Study to Learn About Safety, Tolerability, and Immune Response of a Catch-up Pneumococcal Vaccine in Children and Adolescents
A PHASE 3, RANDOMIZED DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A CATCH-UP VACCINATION REGIMEN OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY CHILDREN AND ADOLESCENTS
The purpose of this study is to learn about the safety of a new pneumococcal vaccine and how the new pneumococcal vaccine helps to fight against germs that can cause pneumonia (lung infections), meningitis (brain infections), and otitis media (ear infections) in children when compared to the pneumococcal vaccine that is currently in use, 20vPnC (Prevnar 20®).
This study will test if the new pneumococcal vaccine is as safe as the one that is currently in use. It will also assess how the new vaccine works in comparison to the one that is currently in use. To measure how the new pneumococcal vaccine compares to the current one, blood samples will be used to measure the body's ability to create proteins to fight those germs. This new vaccine can possibly provide additional protection against germs that cause pneumococcal disease that are not included in the vaccines that are currently given to children. Pneumococcal disease includes a variety of infections caused by a specific germ, Streptococcus pneumoniae
This study is seeking participants who:
- Are children aged 15 months to 18 years.
- May or may not have received any doses of pneumococcal conjugate vaccine (PCV) in the past.
The study will be conducted in the United States, Puerto Rico, and other countries.
Participants will be assigned to 1 of 3 groups based on age:
Group 1: 15 months to less than 2 years (about 300 participants) Group 2: 2 years to less than 5 years (about 300 participants) Group 3: 5 years to less than 18 years (about 600 participants)
Within each group, participants will be assigned by chance in a 2:1 ratio to receive 1 vaccine injection (shot) with either PG4 (new vaccine) or 20vPnC, given in the arm or thigh. This means that for every 3 participants, about 2 will receive PG4 and about 1 will receive 20vPnC.
Each participant will take part in the study for approximately 6 months. During this time, each participant will visit a clinic 2 times (visit 1 for vaccination and visit 2 to follow up) and will be contacted via telephone once (for a 6 month follow up).
At the study clinic visits, participants will have their blood drawn and be asked if they have experienced any side effects. A side effect is an unintentional or unexpected reaction to a vaccine. During the 6-month follow-up contact, participants will be asked about any further side effects.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 3
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Pfizer CT.gov Call Center
- Número de teléfono: 1-800-718-1021
- Correo electrónico: ClinicalTrials.gov_Inquiries@pfizer.com
Ubicaciones de estudio
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Alabama
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Birmingham, Alabama, Estados Unidos, 35233
- Reclutamiento
- UAB Child Health Research Unit (CHRU)
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Birmingham, Alabama, Estados Unidos, 35205
- Reclutamiento
- Alabama Clinical Therapeutics, LLC Birmingham Pediatric Associates
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Guntersville, Alabama, Estados Unidos, 35976
- Reclutamiento
- Lakeview Clinical Research, LLC
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California
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Fair Oaks, California, Estados Unidos, 95628
- Reclutamiento
- Apex Research Group
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Ontario, California, Estados Unidos, 91762
- Reclutamiento
- Orange County Research Institute
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
- Reclutamiento
- Children's Hospital Colorado
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Florida
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Miami Lakes, Florida, Estados Unidos, 33016
- Reclutamiento
- Indago Research & Health Center, Inc
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Miami Lakes, Florida, Estados Unidos, 33014
- Reclutamiento
- Riveldi and Associates
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Tampa, Florida, Estados Unidos, 33617
- Aún no reclutando
- Children's Health Center
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Idaho
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Ammon, Idaho, Estados Unidos, 83406
- Reclutamiento
- Medical Research Partners
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Blackfoot, Idaho, Estados Unidos, 83221
- Reclutamiento
- Bingham Memorial Hospital
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Boise, Idaho, Estados Unidos, 83702
- Reclutamiento
- ASR, LLC
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Kentucky
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Bardstown, Kentucky, Estados Unidos, 40004
- Reclutamiento
- Kentucky Pediatric/ Adult Research
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Louisiana
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Covington, Louisiana, Estados Unidos, 70433
- Reclutamiento
- Avacare
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Lafayette, Louisiana, Estados Unidos, 70508
- Reclutamiento
- Velocity Clinical Research, Lafayette
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Shreveport, Louisiana, Estados Unidos, 71101
- Reclutamiento
- LSU Health Shreveport Clinical Trials Office
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Shreveport, Louisiana, Estados Unidos, 71101
- Reclutamiento
- Ochsner/LSU Health Shreveport - Progressive Pediatrics
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Shreveport, Louisiana, Estados Unidos, 71103
- Reclutamiento
- Ochsner LSU Health Shreveport Ambulatory Care Center
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Shreveport, Louisiana, Estados Unidos, 71103
- Reclutamiento
- Ochsner/LSU Health Shreveport Academic Medical Center
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Massachusetts
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Fall River, Massachusetts, Estados Unidos, 02721
- Reclutamiento
- Pediatric Associates of Fall River
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Michigan
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Bingham Farms, Michigan, Estados Unidos, 48025
- Reclutamiento
- Michigan Center of Medical Research
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55402
- Reclutamiento
- Clinical Research Institute, Inc.
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Nebraska
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Lincoln, Nebraska, Estados Unidos, 68504
- Reclutamiento
- Midwest Children's Health Research Institute
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Lincoln, Nebraska, Estados Unidos, 68505
- Reclutamiento
- Midwest Children's Health Research Institute
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Lincoln, Nebraska, Estados Unidos, 68516
- Reclutamiento
- Midwest Children's Health Research Institute
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Lincoln, Nebraska, Estados Unidos, 68522
- Reclutamiento
- Midwest Children's Health Research Institute
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New York
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East Syracuse, New York, Estados Unidos, 13057
- Reclutamiento
- Child Health Care Associates
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Horseheads, New York, Estados Unidos, 14845
- Reclutamiento
- Corning Center for Clinical Research
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Rochester, New York, Estados Unidos, 14642
- Reclutamiento
- University of Rochester Medical Center
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45245
- Reclutamiento
- Pediatric Associates of Mt. Carmel
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Cincinnati, Ohio, Estados Unidos, 45206
- Reclutamiento
- Cincinnati Children's Hospital Medical Center Investigational Drug Services
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Cincinnati, Ohio, Estados Unidos, 45206
- Reclutamiento
- Cincinnati Children's Hospital Medical Center Vaccine Research Center
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Dayton, Ohio, Estados Unidos, 45409
- Reclutamiento
- Dayton Clinical Research
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South Euclid, Ohio, Estados Unidos, 44121
- Reclutamiento
- Senders Pediatrics
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South Carolina
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Simpsonville, South Carolina, Estados Unidos, 29681
- Reclutamiento
- Tribe Clinical Research LLC. at Parkside Pediatrics Five Forks
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Tennessee
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Tullahoma, Tennessee, Estados Unidos, 37388
- Reclutamiento
- Pediatric Clinical Trials of Tennessee, LLC
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Texas
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Corpus Christi, Texas, Estados Unidos, 78411
- Reclutamiento
- Driscoll Children's Hosptial
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Houston, Texas, Estados Unidos, 77065
- Reclutamiento
- Kool Kids Pediatrics
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Houston, Texas, Estados Unidos, 77054
- Reclutamiento
- Mercury Clinical Research (Administrative Office)
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Houston, Texas, Estados Unidos, 77077
- Reclutamiento
- Mercury Clinical Research - Sunrise Pediatrics
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Houston, Texas, Estados Unidos, 77402
- Reclutamiento
- Neutra Life Sciences
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Houston, Texas, Estados Unidos, 77054
- Reclutamiento
- Mercury Clinical Research - Administrative Office
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Houston, Texas, Estados Unidos, 77074
- Aún no reclutando
- RTX Clinical Research
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Houston, Texas, Estados Unidos, 77087
- Reclutamiento
- Mercury Clinical Research - MD Kids Pediatrics
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League City, Texas, Estados Unidos, 77573
- Reclutamiento
- University of Texas Medical Branch,
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Lewisville, Texas, Estados Unidos, 75067
- Aún no reclutando
- Prime Clinical Research Inc.
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Mansfield, Texas, Estados Unidos, 76063
- Aún no reclutando
- Prime Clinical Research Inc.
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Richmond, Texas, Estados Unidos, 77469
- Reclutamiento
- Pediatric Center- Neutra Life Sciences
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San Antonio, Texas, Estados Unidos, 78215
- Reclutamiento
- Sun Research Institute
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Victoria, Texas, Estados Unidos, 77901
- Reclutamiento
- Victoria Clinical Research Group
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Utah
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Layton, Utah, Estados Unidos, 84041
- Reclutamiento
- Tanner Clinic
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Layton, Utah, Estados Unidos, 84041
- Reclutamiento
- Tanner Clinic - Layton Parkway
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Provo, Utah, Estados Unidos, 84604
- Reclutamiento
- AMR Clinical
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Syracuse, Utah, Estados Unidos, 84075
- Reclutamiento
- AMR Clinical
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West Jordan, Utah, Estados Unidos, 84088
- Reclutamiento
- Velocity Clinical Research, Salt Lake City
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Virginia
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Charlottesville, Virginia, Estados Unidos, 22902
- Reclutamiento
- Pediatric Research of Charlottesville, LLC
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Richmond, Virginia, Estados Unidos, 23226
- Reclutamiento
- Clinical Research Partners, LLC
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Caguas, Puerto Rico, 00725
- Reclutamiento
- Caguas Clinical Research LLC
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Ponce, Puerto Rico, 00716
- Reclutamiento
- Ponce Medical School Foundation Inc. / CAIMED Center
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San Juan, Puerto Rico, 00907-1509
- Reclutamiento
- BRCR Global Puerto Rico
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San Juan, Puerto Rico, 00918
- Reclutamiento
- CMRC Headlands, LLC
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
Cohort 1 (Participants ≥15 Months to <2 Years of Age) Healthy toddlers and children ≥15 months to <2 years of age with documentation of prior receipt of PCV.
Cohort 2 (Participants ≥2 Years to <5 Years of Age) Healthy toddlers and children ≥2 years to <5 years of age with documentation of prior receipt of PCV if applicable.
Cohort 3 (Participants ≥5 Years to <18 Years of Age) Healthy children ≥5 years to <18 years of age with documentation of prior receipt of PCV (if applicable). A negative urine pregnancy test is required for individuals of childbearing potential (IOCBP). IOCBP or participants able to father must also agree to use a highly effective method of birth control.
Exclusion Criteria:
All Cohorts (Participants ≥15 Months to <18 Years of Age)
Children with significant medical, psychiatric, or neurological conditions (eg, immunodeficiency or history of seizure); or a history of confirmed invasive pneumococcal infection in the past will be excluded from enrolment in the trial
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular)
20-valent pneumococcal conjugate vaccine (20vPnC)
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Vacuna antineumocócica conjugada 20-valente (20vPnC)
Otros nombres:
|
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Experimental: PG4 (intramuscular)
Multivalent Pneumococcal vaccine
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Multivalent Pneumococcal Vaccine
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Periodo de tiempo: Within 7 days after Vaccination
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Within 7 days after Vaccination
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Percentage of Participants With Systemic Events Within 7 Days after Vaccination
Periodo de tiempo: Within 7 days after Vaccination
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Within 7 days after Vaccination
|
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Percentage of Participants With Adverse Events (AEs)
Periodo de tiempo: From Vaccination to 1 month after Vaccination
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From Vaccination to 1 month after Vaccination
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Percentage of Participants With Serious Adverse Events (SAEs)
Periodo de tiempo: From Vaccination to 6 months after Vaccination
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From Vaccination to 6 months after Vaccination
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GMCs of serotype-specific IgG concentrations
Periodo de tiempo: 1 month after vaccination
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1 month after vaccination
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GMTs of serotype-specific OPA titers
Periodo de tiempo: 1 month after vaccination
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1 month after vaccination
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Percentage of participants with predefined serotype-specific IgG concentrations
Periodo de tiempo: 1 month after vaccination
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1 month after vaccination
|
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IgG GMFRs
Periodo de tiempo: 1 month after vaccination
|
1 month after vaccination
|
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Percentage of participants with a ≥4-fold rise in serotype-specific OPA titers
Periodo de tiempo: before to 1 month after vaccination
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before to 1 month after vaccination
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OPA GMFRs
Periodo de tiempo: before to 1 month after vaccination
|
before to 1 month after vaccination
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Pfizer CT.gov Call Center, Pfizer
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- C4931004
- 2025 (Subvención/contrato del NIH de EE. UU.: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- 2025-523445-10-00 (Identificador de registro: CTIS (EU))
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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