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Safety and Immunogenicity of GlaxoSmithKline Biologicals Meningococcal Group B Vaccine When Administered Concomitantly With GlaxoSmithKline Biologicals MenACWY Conjugate Vaccine to Healthy Infants

14 de junio de 2018 actualizado por: GlaxoSmithKline

A Phase 3b, Open-Label, Randomized, Multicenter Study to Assess the Safety and Immunogenicity of GlaxoSmithKline Biologicals Meningococcal Group B Vaccine When Administered Concomitantly With GlaxoSmithKline Biologicals MenACWY Conjugate Vaccine to Healthy Infants

The purpose of this trial is to evaluate the immunogenicity, the safety and the tolerability of rMenB+OMV NZ and MenACWY vaccines in healthy infants, when concomitantly administered at 3, 5, 7 and 13 months of age, compared to either alone.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

750

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

  • Argentina
      • Buenos Aires, Argentina, C1425EFD
        • GSK Investigational Site
      • Buenos Aires, Argentina, C1425DEM
        • GSK Investigational Site
      • Cordoba, Argentina, X5000JRD
        • GSK Investigational Site
  • México
      • Mexico City, México, 06760
        • GSK Investigational Site
      • Mexico City, México, 04530
        • GSK Investigational Site
      • Mexico City, México, 06400
        • GSK Investigational Site
      • Morelia, México, 58070
        • GSK Investigational Site

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

2 meses a 3 meses (Niño)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. Healthy 3-month old infants (85-119 days, inclusive) at time of Visit 1 whose parents/legal guardians have given written informed consent after the nature of the study has been explained.
  2. Available for all the visits scheduled in the study.
  3. In good health as determined by medical history, physical examination and clinical judgment of the investigator.

Exclusion Criteria:

  1. History of any previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s) at the time of enrollment.
  2. Previous known or suspected disease caused by N. meningitidis.
  3. Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection or colonization.
  4. History of severe allergic reaction after previous vaccinations, or hypersensitivity to any component of the vaccine.

  5. Known or suspected autoimmune disease or impairment/alteration of the immune system resulting from, for ex-ample:

    • Chronic administration of immunosuppressants or other immune-modifying drugs since birth (3 months prior). (For corticosteroids, this means prednisone, or equivalent, ≥ 0.5 mg/kg/day or ≥ 10 mcg/day for children below 2 years. Inhaled and topical steroids are allowed),
    • Immune deficiency disorder, or known HIV infection.
  6. Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation since birth.
  7. History of any progressive or severe neurologic disorder, or seizure disorder or Guillan Barré syndrome (exception: one self-limited febrile seizure is acceptable).
  8. History of any bleeding disorder considered as a contraindication to intramuscular injection or blood draw.
  9. Child's parent(s) or legal guardian(s) are not able to comprehend and to follow all required study procedures for the whole period of the study.
  10. Receipt of any investigational or non-registered product since birth (3 month prior) or are expected to receive during the study period.
  11. Family members or household members of site research staff.
  12. Any clinically-significant chronic or progressive disease according to judgment of the investigator (pulmonary, cardiovascular, renal, hepatic or endocrine functional abnormality) or a congenital anomaly/known cytogenic disorder (e.g., Down's syndrome).
  13. History or any illness/condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the 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: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: rMenB+ACWY
Approximately 250 healthy infants who will be vaccinated at 3, 5, 7 and 13 months of age.
Biológico: Meningococcal group B Vaccine, rMenB+OMV NZ
4 doses administered intramuscularly on Days 1, 61, 121 and 301 with blood draw visits at Days 1, 151, 301 and 331 and who will receive reminder calls at 2 and 4 days after each vaccination visit and safety calls on Days 201 and 251.
Otros nombres:
  • Bexsero®
Biológico: Meningococcal ACWY Conjugate Vaccine, MenACWY
4 doses administered intramuscularly on Days 1, 61, 121 and 301 with blood draw visits at Days 1, 151, 301 and 331 and who will receive reminder calls at 2 and 4 days after each vaccination visit and safety calls on Days 201 and 251.
Otros nombres:
  • Menveo®
Comparador activo: rMENB
Approximately 250 healthy infants who will be vaccinated at 3, 5, 7 and 13 months of age.
Biológico: Meningococcal group B Vaccine, rMenB+OMV NZ
4 doses administered intramuscularly on Days 1, 61, 121 and 301 with blood draw visits at Days 1, 151, 301 and 331 and who will receive reminder calls at 2 and 4 days after each vaccination visit and safety calls on Days 201 and 251.
Otros nombres:
  • Bexsero®
Comparador activo: MenACWY
Approximately 250 healthy infants who will be vaccinated at 3, 5, 7 and 13 months of age.
Biológico: Meningococcal ACWY Conjugate Vaccine, MenACWY
4 doses administered intramuscularly on Days 1, 61, 121 and 301 with blood draw visits at Days 1, 151, 301 and 331 and who will receive reminder calls at 2 and 4 days after each vaccination visit and safety calls on Days 201 and 251.
Otros nombres:
  • Menveo®

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against Each of the Serogroup B Indicator Strains
Periodo de tiempo: At Day 331 (one month after the fourth vaccination)

Human serum bactericidal activity (hSBA) titers against each of the serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 after receiving 4 doses of rMenB+OMV NZ / MenACWY vaccines, concomitantly administered, versus corresponding response in subjects who received rMenB+OMV NZ administered alone, were presented in terms of vaccine group specific geometric mean titers (GMTs).

This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups.
At Day 331 (one month after the fourth vaccination)
hSBA Geometric Mean Titers (GMTs) Against Each of the Serogroups A, C, W-135 and Y
Periodo de tiempo: At Day 331 (one month after the fourth vaccination)

hSBA titers against N. meningitidis serogroups A, C, W-135 and Y after receiving four doses of either rMenB+OMV NZ / MenACWY concomitantly administered versus corresponding response in subjects who received MenACWY administered alone were presented in terms of vaccine group specific GMTs.

This outcome measure applies to only rMenB+ACWY and MenACWY groups as the serogroups A,C,W-135 & Y were assessed only for these two groups.
At Day 331 (one month after the fourth vaccination)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains.
Periodo de tiempo: At Day 1

hSBA GMTs against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 at baseline (Day 1).

This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups.
At Day 1
hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains.
Periodo de tiempo: At Day 151 (one month after the third vaccination)

hSBA GMTs against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 at one month after the third vaccination (Day 151).

This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups.
At Day 151 (one month after the third vaccination)
hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains.
Periodo de tiempo: At Day 301 (before the fourth vaccination)

hSBA GMTs against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 before the fourth vaccination (Day 301).

This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups.
At Day 301 (before the fourth vaccination)
hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains.
Periodo de tiempo: At Day 331 (one month after the fourth vaccination)

hSBA GMTs against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 at one month after the fourth vaccination (Day 331).

This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups.
At Day 331 (one month after the fourth vaccination)
hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y.
Periodo de tiempo: At Day 1

hSBA GMTs against each of the N. meningitidis serogroups A, C, W-135, Y at baseline (Day 1).

This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups A,C,W-135 & Y were assessed only for these two groups.
At Day 1
hSBA Geometric Mean Titers Against Each of the Serogroups A, C, W-135 and Y
Periodo de tiempo: At Day 151 (one month after the third vaccination)

hSBA GMTs against each of the N. meningitidis serogroups A, C, W-135, Y at one month after the third vaccination (Day 151).

This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups A,C,W-135 & Y were assessed only for these two groups.
At Day 151 (one month after the third vaccination)
hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y.
Periodo de tiempo: At Day 301 (before the fourth vaccination)

hSBA GMTs against each of the N. meningitidis serogroups A, C, W-135, Y before the fourth vaccination (Day 301).

This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups A,C,W-135 & Y were assessed only for these two groups.
At Day 301 (before the fourth vaccination)
hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y.
Periodo de tiempo: At Day 331 (one month after the fourth vaccination)

hSBA GMTs against each of the N.meningitidis serogroups A, C, W-135, Y at one month after the fourth vaccination (Day 331).

This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups A,C,W-135 & Y were assessed only for these two groups.
At Day 331 (one month after the fourth vaccination)
Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Indicator Strains
Periodo de tiempo: At Day 1

Percentage of subjects with hSBA titers≥ 1:5 against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 before the first vaccination (Day 1).

This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups.
At Day 1
Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Indicator Strains
Periodo de tiempo: At Day 151 (one month after the third vaccination)

Percentage of subjects with hSBA titers ≥ 1:5 against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 one month after the third vaccination (Day 151).

This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups.
At Day 151 (one month after the third vaccination)
Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Strains.
Periodo de tiempo: At Day 301 (before the fourth vaccination)

Percentage of subjects with hSBA titers ≥ 1:5 against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 before the fourth vaccination (Day 301).

This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups.
At Day 301 (before the fourth vaccination)
Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Strains.
Periodo de tiempo: At Day 331 (One month after the fourth vaccination)

Percentage of subjects with hSBA titers ≥ 1:5 against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 one month after the fourth vaccination (Day 331).

This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups.
At Day 331 (One month after the fourth vaccination)
Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains
Periodo de tiempo: At Day 1

Percentage of subjects with hSBA titers ≥ 1:8 against each of the N. meningitidis serogroup B indicator strains at baseline (Day 1).

This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups.
At Day 1
Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains
Periodo de tiempo: At Day 151 (one month after the third vaccination)

Percentage of subjects with hSBA titers ≥ 1:8 against each of the N. meningitidis serogroup B indicator strains at one month after third vaccination (Day 151).

This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups.
At Day 151 (one month after the third vaccination)
Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains
Periodo de tiempo: At Day 301 (before the fourth vaccination)

Percentage of subjects with hSBA titers ≥ 1:8 against each of the N. meningitidis serogroup B indicator strains before the fourth vaccination (Day 301).

This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups.
At Day 301 (before the fourth vaccination)
Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroup B Indicator Strains
Periodo de tiempo: At Day 331 (one month after the fourth vaccination)

Percentage of subjects with hSBA titers≥ 1:8 against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 at one month after the fourth vaccination (Day 331).

This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups.
At Day 331 (one month after the fourth vaccination)
Percentage of Subjects With hSBA Titers ≥1:4 Against Each of the Serogroups A, C, W-135 and Y
Periodo de tiempo: At Day 1

Percentage of subjects with hSBA titers≥ 1:4 against each of the N. meningitidis serogroups A, C, W-135 and Y before the first vaccination (Day 1).

This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups.
At Day 1
Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y
Periodo de tiempo: At Day 151 (one month after the third vaccination)
Percentage of subjects with hSBA titers≥ 1:4 against each of the N. meningitidis serogroups A, C, W-135 and Y at one month after the third vaccination (Day 151). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups.
At Day 151 (one month after the third vaccination)
Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y
Periodo de tiempo: At Day 301 (before the fourth vaccination)

Percentage of subjects with hSBA titers≥ 1:4 against each of the N. meningitidis serogroups A, C, W-135 and Y before the fourth vaccination (Day 301).

This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups.
At Day 301 (before the fourth vaccination)
Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y
Periodo de tiempo: At Day 331 (one month after the fourth vaccination)
Percentage of subjects with hSBA titers≥ 1:4 against each of the N. meningitidis serogroups A, C, W-135 and Y at one month after the fourth vaccination (Day 331). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups.
At Day 331 (one month after the fourth vaccination)
Within-subject Geometric Mean Ratios (GMRs) Against Each of the Serogroup B Indicator Strains
Periodo de tiempo: At Day 331 (one month after fourth vaccination)
Geometric Mean Ratios(GMRs) of GMTs against each of the serogroup B indicator strains- H44/76, 5/99, N98/254 & M10713 were calculated at one month after the fourth vaccination (Day 331) versus pre fourth vaccination(Day 301).
At Day 331 (one month after fourth vaccination)
Within-subject Geometric Mean Ratios (GMRs) Against Each of Serogroups A, C, W-135 and Y
Periodo de tiempo: At Day 331 (one month after the fourth vaccination)
Geometric Mean Ratios(GMRs) of GMTs against each of the serogroups A,C,W-135 & Y were calculated at one month after the fourth vaccination (Day 331) versus pre fourth vaccination (Day 301).
At Day 331 (one month after the fourth vaccination)
Percentage of Subjects With Four-fold Increases in hSBA Titers Against Each of the Serogroup B Indicator Strains
Periodo de tiempo: At Day 331 (one month after the fourth vaccination)

Percentage of subjects with four-fold increase in hSBA titers against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 at one month after the fourth vaccination (Day 331) over pre-fourth vaccination (Day 301).

This outcome measure applies to only groups rMenB+ACWY and rMenB as the serogroup B indicator strains were assessed only for these two groups.

For serogroup B strains, 4-fold increase in titers was defined as post 4th vaccination titer ≥8 (if pre 4th vaccination titer was <2) or post 4th vaccination titer ≥ 4 x pre 4th vaccination titer (if pre 4th vaccination titer was ≥2).
At Day 331 (one month after the fourth vaccination)
Percentage of Subjects With Four-fold Increases in hSBA Titers Against Each of the Serogroups A, C, W-135 and Y
Periodo de tiempo: At Day 331 (one month after the fourth vaccination)

Percentages of subjects with four-fold increases in hSBA against each of the N. meningitidis serogroups A,C,W & Y at one month after the fourth vaccination (Day 331) over pre-fourth vaccination(Day 301).

This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups.

For serogroups A, C, W and Y, 4-fold increase in titers was defined as post 4th vaccination titer ≥16 (if pre 4th vaccination titer was <4) or post 4th vaccination titer ≥ 4 x pre 4th vaccination titer (if pre 4th vaccination titer was ≥4).
At Day 331 (one month after the fourth vaccination)
Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y
Periodo de tiempo: At Day 1

Percentage of subjects with hSBA titers≥ 1:8 against each of the N. meningitidis serogroups A, C, W-135 and Y at baseline (Day 1).

This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups.
At Day 1
Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y
Periodo de tiempo: At Day 151 (one month before the third vaccination)

Percentage of subjects with hSBA titers≥ 1:8 against each of the N. meningitidis serogroups A, C, W-135 & Y at one month after the third vaccination (Day 151).

This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups.
At Day 151 (one month before the third vaccination)
Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y
Periodo de tiempo: At Day 301 (before the fourth vaccination)
Percentage of subjects with hSBA titers≥ 1:8 against each of the N. meningitidis serogroups A, C, W-135 & Y before the fourth vaccination (Day 301). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups.
At Day 301 (before the fourth vaccination)
Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y
Periodo de tiempo: At Day 331 (one month after the fourth vaccination)

Percentage of subjects with hSBA titers≥ 1:8 against each of the N. meningitidis serogroups A, C, W-135 & Y at one month after the fourth vaccination (Day 331).

This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups.
At Day 331 (one month after the fourth vaccination)
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs)
Periodo de tiempo: From Day 1 (6 hours) to Day 7 after each vaccination (Days 1, 61, 121 and 301)
Number of subjects with solicited local and systemic AEs during the 7 days (including the day of vaccination) after any vaccination
From Day 1 (6 hours) to Day 7 after each vaccination (Days 1, 61, 121 and 301)
Number of Subjects With Unsolicited Adverse Events
Periodo de tiempo: From Day 1 to Day 7 after each vaccination (Days 1, 61, 121 and 301)
An unsolicited adverse event (AE) is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product at any dose that does not necessarily have to have a causal relationship with this treatment.
From Day 1 to Day 7 after each vaccination (Days 1, 61, 121 and 301)
Number of Subjects With SAEs, AEs Leading to Withdrawal and Medically Attended AEs (MAEs)
Periodo de tiempo: Throughout the whole study period (from Day 1 upto Day 331)
A serious adverse event is any untoward medical occurrence that at any dose results in death/ is life threatening/requires prolonged hospitalization/Persistent or significant disability/incapacity/congenital anomaly/or birth defect.
Throughout the whole study period (from Day 1 upto Day 331)

Colaboradores e Investigadores

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

Patrocinador

GlaxoSmithKline

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)

5 de junio de 2014

Finalización primaria (Actual)

14 de octubre de 2016

Finalización del estudio (Actual)

14 de octubre de 2016

Fechas de registro del estudio

Enviado por primera vez

14 de febrero de 2014

Primero enviado que cumplió con los criterios de control de calidad

3 de abril de 2014

Publicado por primera vez (Estimar)

8 de abril de 2014

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de agosto de 2018

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

14 de junio de 2018

Última verificación

1 de enero de 2018

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 205240 (Identificador de registro: JAPIC-CTI)
  • V72_56 (Otro identificador: Novartis)
  • 2016-005117-44 (Número EudraCT)

Información sobre medicamentos y dispositivos, documentos del estudio

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

No

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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