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A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Children With Sickle Cell Disease (V114-023/PNEU-SICKLE)

21 de mayo de 2021 actualizado por: Merck Sharp & Dohme LLC

A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Children With Sickle Cell Disease (PNEU-SICKLE)

This study is designed to describe the safety, tolerability, and immunogenicity of V114 in children with sickle cell disease.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

104

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Brasil
      • Salvador, Brasil, 40420-000
        • Hospital Santo Antonio - Obras Sociais Irma Dulce ( Site 0205)
      • Sao Paulo, Brasil, 01221-900
        • Santa Casa de Misericordia de Sao Paulo ( Site 0202)
    • MG
      • Belo Horizonte, MG, Brasil, 30150-221
        • Santa Casa de Misericordia de Belo Horizonte ( Site 0200)
  • Colombia
    • Atlantico
      • Barranquilla, Atlantico, Colombia, 080020
        • Clinica de la Costa Ltda. ( Site 0300)
    • Valle Del Cauca
      • Cali, Valle Del Cauca, Colombia, 760045
        • Centro de Estudios en Infectologia Pediatrica SAS ( Site 0301)
  • Estados Unidos
    • Delaware
      • Wilmington, Delaware, Estados Unidos, 19803
        • Nemours/Alfred I. duPont Hospital for Children ( Site 0113)
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30303
        • Children's Healthcare of Atlanta ( Site 0100)
    • Michigan
      • Detroit, Michigan, Estados Unidos, 48201
        • Children's Hospital of Michigan ( Site 0111)
    • New Jersey
      • Newark, New Jersey, Estados Unidos, 07112
        • Newark Beth Israel Medical Center ( Site 0115)
    • New York
      • Rochester, New York, Estados Unidos, 14642
        • University of Rochester Medical Center ( Site 0105)
    • Ohio
      • Cincinnati, Ohio, Estados Unidos, 45229
        • Cincinnati Children's Hospital Medical Center ( Site 0101)
  • Grecia
      • Athens, Grecia, 115 27
        • Agia Sophia Children s Hospital ( Site 0700)
      • Thessaloniki, Grecia, 546 42
        • Hippokration General Hospital of Thessaloniki ( Site 0701)
  • Italia
      • Genova, Italia, 16132
        • Ospedale San Martino ( Site 0800)
  • Panamá
      • Panama, Panamá, 0816-00383
        • Cevaxin ( Site 0500)
      • Panama, Panamá, 0816-00383
        • Cevaxin ( Site 0502)
  • República Dominicana
      • Santo Domingo, República Dominicana, 10122
        • Clinical Research Republica Dominicana ( Site 0401)
      • Santo Domingo, República Dominicana, 10205
        • Caimed Dominicana S.A.S ( Site 0400)
    • Santo Domingo
      • Distrito Nacional, Santo Domingo, República Dominicana, 10204
        • Fundacion Dominicana de Perinatologia PRO BEBE INC ( Site 0402)

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

5 años a 17 años (Niño)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Documented diagnosis of sickle cell disease in their medical record

  • Female participants: not pregnant or breastfeeding, and at least 1 of the following conditions apply:

    1) not a woman of childbearing potential (WOCBP) as defined in the protocol, or 2) a WOCBP who agrees to follow the contraceptive guidance in the protocol during the treatment period and for at least 6 weeks after the last dose of study vaccine

  • Has a legally acceptable representative who understands the study procedures, alternate treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent/assent.

Exclusion Criteria:

  • History of Invasive Pneumococcal Disease (positive blood culture, positive cerebrospinal fluid culture, or positive culture at another sterile site) or known history of other culture-positive pneumococcal disease within 3 years of Visit 1 (Day 1)
  • Known hypersensitivity to any component of pneumococcal conjugate vaccine (PCV), or any diphtheria toxoid-containing vaccine
  • Known or suspected impairment of immunological function
  • History of congenital or acquired immunodeficiency
  • Documented human immunodeficiency virus (HIV) infection
  • History of autoimmune disease (including but not limited to systemic lupus erythematosus, antiphospholipid syndrome, Behcet's disease, autoimmune thyroid disease, polymyositis and dermatomyositis, scleroderma, or type 1 diabetes mellitus)
  • Known coagulation disorder contraindicating intramuscular vaccination
  • History of malignancy ≤5 years prior to signing informed consent/assent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
  • A WOCBP who has a positive urine or serum pregnancy test before the first vaccination at Visit 1 (Day 1)
  • Received any PCV or pneumococcal polysaccharide vaccine <3 years before Visit 1 (Day 1)
  • Five (5) years of age and has received <3 doses of PCV
  • Receiving immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease. Note: hydroxyurea is permitted
  • Received immunoglobulin within 6 months before receipt of study vaccine
  • Participated in another clinical study of an investigational product within 2 months before the beginning or anytime during the duration of the current clinical study. Participants enrolled in observational studies may be included
  • Recent history (within the last year) of more than 3 inpatient hospitalizations
  • At the time of signing informed consent/assent, is a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence as assessed by the study investigator
  • History or current evidence of any condition, therapy, lab abnormality or other circumstance that might expose the participant to risk by participating in the study, confound the results of the study, or interfere with the participant's participation for the full duration of the study in the opinion of the Investigator
  • Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿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
Experimental: V114
Participants will receive a single 0.5 mL intramuscular (IM) injection of V114 on Day 1.
Biológico: V114
V114 pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose
Comparador activo: Prevnar 13™
Participants will receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1.
Biológico: Prevnar 13™
Prevnar 13™ pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) in each 0.5 ml dose

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Participants With a Solicited Injection-site Adverse Event
Periodo de tiempo: Up to 14 days post-vaccination
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs included injection-site erythema (redness), injection-site induration (hard lump), injection-site pain (tenderness), and injection-site swelling.
Up to 14 days post-vaccination
Percentage of Participants With a Solicited Systemic Adverse Event
Periodo de tiempo: Up to 14 days post-vaccination
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs included arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain), and urticaria (hives or welts).
Up to 14 days post-vaccination
Percentage of Participants With a Vaccine-related Serious Adverse Event
Periodo de tiempo: Up to 6 months post-vaccination
A serious adverse event (SAE) is an AE that results in death, 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. SAEs that were reported by the investigator to be at least possibly related to the study vaccination were summarized.
Up to 6 months post-vaccination
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30
Periodo de tiempo: Day 30
The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay.
Day 30

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30
Periodo de tiempo: Day 30
Sera from participants was used to measure GMT of 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 using the multiplexed opsonophagocytic assay (MOPA).
Day 30
Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30
Periodo de tiempo: Day 1 (Baseline) and Day 30
IgG for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes unique to V114 (22F and 33F) was determined using an electrochemiluminescence assay. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline (Day 1, pre-vaccination).
Day 1 (Baseline) and Day 30
GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30
Periodo de tiempo: Day 1 (Baseline) and Day 30
Activity for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes unique to V114 (22F and 33F) was determined using a MOPA. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline (Day 1, pre-vaccination).
Day 1 (Baseline) and Day 30

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Merck Sharp & Dohme LLC

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

23 de enero de 2019

Finalización primaria (Actual)

8 de junio de 2020

Finalización del estudio (Actual)

8 de junio de 2020

Fechas de registro del estudio

Enviado por primera vez

2 de noviembre de 2018

Primero enviado que cumplió con los criterios de control de calidad

2 de noviembre de 2018

Publicado por primera vez (Actual)

6 de noviembre de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

16 de junio de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

21 de mayo de 2021

Última verificación

1 de mayo de 2021

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • V114-023 (Otro identificador: Merck Protocol Number)
  • 2018-001152-35 (Número EudraCT)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

Sí

Descripción del plan IPD

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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