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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 novembro de 2015 atualizado 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

2333

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • 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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

4 anos a 18 anos (Filho, Adulto)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Triplo

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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 Ativo: 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 Ativo: 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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Geometric Mean Titre (GMT) in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c or TIV2c
Prazo: 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
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Novartis Vaccines

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de novembro de 2013

Conclusão Primária (Real)

1 de agosto de 2014

Conclusão do estudo (Real)

1 de agosto de 2014

Datas de inscrição no estudo

Enviado pela primeira vez

7 de novembro de 2013

Enviado pela primeira vez que atendeu aos critérios de CQ

18 de novembro de 2013

Primeira postagem (Estimativa)

25 de novembro de 2013

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

8 de dezembro de 2015

Última atualização enviada que atendeu aos critérios de controle de qualidade

2 de novembro de 2015

Última verificação

1 de novembro de 2015

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • V130_03

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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