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Safety and Immunogenicity of Three Influenza Vaccines in Children Aged 4 Years Old to Less Than 18 Years Old

2 de noviembre de 2015 actualizado por: Novartis Vaccines

A Phase III, Stratified, Randomized, Double-Blind, Multicenter, Non-Inferiority Study to Evaluate Safety and Immunogenicity of Cell-Based Quadrivalent Subunit Influenza Virus Vaccine and Cell-Based Trivalent Subunit Influenza Virus Vaccines in Subjects Ages ≥4 Years to < 18 Years

Evaluate safety and immunogenicity of three influenza vaccines in children ages greater than 4 years old to less than 18 years old.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

2333

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

  • Estados Unidos
    • Alabama
      • Huntsville, Alabama, Estados Unidos, 35802
      • Mobile, Alabama, Estados Unidos, 36608
    • Arizona
      • Chandler, Arizona, Estados Unidos, 85224
      • Mesa, Arizona, Estados Unidos, 85206
      • Mesa, Arizona, Estados Unidos, 85213
    • Arkansas
      • Harrisburg, Arkansas, Estados Unidos, 72452
      • Jonesboro, Arkansas, Estados Unidos, 72401
    • California
      • Anaheim, California, Estados Unidos, 92804
      • Anaheim, California, Estados Unidos, 92801
      • Downey, California, Estados Unidos, 90241
      • Garden Grove, California, Estados Unidos, 92844
      • Modesto, California, Estados Unidos, 95350
      • Paramount, California, Estados Unidos, 90723
      • Sacramento, California, Estados Unidos, 95816
      • San Diego, California, Estados Unidos, 92103-6204
      • San Francisco, California, Estados Unidos, 94102
      • Santa Rosa, California, Estados Unidos, 95405
      • West Covina, California, Estados Unidos, 91790
    • Colorado
      • Colorado Springs, Colorado, Estados Unidos, 80907
      • Denver, Colorado, Estados Unidos, 80246
      • Denver, Colorado, Estados Unidos, 80249
      • Thornton, Colorado, Estados Unidos, 80233
    • Florida
      • Boca Raton, Florida, Estados Unidos, 33432
      • Lake Mary, Florida, Estados Unidos, 32746
      • Melbourne, Florida, Estados Unidos, 32935
      • Miami Beach, Florida, Estados Unidos, 33141
      • Opa Locka, Florida, Estados Unidos, 33055
      • Pinellas Park, Florida, Estados Unidos, 33781
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30338
      • Marietta, Georgia, Estados Unidos, 30062
      • Woodstock, Georgia, Estados Unidos, 30189
    • Idaho
      • Boise, Idaho, Estados Unidos, 83642
    • Illinois
      • Peoria, Illinois, Estados Unidos, 61602
    • Indiana
      • Mishawaka, Indiana, Estados Unidos, 46545
    • Iowa
      • Council Bluffs, Iowa, Estados Unidos, 51503
    • Kansas
      • Newton, Kansas, Estados Unidos, 67114
      • Wichita, Kansas, Estados Unidos, 67207
      • Wichita, Kansas, Estados Unidos, 67010
    • Kentucky
      • Lexington, Kentucky, Estados Unidos, 40509
      • Louisville, Kentucky, Estados Unidos, 40291
    • Louisiana
      • Metairie, Louisiana, Estados Unidos, 70006
    • Missouri
      • Kansas City, Missouri, Estados Unidos, 64114
      • St. Louis, Missouri, Estados Unidos, 63141
    • Nebraska
      • Bellevue, Nebraska, Estados Unidos, 68005
      • Fremont, Nebraska, Estados Unidos, 68025
      • Omaha, Nebraska, Estados Unidos, 68114
      • Omaha, Nebraska, Estados Unidos, 68134
    • Nevada
      • Las Vegas, Nevada, Estados Unidos, 89104
    • New York
      • Binghamton, New York, Estados Unidos, 13901
    • North Carolina
      • Wilmington, North Carolina, Estados Unidos, 28401
    • Ohio
      • Akron, Ohio, Estados Unidos, 44311
      • Cincinnati, Ohio, Estados Unidos, 45249
      • Cleveland, Ohio, Estados Unidos, 44106
      • Cleveland, Ohio, Estados Unidos, 44122
      • Dayton, Ohio, Estados Unidos, 45414
      • Dayton, Ohio, Estados Unidos, 45406
      • Kettering, Ohio, Estados Unidos, 45429
    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos, 73112
      • Oklahoma City, Oklahoma, Estados Unidos, 73103
      • Tulsa, Oklahoma, Estados Unidos, 74127
    • Pennsylvania
      • Erie, Pennsylvania, Estados Unidos, 16505
      • Erie, Pennsylvania, Estados Unidos, 16508
      • Hermitage, Pennsylvania, Estados Unidos, 16148
      • Sellersville, Pennsylvania, Estados Unidos, 18960
      • Upper St. Clair, Pennsylvania, Estados Unidos, 15241
    • South Carolina
      • Anderson, South Carolina, Estados Unidos, 29621
      • Charleston, South Carolina, Estados Unidos, 29403
      • Mt. Pleasant, South Carolina, Estados Unidos, 29464
    • Tennessee
      • Bristol, Tennessee, Estados Unidos, 37620
      • Jefferson City, Tennessee, Estados Unidos, 37760
      • Lebanon, Tennessee, Estados Unidos, 37087
      • Nashville, Tennessee, Estados Unidos, 37203
    • Texas
      • Austin, Texas, Estados Unidos, 78705
      • Dallas, Texas, Estados Unidos, 75231
      • Fort Worth, Texas, Estados Unidos, 76107
      • Fort Worth, Texas, Estados Unidos, 76135
      • Round Rock, Texas, Estados Unidos, 78681
      • San Angelo, Texas, Estados Unidos, 76904
      • San Antonio, Texas, Estados Unidos, 78229
    • Utah
      • Draper, Utah, Estados Unidos, 84020
      • Layton, Utah, Estados Unidos, 84041
      • Salt Lake City, Utah, Estados Unidos, 84121
      • Salt Lake City, Utah, Estados Unidos, 84109
      • Salt Lake City, Utah, Estados Unidos, 84124
      • South Jordan, Utah, Estados Unidos, 84095
      • West Jordan, Utah, Estados Unidos, 84088
    • Virginia
      • Burke, Virginia, Estados Unidos, 22015
      • Charlottesville, Virginia, Estados Unidos, 22902

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

4 años a 18 años (Niño, Adulto)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. Male or female aged 4 years to less than 18 years of age.
  2. Individual who had a parent or guardian who could give written informed consent after understanding the nature of the study and comply with study procedures and were available for follow-up.
  3. If the individual was of an age where, according to local regulations, informed assent is required, that individual had provided assent to participate in the study.

Exclusion Criteria:

  1. Individuals recently vaccinated against influenza
  2. Subjects with contraindications to receive influenza vaccine

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: QIVc (≥4 to <18 years)
Subjects received one or two doses of QIVc-Quadrivalent Cell-based Influenza Vaccine recommended for 2013-2014 season
Biológico: QIVc
Novartis Investigational Quadrivalent Vaccine
Comparador activo: TIV1c (≥4 to <18 years)
Subjects received one or two doses of TIV1c (Trivalent Inactivated Cell-based Influenza Vaccine containing one strain from B lineage ("B1" strain) recommended for 2013-2014 season
Biológico: TIV1c
Licensed Influenza Vaccine
Comparador activo: TIV2c (≥4 to <18 years)
Subjects received one or two doses of TIV2c (Trivalent Inactivated Cell-based Influenza Vaccine containing B strain from the alternate lineage ("B2" strain) recommended for 2013-2014
Biológico: TIV2c
Novartis Investigational Vaccine

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Geometric Mean Titre (GMT) in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c or TIV2c
Periodo de tiempo: Day 1,Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)

Immunogenicity of QIVc to comparator TIV1c (For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c) was assessed in terms of GMT in subjects (Previously vaccinated and Not previously vaccinated) measured by hemagglutination inhibition (HI) assay, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c.

Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c or TIV2c /GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5.
Day 1,Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c
Periodo de tiempo: Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
Immunogenicity of QIVc to comparator TIVc (For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c) was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase (at least a 4-fold increase in HI titer in subjects seropositive at baseline [i.e., HI titer ≥1:10 at Day 1] ) in HI antibody titers, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c Seroconversion was defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as postvaccination HI titer ≥1:40, and defined in subjects seropositive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer.
Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years
Periodo de tiempo: Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)

Immunogenicity was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase in HI antibody titers, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c Seroconversion was defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as postvaccination HI titer ≥1:40, and defined in subjects seropositive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer.

The Center for Biologics Evaluation, Research, and Review (CBER) criterion for an adult population is that the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40%
Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years
Periodo de tiempo: Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)

Immunogenicity was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing HI titer ≥1:40, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c.

The CBER criterion for adult population was that the lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 70%
Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years
Periodo de tiempo: Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
Immunogenicity was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase in HI antibody titers, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c Seroconversion was defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as postvaccination HI titer ≥1:40, and defined in subjects seropositive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer.
Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years
Periodo de tiempo: Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
Immunogenicity was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing HI titer ≥1:40, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c The Committee for Medicinal Products for Human Use (CHMP) criterion for an adult population was that the percentage of subjects achieving an HI titer ≥1:40 is >70%
Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
Geometric Mean Ratios (GMR) in Subjects After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years Age
Periodo de tiempo: Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
Immunogenicity was measured in subjects (Previously vaccinated and Not previously vaccinated) as the geometric mean ratio (GMR). The ratio of postvaccination to prevaccination HI GMTs, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c .For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c The CHMP criterion for GMR in adult population is >2.5
Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
GMT in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c Against B2 Strain
Periodo de tiempo: Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)

Immunogenicity of QIVc to comparator TIV1c was assessed in terms of GMT in subjects (Previously vaccinated and Not previously vaccinated) measured by HI assay, three weeks after last vaccination with one or two doses of either QIVc or TIV1c.

Superiority was established if the upper bound of the two-sided 95% CI for the ratio of GMTs (GMT TIV1c /GMT QIVc) for HI antibody did not exceed the superiority margin of 1
Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
Percentages of Subjects Achieving Seroconversion Against B2 Strain After One or Two Doses of Either QIVc or TIV1c
Periodo de tiempo: Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)

Immunogenicity of QIVc to comparator TIV1c in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase in HI antibody titers, against influenza strain B2, three weeks after last vaccination with QIVc or TIV1c.

Superiority criterion was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - % seroconversion QIVc) for HI antibody does not exceed the margin of 0 points
Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
GMT in Subjects After Receiving One or Two Doses of Either QIVc,TIV2c Against B1 Strain
Periodo de tiempo: Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)

Immunogenicity of QIVc to comparator TIV2c was assessed in terms of GMT in subjects (Previously vaccinated and Not previously vaccinated) measured by HI assay, three weeks after last vaccination with one or two doses of either QIVc or TIV2c.

Superiority was established if the upper bound of the two-sided 95% CI for the ratio of GMTs (GMT TIV2c /GMT QIVc) for HI antibody does not exceed the superiority margin of 1
Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc or TIV2c
Periodo de tiempo: Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)

Immunogenicity of QIVc to comparator TIV2c in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase in HI antibody titers, against influenza strain B1, three weeks after last vaccination with QIVc or TIV2c.

Superiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV2c - % seroconversion QIVc) for HI antibody does not exceed the margin of 0 points
Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata
Periodo de tiempo: Day 1 to 7 after last vaccination
Safety was assessed in terms of number of subjects (Previously vaccinated and Not previously vaccinated) reporting solicited local and systemic reactions, day 1 to 7 after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c.For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison is between QIVc and TIV2c.
Day 1 to 7 after last vaccination
Number of Subjects Reporting Unsolicited AEs After One or Two Doses of Either QIVc, TIV1c or TIV2c by Overall Age Group
Periodo de tiempo: Day 1 to 210 post vaccination
Safety was assessed in terms of number of subjects (Previously vaccinated and Not previously vaccinated) reporting unsolicited AEs (day 1 to 22 for Previously vaccinated and day 1 to day 50 for Not previously vaccinated subjects), serious adverse events (SAEs), medically attended AEs, AEs leading to withdrawal from the study, new onset of chronic diseases (NOCDs), and concomitant medications (day 1 to day 181 for Previously vaccinated and day 1 to day 210 for Not previously vaccinated subjects) after receiving one or two doses of either QIVc, TIV1c or TIV2c. For A/H1N1, A/H3N2 and B1 strain, the comparison is between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c.
Day 1 to 210 post vaccination

Colaboradores e Investigadores

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

Patrocinador

Novartis Vaccines

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

1 de noviembre de 2013

Finalización primaria (Actual)

1 de agosto de 2014

Finalización del estudio (Actual)

1 de agosto de 2014

Fechas de registro del estudio

Enviado por primera vez

7 de noviembre de 2013

Primero enviado que cumplió con los criterios de control de calidad

18 de noviembre de 2013

Publicado por primera vez (Estimar)

25 de noviembre de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

8 de diciembre de 2015

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

2 de noviembre de 2015

Última verificación

1 de noviembre de 2015

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • V130_03

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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