Um Estudo Clínico da Nova Vacina Pneumocócica V118C em Crianças (V118C-002)
Um Estudo de Fase 1, Randomizado, Duplo-Cego, Controlado por Comparador Ativo para Avaliar a Segurança, Tolerabilidade e Imunogenicidade de uma Nova Vacina Pneumocócica em Crianças
Researchers are looking for new vaccines to prevent pneumococcal disease, which is any infection in the lungs or other parts of the body that is caused by a type of bacteria called Streptococcus pneumoniae. V118C is a new vaccine designed to help prevent disease from Streptococcus pneumoniae bacteria.
This study will look at V118C in toddlers and infants. The goal of the study is to learn how safe V118C is for children and how well they tolerate it.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Stage 1 of the study will be conducted in toddlers enrolled at 12 through 15 months of age who previously completed a primary 3-dose infant series with a licensed pneumococcal conjugate vaccine (PCV). Stage 2 will be conducted in infants enrolled at approximately 2 months of age, who will receive the 3+1 schedule (3 infant doses followed by a toddler dose).
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 1
Contactos e Locais
Contato de estudo
- Nome: Toll Free Number
- Número de telefone: 1-888-577-8839
- E-mail: Trialsites@msd.com
Locais de estudo
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California
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Madera, California, Estados Unidos, 93637
- Recrutamento
- Madera Family Medical Group ( Site 1004)
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Contato:
- Study Coordinator
- Número de telefone: 559-673-3000
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Florida
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Miami, Florida, Estados Unidos, 33142
- Recrutamento
- Acevedo Clinical Research Associates ( Site 1029)
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Contato:
- Study Coordinator
- Número de telefone: 305-649-8871
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Tampa, Florida, Estados Unidos, 33606
- Recrutamento
- University of South Florida-Department of Pediatrics ( Site 1002)
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Contato:
- Study Coordinator
- Número de telefone: 813-821-8039
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Kansas
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Topeka, Kansas, Estados Unidos, 66604
- Recrutamento
- Cotton O'Neil Research Center ( Site 1039)
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Contato:
- Study Coordinator
- Número de telefone: 785-354-6000
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Kentucky
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Louisville, Kentucky, Estados Unidos, 40202
- Recrutamento
- University of Louisville, Norton Children's Research Institute ( Site 1005)
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Contato:
- Study Coordinator
- Número de telefone: 502-629-5820
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Maryland
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Columbia, Maryland, Estados Unidos, 21045
- Recrutamento
- The Pediatric Center ( Site 1025)
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Contato:
- Study Coordinator
- Número de telefone: 443-721-7224
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Missouri
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St Louis, Missouri, Estados Unidos, 63104
- Recrutamento
- Saint Louis University Center for Vaccine Development ( Site 1031)
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Contato:
- Study Coordinator
- Número de telefone: 314-977-6333
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New York
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East Syracuse, New York, Estados Unidos, 13057
- Recrutamento
- Child Health Care Associates ( Site 1035)
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Contato:
- Study Coordinator
- Número de telefone: 315-652-8800
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29414
- Recrutamento
- Carolina Family Care ( Site 1021)
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Contato:
- Study Coordinator
- Número de telefone: 843-870-2225
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Greenville, South Carolina, Estados Unidos, 29607
- Recrutamento
- Tribe Clinical Research, LLC-Pediatrics ( Site 1008)
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Contato:
- Study Coordinator
- Número de telefone: 864-334-0141
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Spartanburg, South Carolina, Estados Unidos, 29301
- Recrutamento
- Tribe Clinical Research - Spartanburg ( Site 1001)
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Contato:
- Study Coordinator
- Número de telefone: 864-334-0141
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Texas
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Carrollton, Texas, Estados Unidos, 75006
- Recrutamento
- Epic Medical Research - Carrollton ( Site 1038)
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Contato:
- Study Coordinator
- Número de telefone: 972-777-6956
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Garland, Texas, Estados Unidos, 75043
- Recrutamento
- Epic Medical Research- Garland ( Site 1017)
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Contato:
- Study Coordinator
- Número de telefone: 972-777-6956
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League City, Texas, Estados Unidos, 77573
- Recrutamento
- University of Texas Medical Branch ( Site 1020)
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Contato:
- Study Coordinator
- Número de telefone: 832-340-2313
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Virginia
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Charlottesville, Virginia, Estados Unidos, 22902
- Recrutamento
- Pediatric Research of Charlottesville, LLC ( Site 1012)
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Contato:
- Study Coordinator
- Número de telefone: 434-872-9384
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Stage 1:
- Is previously vaccinated with 3 routine infant doses of Pneumococcal 20-valent conjugate vaccine (PCV20)
- Is 12 through 15 months of age
Stage 2:
- Is approximately 2 months of age
Both Stages:
- Was born at full term (gestational age greater than or equal to 37 weeks)
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
Stage 1:
- Has received a PCV dose at 10 months of age and older
Stage 2:
- Has received prior administration of any pneumococcal vaccine
Both stages:
- Has a history of invasive pneumococcal disease (IPD)
- Has a known hypersensitivity to any component of V118C or PCV20 including diphtheria toxoid
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: V118C (Stage 1)
Participants will receive a single 0.5 mL intramuscular (IM) injection of V118C administered at 12 to 15 months of age. |
IM administration of V118C |
|
Experimental: V118C (Stage 2)
Participants will receive a single 0.5 mL IM injection of V118C administered at 2,4,6, and 12 months of age. |
IM administration of V118C |
|
Comparador Ativo: PCV20 (Stage 1)
Participants will receive a single 0.5 mL IM injection of PCV20 administered at 12 to 15 months of age. |
IM administration of PCV20 |
|
Comparador Ativo: PCV20 (Stage 2)
Participants will receive a single 0.5 mL IM injection of PCV20 administered at 2,4,6, and 12 months of age. |
IM administration of PCV20 |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Stage 1: Percentage of Participants With Immediate Adverse Events (AEs) Following Vaccination
Prazo: Up to approximately 30 minutes postvaccination
|
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants with immediate AEs following vaccination will be reported. |
Up to approximately 30 minutes postvaccination
|
|
Stage 1: Percentage of Participants With Solicited Injection-Site Adverse Events (AEs)
Prazo: Up to approximately 7 days postvaccination
|
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A solicited AE is a predefined event that participants legally acceptable representative (LAR) are specifically asked about and record on their electronic vaccine report card (eVRC). Solicited injection-site AEs include redness, swelling, pain or tenderness and hard lump. Percentage of participants with solicited injection-site AEs will be reported. |
Up to approximately 7 days postvaccination
|
|
Stage 1: Percentage of Participants With Solicited Systemic AEs
Prazo: Up to approximately 7 days postvaccination
|
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A solicited AE is a predefined event that participants LAR are specifically asked about and record on their eVRC. Solicited systemic AEs include irritability, drowsiness, appetite lost, hives or welts, and fever. Percentage of participants with solicited systemic AEs will be reported. |
Up to approximately 7 days postvaccination
|
|
Stage 1: Percentage of Participants With Unsolicited Systemic or Injection-Site AEs
Prazo: Up to approximately 28 days postvaccination
|
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE is an event that is not solicited using a eVRC and that is communicated by a participant. Percentage of participants with unsolicited Systemic or Injection-Site AEs will be reported. |
Up to approximately 28 days postvaccination
|
|
Stage 1: Percentage of Participants With Serious Adverse Events (SAEs)
Prazo: Up to approximately 12 months postvaccination
|
A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Percentage of participants with one or more SAEs will be reported. |
Up to approximately 12 months postvaccination
|
|
Stage 1: Percentage of Participants With Medically Attended AEs (MAAEs)
Prazo: Up to approximately 12 months postvaccination
|
A MAAE is defined as an adverse event in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency department visit, office visit, or an urgent care visit with any medical personnel for any reason. Percentage of participants with MAAEs will be reported. |
Up to approximately 12 months postvaccination
|
|
Stage 2: Percentage of Participants With Immediate AEs Following Vaccination
Prazo: Up to approximately 30 minutes after each vaccination
|
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants with immediate AEs following vaccination will be reported. |
Up to approximately 30 minutes after each vaccination
|
|
Stage 2: Percentage of Participants With Solicited Injection-Site AEs
Prazo: Up to approximately 7 days after each vaccination
|
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A solicited AE is a predefined event that participants LAR are specifically asked about and record on their eVRC. Solicited injection-site AEs include redness, swelling, pain or tenderness and hard lump. Percentage of participants with solicited injection-site AEs will be reported. |
Up to approximately 7 days after each vaccination
|
|
Stage 2: Percentage of Participants With Solicited Systemic AEs
Prazo: Up to approximately 7 days after each vaccination
|
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A solicited AE is a predefined event that participants LAR are specifically asked about and record on their eVRC. Solicited systemic AEs include irritability, drowsiness, appetite lost, hives or welts, and fever. Percentage of participants with solicited systemic AEs will be recorded. |
Up to approximately 7 days after each vaccination
|
|
Stage 2: Percentage of Participants With Unsolicited Systemic or Injection-Site AEs
Prazo: Up to approximately 28 days after each vaccination
|
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE is an event that is not solicited using a eVRC and that is communicated by a participant. Percentage of participants with unsolicited Systemic or Injection-Site AEs will be reported. |
Up to approximately 28 days after each vaccination
|
|
Stage 2: Percentage of Participants With SAEs
Prazo: Up to approximately 12 months postdose 4
|
A SAE is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Percentage of participants with one or more SAEs will be reported. |
Up to approximately 12 months postdose 4
|
|
Stage 2: Percentage of Participants With MAAEs
Prazo: Up to approximately 12 months postdose 4
|
A MAAE is defined as an adverse event in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency department visit, office visit, or an urgent care visit with any medical personnel for any reason. Percentage of participants with MAAEs will be reported. |
Up to approximately 12 months postdose 4
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Stage 1: Geometric Mean Concentrations (GMCs) of Serotype-Specific Immunoglobulin G (IgG)
Prazo: Up to approximately 30 days post vaccination
|
The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (Pn ECL) assay. GMCs of Serotype-specific IgG at 30 days postvaccination with V118C and PCV20 will be reported. |
Up to approximately 30 days post vaccination
|
|
Stage 1: Ratio of GMCs of Serotype-Specific IgG of V118C to PCV20 [V118C/PCV20]
Prazo: Approximately Day 30 postvaccination
|
The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (Pn ECL) assay. Ratio of GMCs of serotype-specific IgG of V118C to PCV20 will be reported. |
Approximately Day 30 postvaccination
|
|
Stage 1: Geometric Mean Fold Rises (GMFRs) of Serotype-Specific Immunoglobulin G (IgG)
Prazo: Day 1 (Baseline) and approximately Day 30 postvaccination
|
Geometric mean fold rise (GMFR) is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline. GMFRs of serotype-specific IgG from baseline (Day 1) to Day 30 with V118C and PCV20 for IgG responses will be reported. |
Day 1 (Baseline) and approximately Day 30 postvaccination
|
|
Stage 1: Percentage of Participants With a ≥ 4-fold Rise for Serotype Specific IgG Concentrations
Prazo: Day 1 (Baseline) and approximately Day 30 postvaccination
|
The percentage of participants with ≥4-fold rise from baseline (Day 1) to Day 30 with V118C and PCV20 for IgG responses will be reported. |
Day 1 (Baseline) and approximately Day 30 postvaccination
|
|
Stage 2: Percentage of Participants With IgG ≥0.35 μg/mL (Response Rates) for Serotype Specific IgG Concentrations at 30 Days Postdose 3
Prazo: Up to approximately 30 days postdose 3
|
Percentage of participants with IgG ≥0.35 μg/mL (response rates) for each serotype at 30 days postdose 3 (PD3) with V118C and PCV20 will be reported will be reported. |
Up to approximately 30 days postdose 3
|
|
Stage 2: Percentage of Participants With IgG ≥0.35 μg/mL (Response Rates) for Serotype Specific IgG Concentrations at 30 Days Predose 4
Prazo: Up to approximately 6 months post dose 3
|
Percentage of participants with IgG ≥0.35 μg/mL (response rates) for each serotype at predose 4 (PD4) with V118C and PCV20 will be reported. |
Up to approximately 6 months post dose 3
|
|
Stage 2: Percentage of Participants With IgG ≥0.35 μg/mL (Response Rates) for Serotype Specific IgG Concentrations at 30 Days Postdose 4
Prazo: Up to approximately 30 days postdose 4
|
Percentage of participants with IgG ≥0.35 μg/mL (response rates) for each serotype at 30 days postdose 4 with V118C and PCV20 will be reported. |
Up to approximately 30 days postdose 4
|
|
Stage 2: Difference in the Response Rates [V118C minus PCV20] for Each Serotype at 30 Days Postdose 3
Prazo: Up to approximately 30 days postdose 3
|
Difference in the response rates [V118C minus PCV20] for each serotype at 30 days postdose 3 with V118C and PCV20 will be reported. |
Up to approximately 30 days postdose 3
|
|
Stage 2: Difference in the Response Rates [V118C Minus PCV20] for Each Serotype at 30 Days Postdose 4
Prazo: Up to approximately 30 days postdose 4
|
Difference in the response rates [V118C minus PCV20] for each serotype at 30 days postdose 4 with V118C and PCV20 will be reported. |
Up to approximately 30 days postdose 4
|
|
Stage 2: GMCs of Serotype-Specific IgG at 30 Days Postdose 3
Prazo: Up to approximately 30 days postdose 3
|
The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (Pn ECL) assay. GMCs of serotype-specific IgG at 30 days postdose 3 with V118C and PCV20 will be reported. |
Up to approximately 30 days postdose 3
|
|
Stage 2: GMCs of Serotype-Specific IgG at 30 Days Predose 4
Prazo: Up to approximately 6 months post dose 3
|
The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (Pn ECL) assay. Serotype-specific IgG GMCs at 30 days predose 4 with V118C and PCV20 will be reported. |
Up to approximately 6 months post dose 3
|
|
Stage 2: GMCs of Serotype-Specific IgG at 30 Days Postdose 4
Prazo: Up to approximately 30 days postdose 4
|
The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (Pn ECL) assay. Serotype-specific IgG GMCs at 30 days postdose 4 with V118C and PCV20 will be reported. |
Up to approximately 30 days postdose 4
|
|
Stage 2: Ratio of Serotype-Specific IgG GMCs of V118C to PCV20 [V118C/PCV20] at 30 Days Postdose 3
Prazo: Up to approximately 30 days postdose 3
|
The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (Pn ECL) assay. Ratio of serotype-specific IgG GMCs of V118C to PCV20 [V118C/PCV20] at 30 days postdose 3 will be reported. |
Up to approximately 30 days postdose 3
|
|
Stage 2: Ratio of Serotype-Specific IgG GMCs of V118C to PCV20 [V118C/PCV20] at 30 Days Postdose 4
Prazo: Up to approximately 30 days postdose 4
|
The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (Pn ECL) assay. Ratio of serotype-specific IgG GMCs of V118C to PCV20 [V118C/PCV20] at 30 days postdose 4 will be reported. |
Up to approximately 30 days postdose 4
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Medical Director, Merck Sharp & Dohme LLC
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- V118C-002
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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