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A Study of Investigational RSV/hMPV Combination and Investigational hMPV Vaccines in Younger and Older Adults

19 de agosto de 2026 atualizado por: GlaxoSmithKline

A Phase 1/2, Randomized, Controlled, Observer-blind, Multicentre Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of GSK Biologicals' Investigational Respiratory Syncytial Virus (RSV)/Human Metapneumovirus (hMPV) Combination and Investigational hMPV Vaccines When Administered Intramuscularly According to a Single Dose Schedule in Younger Adults ≥18 to ≤49 Years and Older Adults Aged ≥60 to ≤80 Years

The aim of this study is to evaluate the safety, reactogenicity, and immune response of the different formulations of the investigational RSV/hMPV combination vaccine and investigational hMPV vaccine in younger and older adults.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

1456

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.

Contato de estudo

Estude backup de contato

Locais de estudo

  • Austrália
    • New South Wales
      • Botany, New South Wales, Austrália, 2019
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Ronald Mak
    • Victoria
      • Camberwell, Victoria, Austrália, 3124
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Rishi Shah
  • Estados Unidos
    • Kansas
      • Lenexa, Kansas, Estados Unidos, 66219
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Thomas Kreamer
    • Washington
      • Seattle, Washington, Estados Unidos, 98104
        • Recrutamento
        • GSK Investigational Site
        • Contato:
        • Contato:
        • Investigador principal:
          • Nicole Ehrhardt

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

Inclusion criteria:

Participants are eligible to be included in the study only if all of the following criteria apply:

  • Written informed consent obtained from the participant prior to performance of any study-specific procedure.
  • Participants who can and will comply with the requirements of the protocol (e.g., completion of the eDiary, return for follow-up visits, ability to access and utilize a phone or other electronic communications).
  • Body Mass Index (BMI) between 18 kg/m^2 and 33 kg/m^2, inclusive.

Specific inclusion criteria for OA

  • A male or female between and including, 60 to 80 YOA at the time of the study intervention administration.
  • Healthy participants or medically stable patients as established by medical history and physical examination.

Specific inclusion criteria for YA

  • A male or female participant between and including 18 to 49 YOA at the time of the study intervention administration.
  • Healthy participants as established by medical history, clinical examination and laboratory assessment at screening.
  • Participants of non-childbearing potential may be enrolled in the clinical study.

  • Participant of childbearing potential may be enrolled in the study if the participant:

    • has used two methods of contraception, at-least one of which must be a highly effective method, and the other being male condom for male sexual partners of POCBP to be used during sexual intercourse (with the exception of sexual abstinence, vasectomized partner and male partner who has been sterilized, in which case contraception is not required), at-least 30 days prior to study intervention administration, and has agreed to continue using above contraception requirements for 8 weeks after study intervention administration.
    • has a negative serum pregnancy test at screening and negative urine pregnancy test prior to study intervention administration on Day 1.

Exclusion criteria:

Participants are excluded from participating in the study if any of the following criteria apply:

  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).
  • Any medical condition that in the judgment of the investigator would make IM injection unsafe.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., current malignancy, HIV) or immunosuppressive/cytotoxic therapy (e.g., medication used during cancer chemotherapy, organ transplantation, or to treat autoimmune disorders), based on medical history and physical examination (no laboratory testing required).
  • Acute or unstable chronic pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination and medical history.
  • Documented history of HIV, HBV, HCV infection.
  • History of RSV and /or hMPV-associated illness, diagnosed serologically or microbiologically in the last 12 months.
  • Recurrent history or uncontrolled neurological disorders or seizures, or history of demyelinating conditions (including GBS).
  • Any history of dementia or any medical condition that moderately or severely impairs cognition.
  • Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the clinical study.
  • Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study (e.g., life-threatening disease).
  • Use of any investigational or non-registered product (drug, vaccine, or invasive medical device) other than the study intervention during the period beginning 30 days before study intervention administration (Day -29 to Day 1), or within 5 half-lives, whichever is longer, or their planned use during the study period.
  • Has previously received an investigational or approved vaccine or antibody for prevention of hMPV and/or RSV-associated diseases.

  • Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune-modifying treatments at any time up to the end of the study.

    • Up to 3 months prior to the study intervention administration:

      • For corticosteroids, this will mean prednisone equivalent >=20 mg/day for adult participants. Inhaled, topical and intra-articular steroids are allowed.
      • Administration of immunoglobulins and/or any blood products or plasma derivatives.
    • Up to 6 months prior to study intervention administration: long-acting immune-modifying drugs including among others immunotherapy (e.g., TNF-inhibitors), monoclonal antibodies, antitumoral medication.
  • Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention.
  • History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures.
  • Participation of any study personnel or their immediate dependents, family, or household members.
  • Planned move during the study period that will prohibit participating in the study until study end.
  • Bedridden participants.

Specific exclusion criteria for OA population

  • Planned or actual administration of a vaccine not foreseen by the study protocol in the period beginning 30 days before study intervention administration (Day - 29 to Day 1), or their planned use 30 days after study intervention administration, with the exception of inactivated, subunit and split influenza vaccines or COVID-19 vaccines which can be administered up to 14 days before or from 14 days after the study intervention administration.

  • At screening (Phase 1 only), participants with:

    • >=Grade 2 abnormalities for the following parameters, regardless of clinical significance, should be excluded:

      • Hematologic: hemoglobin (Hb), white blood cells (WBC), platelets, absolute cell counts of lymphocytes, neutrophils, eosinophils,
      • Biochemical: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), bilirubin, creatinine, blood urea nitrogen (BUN).
    • Grade 1/mild hematologic and/ or biochemical laboratory abnormalities that are not clinically significant in the clinical judgment of the investigator, may be included.

Specific exclusion criteria for YA population

  • Pregnant or lactating participant.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions for 8 weeks after study intervention administration.
  • Planned or actual administration of a vaccine not foreseen by the study protocol in the period beginning 30 days before study intervention administration (Day - 29 to Day 1), or their planned use 30 days after study intervention administration.

  • At screening, participants with:

    • >=Grade 2 abnormalities for the following parameters, regardless of clinical significance, should be excluded:

      • Hematologic: Hb, WBC, platelets, absolute cell counts of lymphocytes, neutrophils, eosinophils,
      • Biochemical: ALT, AST, ALP, bilirubin, creatinine, BUN.
    • Grade 1/mild hematologic and/ or biochemical laboratory abnormalities that are not clinically significant in the clinical judgment of the investigator, may be included.
  • Use of any medication, including prescription and non-prescription drugs or herbal remedies (such as St. John's wort) beginning 14 days (or 5 half-lives) prior to study intervention administration and/or planned administration during the study period. Certain medications may be permitted (Eg: contraceptives for POCBP).

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 sequencial
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: RSV/hMPV_X_low dose_Ph1_Younger Adults (YA) Group
YA participants receive a single dose of RSV/hMPV_X low dose vaccine in Phase 1, at Day 1.
Biológico: RSV/hMPV_X low dose vaccine
RSV/hMPV_X low dose vaccine administered intramuscularly.
Experimental: RSV/hMPV_X_medium dose_Ph1_YA Group
YA participants receive a single dose of RSV/hMPV_X medium dose vaccine in Phase 1, at Day 1.
Biológico: RSV/hMPV_X medium dose vaccine
RSV/hMPV_X medium dose vaccine administered intramuscularly.
Experimental: RSV/hMPV_X_high dose_Ph1_YA Group
YA participants receive a single dose of RSV/hMPV_X high dose vaccine in Phase 1, at Day 1.
Biológico: RSV/hMPV_X high dose vaccine
RSV/hMPV_X high dose vaccine administered intramuscularly.
Experimental: hMPV_Y_high dose_Ph1_YA Group
YA participants receive a single dose of hMPV_Y high dose vaccine in Phase 1, at Day 1.
Biológico: hMPV_Y high dose vaccine
hMPV_Y high dose vaccine administered intramuscularly.
Experimental: hMPV_Z_low dose_Ph1_YA Group
YA participants receive a single dose of hMPV_Z low dose vaccine in Phase 1, at Day 1.
Biológico: hMPV_Z low dose vaccine
hMPV_Z low dose vaccine administered intramuscularly.
Experimental: hMPV_Z_medium dose_Ph1_YA Group
YA participants receive a single dose of hMPV_Z medium dose vaccine in Phase 1, at Day 1.
Biológico: hMPV_Z medium dose vaccine
hMPV_Z medium dose vaccine administered intramuscularly.
Experimental: hMPV_Z_high dose_Ph1_YA Group
YA participants receive a single dose of hMPV_Z high dose vaccine in Phase 1, at Day 1.
Biológico: hMPV_Z high dose vaccine
hMPV_Z high dose vaccine administered intramuscularly.
Comparador Ativo: Control Vaccine_Ph1_YA Group
YA participants receive a single dose of control vaccine in Phase 1, at Day 1.
Biológico: Control vaccine
Control vaccine administered intramuscularly.
Comparador de Placebo: Placebo_Ph1_YA Group
YA participants receive a single dose of placebo in Phase 1, at Day 1.
Produto combinado: Placebo
Placebo administered intramuscularly.
Experimental: hMPV_Y_low dose_Ph1_OA Group
OA participants receive a single dose of hMPV_Y low dose vaccine in Phase 1, at Day 1.
Biológico: hMPV_Y low dose vaccine
hMPV_Y low dose vaccine administered intramuscularly.
Experimental: hMPV_Z_low dose_Ph1_OA Group
OA participants receive a single dose of hMPV_Z low dose vaccine in Phase 1, at Day 1.
Biológico: hMPV_Z low dose vaccine
hMPV_Z low dose vaccine administered intramuscularly.
Experimental: hMPV_Z_medium dose_Ph1_OA Group
OA participants receive a single dose of hMPV_Z medium dose vaccine in Phase 1, at Day 1.
Biológico: hMPV_Z medium dose vaccine
hMPV_Z medium dose vaccine administered intramuscularly.
Experimental: hMPV_Z_high dose_Ph1_OA Group
OA participants receive a single dose of hMPV_Z high dose vaccine in Phase 1, at Day 1.
Biológico: hMPV_Z high dose vaccine
hMPV_Z high dose vaccine administered intramuscularly.
Experimental: RSV/hMPV_V_low dose_Ph1 and Ph2_Older Adults (OA) Group
OA participants receive a single dose of RSV/hMPV_V low dose vaccine in both Phase 1 and Phase 2, at Day 1.
Biológico: RSV/hMPV_V low dose vaccine
RSV/hMPV_V low dose vaccine administered intramuscularly.
Experimental: RSV/hMPV_V_medium dose_Ph1 and Ph2_OA Group
OA participants receive a single dose of RSV/hMPV_V medium dose vaccine in both Phase 1 and Phase 2, at Day 1.
Biológico: RSV/hMPV_V medium dose vaccine
RSV/hMPV_V medium dose vaccine administered intramuscularly.
Experimental: RSV/hMPV_V_high dose_Ph1 and Ph2_OA Group
OA participants receive a single dose of RSV/hMPV_V high dose vaccine in both Phase 1 and Phase 2, at Day 1.
Biológico: RSV/hMPV_V high dose vaccine
RSV/hMPV_V high dose vaccine administered intramuscularly.
Experimental: RSV/hMPV_W_low dose_Ph1 and Ph2_OA Group
OA participants receive a single dose of RSV/hMPV_W low dose vaccine in both Phase 1 and Phase 2, at Day 1.
Biológico: RSV/hMPV_W low dose vaccine
RSV/hMPV_W low dose vaccine administered intramuscularly.
Experimental: RSV/hMPV_W_medium dose_Ph1 and Ph2_OA Group
OA participants receive a single dose of RSV/hMPV_W medium dose vaccine in both Phase 1 and Phase 2, at Day 1.
Biológico: RSV/hMPV_W medium dose vaccine
RSV/hMPV_W medium dose vaccine administered intramuscularly.
Experimental: RSV/hMPV_W_high dose_Ph1 and Ph2_OA Group
OA participants receive a single dose of RSV/hMPV_W high dose vaccine in both Phase 1 and Phase 2, at Day 1.
Biológico: RSV/hMPV_W high dose vaccine
RSV/hMPV_W high dose vaccine administered intramuscularly.
Experimental: RSV/hMPV_X_low dose_Ph1 and Ph2_OA Group
OA participants receive a single dose of RSV/hMPV_X low dose vaccine in both Phase 1 and Phase 2, at Day 1.
Biológico: RSV/hMPV_X low dose vaccine
RSV/hMPV_X low dose vaccine administered intramuscularly.
Experimental: RSV/hMPV_X_medium dose_Ph1 and Ph2_OA Group
OA participants received a single dose of RSV/hMPV_X medium dose vaccine in both Phase 1 and Phase 2, at Day 1.
Biológico: RSV/hMPV_X medium dose vaccine
RSV/hMPV_X medium dose vaccine administered intramuscularly.
Experimental: RSV/hMPV_X_high dose_Ph1 and Ph2_OA Group
OA participants receive a single dose of RSV/hMPV_X high dose vaccine in both Phase 1 and Phase 2, at Day 1.
Biológico: RSV/hMPV_X high dose vaccine
RSV/hMPV_X high dose vaccine administered intramuscularly.
Experimental: hMPV_Y_medium dose_Ph1 and Ph2_OA Group
OA participants receive a single dose of hMPV_Y medium dose vaccine in both Phase 1 and Phase 2, at Day 1.
Biológico: hMPV_Y medium dose vaccine
hMPV_Y medium dose vaccine administered intramuscularly.
Experimental: hMPV_Y_high dose_Ph1 and Ph2_OA Group
OA participants receive a single dose of hMPV_Y high dose vaccine in both Phase 1 and Phase 2, at Day 1.
Biológico: hMPV_Y high dose vaccine
hMPV_Y high dose vaccine administered intramuscularly.
Comparador Ativo: Control Vaccine_Ph1 and Ph2_OA Group
OA participants receive a single dose of control vaccine in both Phase 1 and Phase 2, at Day 1.
Biológico: Control vaccine
Control vaccine administered intramuscularly.
Comparador de Placebo: Placebo_Ph1 and Ph2_OA Group
OA participants receive a single dose of placebo in both Phase 1 and Phase 2, at Day 1.
Produto combinado: Placebo
Placebo administered intramuscularly.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Number of Participants Reporting Solicited Administration Site Events
Prazo: Day 1 to Day 7
Solicited administration site events include pain, redness (erythema) and swelling at administration site.
Day 1 to Day 7
Number of Participants Reporting Solicited Systemic Events
Prazo: Day 1 to Day 7
Solicited systemic events include fever [defined as oral or axillary temperature greater than or equal to (>=) 38.0°C/100.4°F], headache, myalgia (muscle pain), arthralgia (joint pain) and fatigue (tiredness).
Day 1 to Day 7
Number of Participants Reporting Unsolicited Adverse Events (AEs)
Prazo: Day 1 to Day 30
An unsolicited AE is defined as an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow up for solicited events. Unsolicited AEs include both serious and non-serious AEs.
Day 1 to Day 30
Number of Participants Reporting Medically Attended Adverse Events (MAAEs)
Prazo: Day 1 to Month 12
MAAE is defined as unscheduled visit to or from healthcare professional for any reason, including emergency room visits.
Day 1 to Month 12
Number of Participants Reporting Potential immune-mediated disorders (pIMDs)
Prazo: Day 1 to Month 12
pIMDs are a subset of AEs of Special Interest (AESIs) that include autoimmune disorders and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
Day 1 to Month 12
Number of Participants Reporting Hematological and Biochemical Laboratory Abnormalities
Prazo: At Day 1 (pre-vaccination) in Phase 1 groups
At Day 1 (pre-vaccination) in Phase 1 groups
Number of Participants Reporting Hematological and Biochemical Laboratory Abnormalities
Prazo: At Day 8 (post-vaccination) in Phase 1 groups
At Day 8 (post-vaccination) in Phase 1 groups
Number of Participants Reporting Serious Adverse Events (SAEs)
Prazo: Day 1 to study end [Month 24 for OA groups (only the selected formulation group & its comparators) and Month 12 for all other YA groups & OA groups]
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is an abnormal pregnancy outcome, or is a suspected transmission of any infectious agent via an authorized medicinal product.
Day 1 to study end [Month 24 for OA groups (only the selected formulation group & its comparators) and Month 12 for all other YA groups & OA groups]

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Number of participants with hMPV neutralization titers equal to or above (>=) the assay cut-off value
Prazo: At Day 1 (pre-vaccination), Day 8 and Day 31 in OA groups included in both Phase 1 and Phase 2
At Day 1 (pre-vaccination), Day 8 and Day 31 in OA groups included in both Phase 1 and Phase 2
Geometric mean titers (GMTs) of hMPV neutralization titers
Prazo: At Day 1 (pre-vaccination), Day 8 and Day 31 in OA groups included in both Phase 1 and Phase 2
At Day 1 (pre-vaccination), Day 8 and Day 31 in OA groups included in both Phase 1 and Phase 2
Mean geometric increase (MGI) of hMPV neutralization titers
Prazo: At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in OA groups included in both Phase 1 and Phase 2
At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in OA groups included in both Phase 1 and Phase 2
Seroresponse rate (SRR) against hMPV
Prazo: At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in OA groups included in both Phase 1 and Phase 2
SRR is defined as the number of participants having >=4-fold increase post-vaccination in neutralization titers against hMPV.
At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in OA groups included in both Phase 1 and Phase 2
Number of participants with RSV-A neutralization titers >= assay cut-off value
Prazo: At Day 1 (pre-vaccination), Day 8 and Day 31 in OA groups included in both Phase 1 and Phase 2
At Day 1 (pre-vaccination), Day 8 and Day 31 in OA groups included in both Phase 1 and Phase 2
GMTs of RSV-A neutralization titers
Prazo: At Day 1 (pre-vaccination), Day 8 and Day 31 in OA groups included in both Phase 1 and Phase 2
At Day 1 (pre-vaccination), Day 8 and Day 31 in OA groups included in both Phase 1 and Phase 2
MGI of RSV-A neutralization titers
Prazo: At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in OA groups included in both Phase 1 and Phase 2
At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in OA groups included in both Phase 1 and Phase 2
SRR against RSV-A
Prazo: At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in OA groups included in both Phase 1 and Phase 2
SRR is defined as number of participants having >=4-fold-increase post-vaccination in neutralization titers against RSV-A.
At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in OA groups included in both Phase 1 and Phase 2
Number of participants with RSV-B neutralization titers >= assay cut-off value
Prazo: At Day 1 (pre-vaccination), Day 8 and Day 31 in OA groups included in both Phase 1 and Phase 2
At Day 1 (pre-vaccination), Day 8 and Day 31 in OA groups included in both Phase 1 and Phase 2
GMTs of RSV-B neutralization titers
Prazo: At Day 1 (pre-vaccination), Day 8 and Day 31 in OA groups included in both Phase 1 and Phase 2
At Day 1 (pre-vaccination), Day 8 and Day 31 in OA groups included in both Phase 1 and Phase 2
MGI of RSV-B neutralization titers
Prazo: At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in OA groups included in both Phase 1 and Phase 2
At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in OA groups included in both Phase 1 and Phase 2
SRR against RSV-B
Prazo: At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in OA groups included in both Phase 1 and Phase 2
SRR is defined as number of participants having >=4-fold-increase post-vaccination in neutralization titers against RSV-B.
At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in OA groups included in both Phase 1 and Phase 2

Colaboradores e Investigadores

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

Patrocinador

GlaxoSmithKline

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)

5 de junho de 2026

Conclusão Primária (Estimado)

5 de abril de 2029

Conclusão do estudo (Estimado)

5 de abril de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

26 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

26 de maio de 2026

Primeira postagem (Real)

4 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

20 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

19 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 223960
  • 2025-524456-58 (Outro identificador: EU CT Number)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf

Prazo de Compartilhamento de IPD

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.

Critérios de acesso de compartilhamento IPD

Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • CIF
  • CSR

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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