- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02285777
Assessing the Effectiveness, Immunogenicity and Safety of Meningococcal ABCWY Vaccine Administered to Healthy Adolescents
A Phase 2b, Controlled, Observer-Blind, Multi-Center Study Assessing the Effectiveness, Immunogenicity and Safety of the 3rd Dose of Novartis Meningococcal ABCWY Vaccine Administered to Healthy Adolescents in the U.S.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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Alabama
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Huntsville, Alabama, Estados Unidos, 35802
- GSK Investigational Site
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Arkansas
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Jonesboro, Arkansas, Estados Unidos, 72401
- GSK Investigational Site
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Florida
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Melbourne, Florida, Estados Unidos, 32934
- GSK Investigational Site
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Kansas
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Newton, Kansas, Estados Unidos, 67114
- GSK Investigational Site
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Wichita, Kansas, Estados Unidos, 67207
- GSK Investigational Site
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Kentucky
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Louisville, Kentucky, Estados Unidos, 40207
- GSK Investigational Site
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68134
- GSK Investigational Site
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Ohio
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Cleveland, Ohio, Estados Unidos, 44121
- GSK Investigational Site
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Adolescents who completed V102_16 study and received the study vaccines as assigned in the protocol (either two doses of the MenABCWY or one dose each of MenACWY and Placebo).
Exclusion Criteria:
- Serious, acute, or chronic illnesses. Previous or suspected disease caused by N. meningitidis.
- History of any meningococcal vaccine administration other than vaccination given in the parent V102_16 protocol.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: MenABCWY Group
Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.
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One dose administered intramuscularly in the deltoid area of a non-dominant arm at Month 6 (Visit 1)
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Comparador Ativo: MenACWY Group
Subjects who received 1 dose of placebo and 1 dose of MenACWY vaccine in the parent study and 1 dose of placebo in the current study.
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One dose of placebo administered intramuscularly in the deltoid area of a non-dominant arm at Month 6 (Visit 1)
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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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Percentages of Subjects Without Bactericidal Activity at 1:4 Dilution Against Each US Neisseria Meningitides (N. Meningitidis) Serogroup B Strain at 1 Month After the 3-dose Vaccination Series.
Prazo: At Month 7 (1 month after the 3-dose vaccination series)
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The effectiveness of three doses of MenABCWY vaccine when compared to one dose of MenACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains at 1 month after the 3-dose vaccination series was evaluated in terms of: the combined percentage of subjects without bactericidal activity at 1:4 dilution using the human Serum Bactericidal Assay (hSBA) against each strain in MenABCWY group and MenACWY group.
The data provided is an average of the percentage of subjects without bactericidal activity at 1:4 dilution across all 110 strains.
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At Month 7 (1 month after the 3-dose vaccination series)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Percentages of Subjects Without Bactericidal Activity at 1:4 Dilution Against Each US N. Meningitidis Serogroup B Strain at 4 Months After the 3-dose Vaccination Series.
Prazo: At Month 10 (4 months after the 3-dose vaccination series)
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The effectiveness of three doses of MenABCWY vaccine when compared to one dose of MenACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains at 4 months after the 3-dose vaccination series was evaluated in terms of: the combined percentage of subjects without bactericidal activity at 1:4 dilution using the hSBA against each strain in MenABCWY Group and MenACWY Group.
The data provided is an average of the percentage of subjects without bactericidal activity at 1:4 dilution across all 110 strains.
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At Month 10 (4 months after the 3-dose vaccination series)
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Percentages of Subjects Without Bactericidal Activity at 1:8 Dilution Against Each US N. Meningitidis Serogroup B Strain at 1 and 4 Months After the 3-dose Vaccination Series.
Prazo: At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)
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The effectiveness of three doses of MenABCWY vaccine when compared to one dose of MenACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains at 1 and 4 months after the 3-dose vaccination series were evaluated in terms of: the combined percentage of subjects without bactericidal activity at 1:8 dilution using the hSBA against each strain in MenABCWY Group and MenACWY Group.
The data provided is an average of the percentage of subjects without bactericidal activity at 1:8 dilution across all 110 strains.
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At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)
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Percentages of US N. Meningitidis Serogroup B Strains Killed at 1:4 and 1:8 Dilutions at 1 and 4 Months After the 3-dose Vaccination Series
Prazo: At Month 6 (before the 3-dose vaccination series) and at Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)
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The mean percentage of US N. meningitidis serogroup B strains killed by each subject, at 1:4 and 1:8 dilutions before the 3-dose vaccination series, at Month 6 (PRE) and at 1 and 4 months after the 3-dose vaccination series (Month 7 and Month 10).
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At Month 6 (before the 3-dose vaccination series) and at Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)
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Percentages of Subjects With Enc-hSBA ≥ 1:4 and Enc-hSBA ≥1:8 at 1 and 4 Months After the 3-dose Vaccination Series
Prazo: At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)
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The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY vaccine, in terms of percentages of subjects with enc-hSBA ≥ 1:4 and enc-hSBA ≥ 1:8 against four N. meningitidis serogroup B test strains (M14459, M07-0241084, 96217 and NZ98/254) at 1 and 4 months after the 3-dose vaccination series (Month 7 and Month 10).
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At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)
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HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains
Prazo: At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)
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The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY vaccine, in terms of HT-hSBA GMTs against four N. meningitidis serogroup B test strains (M14459, M07-0241084, 96217 and NZ98/254) after the 3-dose vaccination series.
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At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)
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Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at 1 Month After the 3-dose Vaccination Series.
Prazo: At Month 7 (1 month after the 3-dose vaccination series)
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The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of percentages of subjects with HT-hSBA titers ≥ LLQ against serogroup N. meningitidis B test strains (M14459, M07-0241084, 96217 and NZ98/254), at 1 month after the 3-dose vaccination series.The LLQ cut off values for strains 96217, M07-0241084,M14459 and NZ98/254 were 8.6, 8.9, 8 and 8.2 respectively.
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At Month 7 (1 month after the 3-dose vaccination series)
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Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ LLQ at 4 Months After the 3-dose Vaccination Series
Prazo: At Month 10 (4 months after the 3-dose vaccination series)
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The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of percentages of subjects with HT-hSBA titers ≥ LLQ against serogroup N. meningitidis B test strains (M14459, M07-0241084, 96217 and NZ98/254), at 4 months after the 3-dose vaccination series. The LLQ cut off values for the strains 96217, M07-0241084,M14459 and NZ98/254 were 8.6,8.9, 8 and 8.2 respectively. |
At Month 10 (4 months after the 3-dose vaccination series)
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Percentages of Subjects With a Two-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroup B Test Strains at 1 and 4 Months After the 3-dose Vaccination Series.
Prazo: At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)
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The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a two-fold rise in HT-hSBA titers against the N. meningitidis serogroup B test strains, at 1 and 4 months after the 3-dose vaccination series.
The two-fold titers rise is defined as: a) for subjects with pre-vaccination (month 6 from the parent study) HT-hSBA titers < LLQ, postvaccination HT-hSBA titers ≥ 2 LLQ; b) for subjects with pre-vaccination (month 6 from the parent study) HT-hSBA titers ≥ LLQ, an increase of at least two times the pre-vaccination HT-hSBA titers.
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At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)
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Percentages of Subjects With a Three-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroup B Test Strains at 1 and 4 Months After the 3-dose Vaccination Series.
Prazo: At months 7 and 10 (1 and 4 months after 3-dose vaccination series)
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The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a three-fold rise in HT-hSBA titers against the N. meningitidis serogroup B test strains, at 1 and 4 months after the 3-dose vaccination series.
The three-fold titers rise is defined as: a) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers < LLQ, postvaccination HT-hSBA titers ≥ 3 LLQ; b) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers ≥ LLQ, an increase of at least three times the pre-vaccination HT-hSBA titers.
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At months 7 and 10 (1 and 4 months after 3-dose vaccination series)
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Percentages of Subjects With a Four-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroup B Test Strains at 1 and 4 Months After the 3-dose Vaccination Series.
Prazo: At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)
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The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a four-fold rise in HT-hSBA titers against the N. meningitidis serogroup B test strains, at 1 and 4 months after the 3-dose vaccination series.
The four-fold titers rise is defined as: a) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers < LLQ, postvaccination HT-hSBA titers ≥ 4 LLQ; b) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers ≥ LLQ, an increase of at least four times the pre-vaccination HT-hSBA titers.
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At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)
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HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y.
Prazo: At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)
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The immunogenicity of three doses of MenABCWY compared to a single dose of MenACWY vaccine, in terms of HT-hSBA GMTs to serogroups A, C, W, and Y, at 1 and 4 months after the 3-dose vaccination series.
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At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)
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Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ LLQ at 1 Month After the 3- Dose Vaccination Series
Prazo: At Month 7 (1 month after the 3-dose vaccination series)
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The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers ≥ LLQ against serogroups A, C, W, Y, at 1 month after the 3-dose vaccination series.The LLQ cut off values for serogroups A,C,W and Y were 22.7,5.2,
39.6 and 14.7 respectively.
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At Month 7 (1 month after the 3-dose vaccination series)
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Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ LLQ at 4 Months After the 3-dose Vaccination Series
Prazo: At Month 10 (4 months after the 3-dose vaccination series)
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The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers ≥ LLQ against serogroups A, C, W, Y, at 4 months after the 3-dose vaccination series.
The LLQ cut off values for serogroups A, C, W and Y were 22.7,5.2,39.6 and 14.7 respectively.
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At Month 10 (4 months after the 3-dose vaccination series)
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Percentage of Subjects With Two-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C,W and Y at 1 and 4 Months After the 3-dose Vaccination Series.
Prazo: At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)
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The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a two-fold rise in HT-hSBA titers against the N. meningitidis serogroups A, C, W and Y at 1 and 4 months after the 3-dose vaccination series.
The two-fold titers rise is defined as: a) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers < LLQ, postvaccination HT-hSBA titers ≥ 2 LLQ; b) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers ≥ LLQ, an increase of at least two times the pre-vaccination HT-hSBA titers.
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At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)
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Percentage of Subjects With Three-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C, W and Y at 1 and 4 Months After the 3-dose Vaccination Series.
Prazo: At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)
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The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a three-fold rise in HT-hSBA titers against the N. meningitidis serogroups A, C, W and Y, at 1 and 4 months after the 3-dose vaccination series.
The three-fold titers rise is defined as: a) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers < LLQ, postvaccination HT-hSBA titers ≥ 3 LLQ; b) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers ≥ LLQ, an increase of at least three times the pre-vaccination HT-hSBA titers.
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At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)
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Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C, W and Y at 1 and 4 Months After the 3-dose Vaccination Series.
Prazo: At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)
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The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a four-fold rise in HT-hSBA titers against the N. meningitidis serogroups A, C, W and Y, at 1 and 4 months after the 3-dose vaccination series.
The four-fold titers rise is defined as: a) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers < LLQ, postvaccination HT-hSBA titers ≥ 4 LLQ; b) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers ≥ LLQ, an increase of at least four times the pre-vaccination HT-hSBA titers.
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At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)
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Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series
Prazo: At Month 7 (1 month after the 3-dose vaccination series)
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The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of percentages of subjects with HT-hSBA titers ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 against serogroup N. meningitidis B test strains (M14459, M07-0241084, 96217 and NZ98/254), at 1 month after the 3-dose vaccination series.
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At Month 7 (1 month after the 3-dose vaccination series)
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Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series
Prazo: At Month 10 (4 months after the 3-dose vaccination series)
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The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of percentages of subjects with HT-hSBA titers ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 against serogroup N. meningitidis B test strains (M14459, M07-0241084, 96217 and NZ98/254), at 4 months after the 3-dose vaccination series.
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At Month 10 (4 months after the 3-dose vaccination series)
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Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 1 Month After the 3- Dose Vaccination Series
Prazo: At Month 7 (1 month after the 3-dose vaccination series)
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The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 against serogroups A, C, W, Y, at 1 month after the 3-dose vaccination series.
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At Month 7 (1 month after the 3-dose vaccination series)
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Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 4 Months After the 3-dose Vaccination Series
Prazo: At Month 10 (4 months after the 3-dose vaccination series)
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The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 against serogroups A, C, W, Y, at 4 months after the 3-dose vaccination series.
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At Month 10 (4 months after the 3-dose vaccination series)
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Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs)
Prazo: Day 1 (6 hours) to Day 7 after vaccination
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Number of subjects reporting any solicited local or systemic AEs from Day 1 (6 hours) to Day 7 after any meningococcal vaccination is reported.
Assessed solicited local symptoms were induration, erythema and pain.
Assessed solicited general symptoms were fatigue, myalgia, arthralgia, headache, fever, chills and loss of appetite.
Other solicited data included prevention of pain/fever and treatment of pain/fever.
Any = occurrence of the symptom regardless of intensity grade.
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Day 1 (6 hours) to Day 7 after vaccination
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Number of Subjects Reporting Any Unsolicited AEs
Prazo: Day 1 to Day 30 after any vaccination
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The number of subjects reporting unsolicited AEs after any vaccination is reported.
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.
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Day 1 to Day 30 after any vaccination
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Number of Subjects Reporting Any Serious Adverse Events (SAEs), Medically-attended AEs and AEs Leading to Premature Withdrawal.
Prazo: During the entire study period (from Day 0 up to Month 10)
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The number of subjects reporting any SAEs, medically-attended AEs and AEs leading to premature withdrawal during the entire study period is reported.
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason.
Any was defined as the occurrence of any unsolicited AE regardless of intensitygrade or relation to vaccination.
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During the entire study period (from Day 0 up to Month 10)
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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- Viviani V, Biolchi A, Pizza M. Synergistic activity of antibodies in the multicomponent 4CMenB vaccine. Expert Rev Vaccines. 2022 May;21(5):645-658. doi: 10.1080/14760584.2022.2050697. Epub 2022 Mar 14.
- Welsch JA, Senders S, Essink B, Klein T, Smolenov I, Pedotti P, Barbi S, Verma B, Toneatto D. Breadth of coverage against a panel of 110 invasive disease isolates, immunogenicity and safety for 2 and 3 doses of an investigational MenABCWY vaccine in US adolescents - Results from a randomized, controlled, observer-blind phase II study. Vaccine. 2018 Aug 23;36(35):5309-5317. doi: 10.1016/j.vaccine.2018.07.016. Epub 2018 Jul 27.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 205232
- V102_16E1 (Outro identificador: Novartis Vaccines)
Informações sobre medicamentos e dispositivos, documentos de estudo
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Ensaios clínicos em Meningococcal ABCWY
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GlaxoSmithKlineConcluído