSA: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Vaccination Through 6 Months After Vaccination
Prazo: From study vaccination on Day 1 through 6 months after study vaccination
|
An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects (e.g., asthma).
|
From study vaccination on Day 1 through 6 months after study vaccination
|
|
SSB: Percentage of Participants With NDCMCs From Vaccination Through 6 Months After Vaccination
Prazo: From study vaccination on Day 1 through 6 months after study vaccination
|
An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects (e.g., asthma).
|
From study vaccination on Day 1 through 6 months after study vaccination
|
|
SSC: Percentage of Participants With NDCMCs From Vaccination Through 6 Months After Vaccination
Prazo: From study vaccination on Day 1 through 6 months after study vaccination
|
An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects (e.g., asthma).
|
From study vaccination on Day 1 through 6 months after study vaccination
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition Assay (HAI) Titers at Baseline and 4 Weeks After Vaccination
Prazo: Baseline (before study vaccination on Day 1), 4 weeks after study vaccination
|
GMTs and the corresponding 2-sided 95% confidence intervals (CIs) were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution).
|
Baseline (before study vaccination on Day 1), 4 weeks after study vaccination
|
|
SSA: Geometric Mean Fold Rise (GMFR) of Strain-Specific HAI Titers From Before Vaccination to 4 Weeks After Vaccination
Prazo: From before study vaccination on Day 1 up to 4 weeks after study vaccination
|
GMFR was defined as the geometric mean of the fold rise in the assay results from before vaccination to a specified time point after vaccination.
|
From before study vaccination on Day 1 up to 4 weeks after study vaccination
|
|
SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination
Prazo: 4 weeks after study vaccination
|
Seroconversion was defined as an HAI titer <1:10 prior to vaccination and >=1:40 at the time point of interest, or an HAI titer of >=1:10 prior to vaccination with at least a 4-fold rise at the time point of interest.
|
4 weeks after study vaccination
|
|
SSA: Percentage of Participants With HAI Titers >=1:40 For Each Strain at Baseline and 4 Weeks After Vaccination
Prazo: Baseline (before study vaccination on Day 1), 4 weeks after study vaccination
|
This measure is for percentage of participants achieving HAI titers >=1:40 for each strain.
|
Baseline (before study vaccination on Day 1), 4 weeks after study vaccination
|
|
SSB: GMTs of Strain-Specific HAI Titers at Baseline and 4 Weeks After Vaccination
Prazo: Baseline (before study vaccination on Day 1), 4 weeks after study vaccination
|
Baseline (before study vaccination on Day 1), 4 weeks after study vaccination
|
|
|
SSB: GMFRs of Strain-Specific HAI Titers From Before Vaccination to 4 Weeks After Vaccination
Prazo: From before study vaccination on Day 1 up to 4 weeks after study vaccination
|
From before study vaccination on Day 1 up to 4 weeks after study vaccination
|
|
|
SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination
Prazo: 4 weeks after study vaccination
|
4 weeks after study vaccination
|
|
|
SSB: Percentage of Participants With HAI Titers >=1:40 For Each Strain at Baseline and 4 Weeks After Vaccination
Prazo: Baseline (before study vaccination on Day 1), 4 weeks after study vaccination
|
This measure is for percentage of participants achieving HAI titers >=1:40 for each strain.
|
Baseline (before study vaccination on Day 1), 4 weeks after study vaccination
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Pfizer CT.gov Call Center, Pfizer
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.
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)
23 de maio de 2024
Conclusão Primária (Real)
5 de fevereiro de 2025
Conclusão do estudo (Real)
5 de fevereiro de 2025
Datas de inscrição no estudo
Enviado pela primeira vez
24 de maio de 2024
Enviado pela primeira vez que atendeu aos critérios de CQ
30 de maio de 2024
Primeira postagem (Real)
31 de maio de 2024
Atualizações de registro de estudo
Última Atualização Postada (Real)
12 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
9 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- C4781013
- NCT06436703 (Identificador de registro: ClinicalTrials.gov)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
A Pfizer fornecerá acesso a dados individuais de participantes não identificados e documentos de estudo relacionados (por exemplo,
protocolo, Plano de Análise Estatística (SAP), Relatório de Estudo Clínico (CSR)) mediante solicitação de pesquisadores qualificados e sujeito a determinados critérios, condições e exceções.
Mais detalhes sobre os critérios de compartilhamento de dados da Pfizer e o processo para solicitação de acesso podem ser encontrados em: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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 .