Immunogenicity of GSK Biologicals' Pandemic Influenza Vaccine (GSK1562902A) at Different Boosting Vaccination Schedules
12 de junho de 2018 atualizado por: GlaxoSmithKline
Today, the leading contender for the next influenza pandemic is H5N1, a strain of avian virus found primarily in domestic and wild birds. Experts warn that the next influenza pandemic is imminent and could be severe. Prevention and control will depend on the rapid production and worldwide distribution of specific pandemic vaccines. Candidate 'pandemic-like' vaccines must be developed and tested in clinical trials to determine the best formulation and vaccination schedule.
The purpose of this study is to assess the immune response of a candidate pandemic vaccine. The protocol posting deals with objectives & outcome measures of the secondary phase of this study. The objectives and outcome measures of the primary phase are presented in a separate protocol posting (NCT number = 00449670).
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
845
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
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Singapore, Cingapura, 308433
- GSK Investigational Site
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Singapore, Cingapura, 529889
- GSK Investigational Site
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Hong Kong, Hong Kong
- GSK Investigational Site
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Bangkok, Tailândia, 10700
- GSK Investigational Site
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Taipei, Taiwan, 100
- GSK Investigational Site
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Taipei, Taiwan, 112
- GSK Investigational Site
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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
19 anos a 61 anos (Adulto)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Subjects who completed participation in primary phase of this study.
- Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
- Written informed consent obtained from the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- If the subject is female, she must be of non-childbearing potential or be post-menopausal; if of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after completion of the vaccination series.
Exclusion Criteria:
- Administration of any licensed vaccines within 4 weeks prior to enrolment in this study.
- Planned administration of a vaccine not foreseen by the study protocol: 4 weeks prior to any visit or within 30 days after vaccination.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first visit or planned use during the study
- Any confirmed or suspected immunosuppressive or immunodeficient condition, or autoimmune diseases such as Guillain Barre Syndrome, based on medical history and physical examination (no laboratory testing required).
- History of hypersensitivity to vaccines.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- History of chronic alcohol consumption and/or drug abuse.
- Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first visit or planned use during the study.
- Pregnant or lactating women.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to the first visit, or planned use during the study period.
- Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.
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: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: GSK1562902A M6 Group
Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) and boosted 6 months (M6) after primary vaccination with one dose of Pandemic influenza candidate vaccine (GSK1562902A) in study 109630 (NCT00449670), administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
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IM administration
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Experimental: GSK1562902A M12 Group
Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 12 Months (M12) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
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IM administration
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Experimental: GSK1562902A M36 Group
Healthy male or female adults, primed with 2 doses of adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) in study 109630 (NCT00449670) receiving one dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, at 36 Months (M36) after the primary vaccination, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
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IM administration
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Number of Subjects Boosted at Month 12 With Haemagglutinin-inhibition (HI) Antibody Concentrations Above the Cut-off Value
Prazo: At Month 12 + 21 days
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Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination.
The flu strain assessed was Flu A/Indonesia/05/2005.
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At Month 12 + 21 days
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Titers for Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 12
Prazo: At Month 12 + 21 days
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Titers are presented as geometric mean titers (GMTs).
The reference seropositivity cut-off value was equal to or above (≥) 1:10.
The flu strain assessed was Flu A/Indonesia/05/2005.
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At Month 12 + 21 days
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Number of Subjects Boosted at Month 36 With HI Antibody Concentrations Above the Cut-off Value
Prazo: At Month 36 + 21 days
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Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination.
The flu strain assessed was Flu A/Indonesia/05/2005.
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At Month 36 + 21 days
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Titers for Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 36
Prazo: At Month 36 + 21 days
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Titers are presented as geometric mean titers (GMTs).
The reference seropositivity cut-off value was equal to or above (≥) 1:10.
The flu strain assessed was Flu A/Indonesia/05/2005.
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At Month 36 + 21 days
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Booster Vaccine Response for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 12
Prazo: At Month 12 + 21 days
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Booster vaccine response was defined as: antibody titer after booster vaccination ≥ 4-fold the pre-booster antibody titer.
The Flu strain assessed was A/Indonesia/05/2005 (H5N1).
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At Month 12 + 21 days
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Booster Vaccine Response for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 36
Prazo: At Month 36 + 21 Days
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Booster vaccine response was defined as: antibody titer after booster vaccination ≥ 4-fold the pre-booster antibody titer.
The Flu strain assessed was A/Indonesia/05/2005 (H5N1).
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At Month 36 + 21 Days
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Geometric Mean Fold Rise (GMFR) for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 12
Prazo: At Month 12 + 21 days
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GMFR, also known as seroconversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
The flu strain assessed was Flu A/Indonesia/05/2005.
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At Month 12 + 21 days
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Geometric Mean Fold Rise (GMFR) for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease for Subjects Boosted at Month 36
Prazo: At Month 36 +21 days
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GMFR, also known as seroconversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
The flu strain assessed was Flu A/Indonesia/05/2005.
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At Month 36 +21 days
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Number of Subjects Boosted at Month 12 Seroprotected (SPR) for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease
Prazo: At Month 12 + 21 days
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Seroprotection (SPR) was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:40 against the tested vaccine virus.
The flu strain assessed was Flu A/Indonesia/05/2005.
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At Month 12 + 21 days
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Number of Subjects Boosted at Month 36 Seroprotected (SPR) for HI Antibodies Against A/Indonesia/05/2005 Strain of Influenza Disease
Prazo: At Month 36 + 21 days
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Seroprotection (SPR) was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:40 against the tested vaccine virus.
The flu strain assessed was Flu A/Indonesia/05/2005.
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At Month 36 + 21 days
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Number of Seropositive Subjects for H5N1 HI Antibodies
Prazo: At Months 18, 24, 30 and 36
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Seropositivity was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:10 against the tested vaccine virus.
The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.
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At Months 18, 24, 30 and 36
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Number of Seropositive Subjects for H5N1 HI Antibodies
Prazo: At Months 42 and 48
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Seropositivity was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:10 against the tested vaccine virus.
The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.
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At Months 42 and 48
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Booster Vaccine Response for H5N1 HI Antibodies for Subjects Boosted at Month 6 and Month 12
Prazo: At Months 18, 24 and 30
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Booster vaccine response was defined as: antibody titer after booster vaccination ≥ 4 fold the pre-booster antibody titer.
The Flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.
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At Months 18, 24 and 30
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Number of Subjects Boosted at Month 36 Seroconverted for H5N1 HI Antibodies
Prazo: At Months 18, 24 and 30
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Seroconversion was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post-vaccination reciprocal titer against the vaccine virus.
The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.
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At Months 18, 24 and 30
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Booster Vaccine Response for H5N1 HI Antibodies
Prazo: At Months 36, 42 and 48
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Booster vaccine response was defined as: antibody titer after booster vaccination ≥ 4-fold the pre-booster antibody titer.
The Flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.
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At Months 36, 42 and 48
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Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies
Prazo: At Months 18, 24, 30
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GMFR, also known as seroconversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.
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At Months 18, 24, 30
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Geometric Mean Fold Rise (GMFR) for H5N1 HI Antibodies
Prazo: At Months 36, 42 and 48
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GMFR, also known as seroconversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.
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At Months 36, 42 and 48
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Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies
Prazo: At Months 18, 24 and 30
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Seroprotection (SPR) was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:40 against the tested vaccine virus.
The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.
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At Months 18, 24 and 30
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Number of Seroprotected (SPR) Subjects for H5N1 HI Antibodies
Prazo: At Months 36, 42 and 48
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Seroprotection (SPR) was defined as the proportion of subjects with H5N1 reciprocal HI titers equal to or above (≥) 1:40 against the tested vaccine virus.
The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.
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At Months 36, 42 and 48
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Titers for Serum Neutralizing Antibodies
Prazo: At Months 6/12, 6/12 + 21 days, 24, 36 and 48
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Titers were presented as geometric mean titers (GMTs).
The reference seropositivity cut-off value was equal to or above (≥) 1:28.
The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.
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At Months 6/12, 6/12 + 21 days, 24, 36 and 48
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Booster Vaccine Response for Neutralizing Antibodies
Prazo: At Months 6/12/36 + 21 days, 12, 24, 36 and 48
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Booster vaccine response was defined as: for pre-booster antibody titer < 1:28, antibody titer ≥ 1:56 post-booster; for pre-booster, antibody titer ≥ 1:28, post-booster ≥ 4-fold the pre-booster antibody titer.
The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.
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At Months 6/12/36 + 21 days, 12, 24, 36 and 48
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Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
Prazo: At Months 6/12/36 + 21 days, 12, 24, 36 and 48
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Seropositivity cut-off values assessed were equal to or above (≥) 1:28, ≥ 1:56 and ≥ 1:112 in the sera of subjects seronegative before vaccination.
The flu strain assessed was A/Indonesia/05/2005.
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At Months 6/12/36 + 21 days, 12, 24, 36 and 48
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Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off
Prazo: At Months 6/12/36 + 21 days, 12, 24, 36 and 48
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Seropositivity cut-off values assessed were equal to or above (≥) 1:28, ≥ 1:56 and ≥ 1:112 in the sera of subjects seronegative before vaccination.
The flu strain assessed was A/Vietnam/1194/2004.
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At Months 6/12/36 + 21 days, 12, 24, 36 and 48
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Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Prazo: During the 7-day (Days 0-6) post-vaccination period - subjects boosted at Month 12 and Month 36
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Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling.
Any = occurrence of the symptom regardless of intensity grade.
Grade 3 pain = pain that prevented normal activity.
Grade 3 ecchymosis/induration/redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
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During the 7-day (Days 0-6) post-vaccination period - subjects boosted at Month 12 and Month 36
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Number of Subjects With Any, Grade 3 and Related Solicited General Symptom
Prazo: During the 7-day (Days 0-6) post-vaccination period - subjects boosted at Month 12 and 36
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Assessed solicited general symptoms were arthralgia, fatigue, headache, myalgia, shivering, sweating and fever [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)].
Any = occurrence of the symptom regardless of intensity grade.
Grade 3 symptom = symptom that prevented normal activity.
Grade 3 fever = fever ≥ 39.0 °C.
Related = symptom assessed by the investigator as causally related to the study vaccination.
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During the 7-day (Days 0-6) post-vaccination period - subjects boosted at Month 12 and 36
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Number of Subjects With Adverse Events of Specific Interest (AESIs)
Prazo: During the entire study period (From Month 12 to Month 48)
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An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.
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During the entire study period (From Month 12 to Month 48)
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Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain)
Prazo: At Months 6, 12, 18, 24, 30, 36, 42 and 48 and at Months 6/12/36 + 21 days
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Among cytokines expressed after background reduction were cluster of differentiation 4 all doubles (CD4 all doubles), cluster of differentiation 40-ligand (CD40-L), interferon-gamma (IFN-γ), interleukin-2 (IL-2) and tumour necrosis factor-alpha (TNF-α).
The flu strain assessed was H5N1 A/Indonesia/05/2005.
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At Months 6, 12, 18, 24, 30, 36, 42 and 48 and at Months 6/12/36 + 21 days
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Frequency of Antigen-specific CD4 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain)
Prazo: At Months 6, 12, 18, 24, 30, 36, 42 and 48 and at Months 6/12/36 + 21 days
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Among cytokines expressed after background reduction were cluster of differentiation 4 all doubles (CD4 all doubles), cluster of differentiation 40-ligand (CD40-L), interferon-gamma (IFN-γ), interleukin-2 (IL-2) and tumour necrosis factor-alpha (TNF-α).
The flu strain assessed was H5N1 A/Vietnam/1194/2004.
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At Months 6, 12, 18, 24, 30, 36, 42 and 48 and at Months 6/12/36 + 21 days
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Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Indonesia/05/2005 Strain)
Prazo: At Months 6, 12, 18, 24, 30, 36, 42 and 48 and at Months 6/12/36 + 21 days
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Among cytokines expressed after background reduction were cluster of differentiation 8 all doubles (CD8 all doubles), cluster of differentiation 40-ligand (CD40-L), interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α).
The flu strain assessed was H5N1 A/Indonesia/05/2005.
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At Months 6, 12, 18, 24, 30, 36, 42 and 48 and at Months 6/12/36 + 21 days
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Frequency of Antigen-specific CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines (for A/Vietnam/1194/2004 Strain)
Prazo: At Months 6, 12, 18, 24, 30, 36, 42 and 48 and at Months 6/12/36 + 21 days
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Among cytokines expressed after background reduction were cluster of differentiation 8 all doubles (CD8 all doubles), cluster of differentiation 40-ligand (CD40-L), interferon-gamma (IFN-γ), interleukin-2 (IL-2) and tumour necrosis factor-alpha (TNF-α).
The flu strain assessed was H5N1 A/Vietnam/1194/2004.
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At Months 6, 12, 18, 24, 30, 36, 42 and 48 and at Months 6/12/36 + 21 days
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Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Prazo: During the 30-day (Days 0-29) follow-up period after vaccination
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An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Grade 3 AE = an AE which prevented normal, everyday activities.
Related = AE assessed by the investigator as related to the vaccination.
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During the 30-day (Days 0-29) follow-up period after vaccination
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Number of Subjects With Serious Adverse Events (SAEs)
Prazo: During the entire study period (From Month 12 up to Month 48)
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Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
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During the entire study period (From Month 12 up to Month 48)
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
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.
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 (Real)
23 de março de 2008
Conclusão Primária (Real)
8 de junho de 2011
Conclusão do estudo (Real)
8 de junho de 2011
Datas de inscrição no estudo
Enviado pela primeira vez
21 de março de 2008
Enviado pela primeira vez que atendeu aos critérios de CQ
1 de abril de 2008
Primeira postagem (Estimativa)
4 de abril de 2008
Atualizações de registro de estudo
Última Atualização Postada (Real)
2 de agosto de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
12 de junho de 2018
Última verificação
1 de junho de 2018
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 111443
- 111470
- 111471
- 111472
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
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Relatório de Estudo Clínico
Identificador de informação: 111443Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
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Conjunto de dados de participantes individuais
Identificador de informação: 111443Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 111470 are summarised with studies 111443, 111471, and 111472 on the GSK Clinical Study Register.
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Protocolo de estudo
Identificador de informação: 111443Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
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Especificação do conjunto de dados
Identificador de informação: 111443Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
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Plano de Análise Estatística
Identificador de informação: 111443Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
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Formulário de Consentimento Informado
Identificador de informação: 111443Comentários 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 .