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Study to Assess the Immunogenicity and Safety of an Investigational Influenza Vaccine in Children

22 de agosto de 2018 atualizado por: GlaxoSmithKline

Immunogenicity & Safety Study of GSK Biologicals' Thimerosal-free Trivalent Influenza Vaccine (TIV) Versus a Licensed Comparator in Children

The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK1557482A.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

2116

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
      • Birmingham, Alabama, Estados Unidos, 35205
        • GSK Investigational Site
    • Arkansas
      • Benton, Arkansas, Estados Unidos, 72015
        • GSK Investigational Site
    • California
      • Huntington Beach, California, Estados Unidos, 92647
        • GSK Investigational Site
      • Paramount, California, Estados Unidos, 90723
        • GSK Investigational Site
      • West Covina, California, Estados Unidos, 91790
        • GSK Investigational Site
    • Georgia
      • Marietta, Georgia, Estados Unidos, 30062
        • GSK Investigational Site
      • Woodstock, Georgia, Estados Unidos, 30189
        • GSK Investigational Site
    • Illinois
      • DeKalb, Illinois, Estados Unidos, 60115
        • GSK Investigational Site
    • Kansas
      • Newton, Kansas, Estados Unidos, 67114
        • GSK Investigational Site
      • Wichita, Kansas, Estados Unidos, 67207
        • GSK Investigational Site
    • Massachusetts
      • Woburn, Massachusetts, Estados Unidos, 01801
        • GSK Investigational Site
    • Michigan
      • Stevensville, Michigan, Estados Unidos, 49127
        • GSK Investigational Site
    • Missouri
      • Saint Louis, Missouri, Estados Unidos, 63141
        • GSK Investigational Site
    • Nevada
      • Henderson, Nevada, Estados Unidos, 89015
        • GSK Investigational Site
    • New York
      • Cortland, New York, Estados Unidos, 13045
        • GSK Investigational Site
      • Syracuse, New York, Estados Unidos, 13210
        • GSK Investigational Site
    • North Carolina
      • Cary, North Carolina, Estados Unidos, 27518
        • GSK Investigational Site
      • Raleigh, North Carolina, Estados Unidos, 27609
        • GSK Investigational Site
    • Ohio
      • Austintown, Ohio, Estados Unidos, 44515
        • GSK Investigational Site
    • Oregon
      • Albany, Oregon, Estados Unidos, 97322
        • GSK Investigational Site
    • Pennsylvania
      • Erie, Pennsylvania, Estados Unidos, 16505
        • GSK Investigational Site
      • Hermitage, Pennsylvania, Estados Unidos, 16148
        • GSK Investigational Site
    • South Carolina
      • Charleston, South Carolina, Estados Unidos, 29406
        • GSK Investigational Site
    • Texas
      • Austin, Texas, Estados Unidos, 78705
        • GSK Investigational Site
      • Houston, Texas, Estados Unidos, 77055
        • GSK Investigational Site
    • Utah
      • Orem, Utah, Estados Unidos, 84057
        • GSK Investigational Site
      • Provo, Utah, Estados Unidos, 84604
        • GSK Investigational Site
    • Virginia
      • Burke, Virginia, Estados Unidos, 22015
        • GSK Investigational Site

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

3 anos a 17 anos (Filho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Subjects and/or subject parent(s)/Legally Acceptable Representative(s) (LAR) who the investigator believes can and will comply with the requirements of the protocol.
  • A male or female child aged between 3 years and 17 years of age at the time of the first vaccination; children who may or may not have had previous administration of influenza vaccine in a previous season are acceptable.
  • Written informed consent obtained from the subject/from the parent(s)/LAR(s) of the subject.
  • Healthy subjects as established by medical history and history-directed clinical examination before entering into the study.
  • Female subjects of non-childbearing potential may be enrolled in the study.
  • Female subjects of childbearing potential may be enrolled in the study, if the subject:
  • has practiced adequate contraception for 30 days prior to vaccination, and
  • has a negative pregnancy test on the day of vaccination, and
  • has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion Criteria:

  • Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the administration of the study vaccine, or planned use during the study period. Routine, registered childhood vaccinations or registered and recommended pandemic influenza vaccine are not an exclusion.
  • Receipt of a seasonal influenza vaccine outside of this study, during current (2009-2010) flu season.
  • Child in care
  • Receipt of systemic glucocorticoids within 1 month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. Topical, intra-articular or inhaled glucocorticoids are allowed.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • History of hypersensitivity to any vaccine.
  • History of Guillain-Barré-syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
  • Acute disease and/or fever at the time of enrolment.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
  • Pregnant or lactating female.
  • History of chronic alcohol consumption and/or drug abuse.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.

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: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Flulaval Group

subjects received Flulaval™ vaccine according to their priming status and age:

  • 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
  • 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid.
Biológico: GSK investigational vaccine GSK1557482A
One intramuscular injection for primed subjects, two intramuscular injections for unprimed subjects
Comparador Ativo: Fluzone Group

subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:

  • 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
  • 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid.
Biológico: Fluzone®
One intramuscular injection for primed subjects, two intramuscular injections for unprimed subjects

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains.
Prazo: At Day 0 and 28 after last vaccine dose.

The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.

Titers were expressed as geometric mean antibody titers (GMTs).
At Day 0 and 28 after last vaccine dose.
Number of Seroconverted Subjects for HI Antibodies Against the Three Strains.
Prazo: At Day 28 after last vaccine dose.

The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.

Seroconversion was defined as the percentage of vaccinees that had either a pre-vaccination (Day 0) titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.
At Day 28 after last vaccine dose.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata.
Prazo: At Day 0 and 28 after last vaccine dose.

The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.

Titers were expressed as geometric mean antibody titers (GMTs).

Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.
At Day 0 and 28 after last vaccine dose.
Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.
Prazo: At Day 28 after last vaccine dose.

The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.

Seroconversion was defined as the percentage of vaccinees that had either a pre-vaccination (Day 0) titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.

Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.
At Day 28 after last vaccine dose.
Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains.
Prazo: At Day 0 and 28 after last vaccine dose.

The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.

Seroprotection rate (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that represents a putative protective level in adults.
At Day 0 and 28 after last vaccine dose.
Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.
Prazo: At Day 0 and 28 after last vaccine dose.

The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.

Seroprotection rate (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that represents a putative protective level in adults.

Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.
At Day 0 and 28 after last vaccine dose.
Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains.
Prazo: At Day 0 and at Day 28 after last vaccine dose

The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.

Seroconversion factor (SCF) was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination.

Seroconversion factor (SCF) was defined as the geometric mean of the within subjects ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. SCFs were calculated at Day 28 following the complete vaccination regimen.
At Day 0 and at Day 28 after last vaccine dose
Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata.
Prazo: At Day 0 and at Day 28 after last vaccine dose

The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.

Seroconversion factor (SCF) was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination.

Seroconversion factor (SCF) was defined as the geometric mean of the within subjects ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. SCFs were calculated at Day 28 following the complete vaccination regimen.

Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.
At Day 0 and at Day 28 after last vaccine dose
Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).
Prazo: During a 4-day follow-up period (Days 0-3) after vaccination.

The general symptoms solicited from study subjects younger than 5 years of age were drowsiness, irritability, loss of appetite, and fever(= axillary temperature equal to or above 38.0 degrees Celsius (°C)).

Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination.

Grade 3 drowsiness, irritability = symptom that prevented normal activity. Grade 3 loss of appetite = not eating at all.

Grade 3 temperature = axillary temperature ≥ 39.0°C and ≤ 40.0°C.

Related = symptom assessed by the investigator as causally related to the vaccination.
During a 4-day follow-up period (Days 0-3) after vaccination.
Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).
Prazo: During a 4-day follow-up period (Days 0-3) after vaccination.

The general symptoms solicited from study subjects 5 years of age and older were arthralgia (joint pain), fatigue, headache, muscle aches, shivering, and fever(= axillary temperature equal to or above 38.0 degrees Celsius (°C)).

Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination.

Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 temperature = axillary temperature ≥ 39.0°C and ≤ 40.0°C.

Related = symptom assessed by the investigator as causaly related to the vaccination.
During a 4-day follow-up period (Days 0-3) after vaccination.
Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).
Prazo: During a 4-day follow-up period (Days 0-3) after vaccination.

Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited general symptom regardless of intensity grade.

Grade 3 pain = pain that prevented normal activity. Grade 3 redness, swelling = redness, swelling above 100 millimeter (mm). All solicited local AEs were considered to be causally related to vaccination.
During a 4-day follow-up period (Days 0-3) after vaccination.
Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata.
Prazo: During a 4-day follow-up period (Days 0-3) after vaccination.

Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited general symptom regardless of intensity grade.

Grade 3 pain = pain that prevented normal activity. Grade 3 redness, swelling = redness, swelling above 100 millimeter (mm). All solicited local AEs were considered to be causally related to vaccination. Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.
During a 4-day follow-up period (Days 0-3) after vaccination.
Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).
Prazo: During a 28 day follow-up period (Days 0-27) after vaccination.

Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.

Grade 3 = event that prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination.
During a 28 day follow-up period (Days 0-27) after vaccination.
Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs), by Age-strata.
Prazo: During a 28 day follow-up period (Days 0-27) after vaccination.

Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.

Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.

Grade 3 = event that prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination.
During a 28 day follow-up period (Days 0-27) after vaccination.
Number of Subjects Reporting Medically Attended Adverse Events (MAEs).
Prazo: During the entire study period (From Day 0 up to Day 180).
For each solicited and unsolicited symptom the subject experiences, the subject/subject's parent(s)/ Legally Acceptable Representative (LAR(s)) was asked if they received medical attention defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason.
During the entire study period (From Day 0 up to Day 180).
Number of Subjects Reporting Serious Adverse Events (SAEs).
Prazo: During the entire study period (From Day 0 up to Day 180).
An SAE is defined as any untoward medical occurrence in a patient or clinical investigation subject that: results in death, is lifethreatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
During the entire study period (From Day 0 up to Day 180).

Colaboradores e Investigadores

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

Patrocinador

GlaxoSmithKline

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

Links úteis

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

13 de outubro de 2009

Conclusão Primária (Real)

2 de março de 2010

Conclusão do estudo (Real)

17 de junho de 2010

Datas de inscrição no estudo

Enviado pela primeira vez

17 de setembro de 2009

Enviado pela primeira vez que atendeu aos critérios de CQ

17 de setembro de 2009

Primeira postagem (Estimativa)

18 de setembro de 2009

Atualizações de registro de estudo

Última Atualização Postada (Real)

21 de setembro de 2018

Última atualização enviada que atendeu aos critérios de controle de qualidade

22 de agosto de 2018

Última verificação

1 de setembro de 2016

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 112999

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

Sim

Descrição do plano IPD

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Dados/documentos do estudo

  1. Protocolo de estudo
    Identificador de informação: 112999
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  2. Especificação do conjunto de dados
    Identificador de informação: 112999
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  3. Relatório de Estudo Clínico
    Identificador de informação: 112999
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  4. Conjunto de dados de participantes individuais
    Identificador de informação: 112999
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  5. Formulário de Consentimento Informado
    Identificador de informação: 112999
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  6. Plano de Análise Estatística
    Identificador de informação: 112999
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
  7. Formulário de Relato de Caso Anotado
    Identificador de informação: 112999
    Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register

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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