EUCTR2017-000093-11-Outside-EU/EEA进行中（未招募）1 期
A Phase 3b, Open Label, Controlled, Multi-Center, Extension Study to Athe Persistence of Bactericidal Activity at 4 to 7.5 Years After Two Dose Primary Series of GlaxoSmithKline Biologicals Meningococcal B Recombinant Vaccine and the Response to a Third Dose in Adolescents and Young Adult Subjects who Previously Participated in Parent Studies V72_41 (NCT01423084) and V72P10 (NCT00661713), Compared to Naïve Healthy Controls - MENB REC 2ND GEN-041 (V72_75)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 531
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Inclusion Criterion for follow-on subjects:
- •Individuals who participated to Study V72_41 or V72P10 and have completed vaccination with rMenB+OMV NZ according to a 2-dose schedule
- •Inclusion Criterion for naïve subjects:
- •Individuals of 15 through 21 years of age on the day of in-formed consent and assent as applicable (according to the subject's age) for subjects enrolled at sites that participated to Study V72_41.
- •17 through 24 years of age on the day of informed consent and assent as applicable (according to the subject's age) for subjects enrolled at sites that participated to Study V72P10.
- •Inclusion Criteria for all subjects:
- •Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
- •Individuals who can comply with study procedures including follow-up.
- •Males Or Females of non-childbearing potential Or Females of childbearing potential who are using an effective birth control method .
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 122
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 409
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
- •Inclusion Criterion for follow-on subjects:
- •Individuals who participated to Study V72_41 or V72P10 and have completed vaccination with rMenB+OMV NZ according to a 2-dose schedule
- •Inclusion Criterion for naïve subjects:
- •Individuals of 15 through 21 years of age on the day of in-formed consent and assent as applicable (according to the subject's age) for subjects enrolled at sites that participated to Study V72_41.
- •17 through 24 years of age on the day of informed consent and assent as applicable (according to the subject's age) for subjects enrolled at sites that participated to Study V72P10.
- •Inclusion Criteria for all subjects:
- •Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
- •Individuals who can comply with study procedures including follow-up.
- •Males Or Females of non-childbearing potential Or Females of childbearing potential who are using an effective birth control method .
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 122
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 409
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
- •Inclusion Criterion for follow-on subjects:
- •Individuals who participated to Study V72_41 or V72P10 and have completed vaccination with rMenB+OMV NZ according to a 2-dose schedule
- •Inclusion Criterion for naïve subjects:
- •Individuals of 15 through 21 years of age on the day of in-formed consent and assent as applicable (according to the subject's age) for subjects enrolled at sites that participated to Study V72_41.
- •17 through 24 years of age on the day of informed consent and assent as applicable (according to the subject's age) for subjects enrolled at sites that participated to Study V72P10.
- •Inclusion Criteria for all subjects:
- •Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
- •Individuals who can comply with study procedures including follow-up.
- •Males Or Females of non-childbearing potential Or Females of childbearing potential who are using an effective birth control method .
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 122
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 409
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion Criterion for follow-on subjects:
- •Received a third dose of a Meningococcal group B vaccine prior to enrolment in this study.
- •Exclusion Criterion for naïve subjects:
- •Received any other Meningococcal group B vaccines prior to enrolment in this study.
- •Exclusion Criteria for all subjects:
- •Progressive, unstable or uncontrolled clinical conditions.
- •Hypersensitivity, including allergy, to any component of vac-cines or medical equipment whose use is foreseen in this study.
- •Abnormal function of the immune system.
- •Received immunoglobulins or any blood products within 180 days prior to informed consent and assent as applicable (ac-cording to the subject’s age).
- •Received an investigational or non-registered medicinal product within 30 days prior to informed consent and assent as applicable (according to the subject’s age).
- •Study personnel as an immediate family or household mem-ber.
- •Any other clinical condition that, in the opinion of the investi-gator, might pose additional risk to the subject due to partici-pation in the study.
- •Positive results at the urine pregnancy test performed before study vaccination.
- •Exclusion Criterion for follow-on subjects:
- •Received a third dose of a Meningococcal group B vaccine prior to enrolment in this study.
- •Exclusion Criterion for naïve subjects:
- •Received any other Meningococcal group B vaccines prior to enrolment in this study.
- •Exclusion Criteria for all subjects:
- •Progressive, unstable or uncontrolled clinical conditions.
- •Hypersensitivity, including allergy, to any component of vac-cines or medical equipment whose use is foreseen in this study.
- •Abnormal function of the immune system.
- •Received immunoglobulins or any blood products within 180 days prior to informed consent and assent as applicable (ac-cording to the subject’s age).
- •Received an investigational or non-registered medicinal product within 30 days prior to informed consent and assent as applicable (according to the subject’s age).
- •Study personnel as an immediate family or household mem-ber.
- •Any other clinical condition that, in the opinion of the investi-gator, might pose additional risk to the subject due to partici-pation in the study.
- •Positive results at the urine pregnancy test performed before study vaccination.
- •Exclusion Criterion for follow-on subjects:
- •Received a third dose of a Meningococcal group B vaccine prior to enrolment in this study.
- •Exclusion Criterion for naïve subjects:
- •Received any other Meningococcal group B vaccines prior to enrolment in this study.
- •Exclusion Criteria for all subjects:
- •Progressive, unstable or uncontrolled clinical conditions.
- •Hypersensitivity, including allergy, to any component of vac-cines or medical equipment whose use is foreseen in this study.
- •Abnormal function of the immune system.
- •Received immunoglobulins or any blood products within 180 days prior to informed consent and assent as applicable (ac-cording to the subject’s age).
- •Received an investigational or non-registered medicinal product within 30 days prior to informed consent and assent as applicable (according to the subject’s age).
- •Study personnel as an immediate family or household mem-ber.
- •Any other clinical condition that, in the opinion of the investi-gator, might pose additional risk to the subject due to partici-pation in the study.
- •Positive results at the urine pregnancy test performed before study vaccination.
研究者
相似试验
进行中（未招募）
不适用
Study conducted in immunocompromized patients, 2 to 17 years of age, who are at increased risk of acquiring severe meningococcus diasease because of asplenia or deficiencies of the complement system, in comparison with healthy individuals as controls, in order to evaluate safety, tolerability and antibody response after the administration of two doses of the Novartis investigational vaccine directed mainly against Meningococcus serogroup B.Meningococcal Group B disease.MedDRA version: 16.1Level: PTClassification code 10027202Term: Meningitis bacterialSystem Organ Class: 10021881 - Infections and infestationsEUCTR2013-002454-78-ITovartis Vaccines and Diagnostics S.r.l.150
进行中（未招募）
不适用
Study conducted in immunocompromized patients, 2 to 17 years of age, who are at increased risk of acquiring severe meningococcus diasease because of asplenia or deficiencies of the complement system, in comparison with healthy individuals as controls, in order to evaluate safety, tolerability and antibody response after the administration of two doses of the Novartis investigational vaccine directed mainly against Meningococcus serogroup B.Meningococcal Group B disease.MedDRA version: 16.1Level: PTClassification code 10027202Term: Meningitis bacterialSystem Organ Class: 10021881 - Infections and infestationsEUCTR2013-002454-78-ESovartis Vaccines and Diagnostics S.r.l.150
进行中（未招募）
不适用
Study conducted in immunocompromized patients, 2 to 17 years of age, who are at increased risk of acquiring severe meningococcus diasease because of asplenia or deficiencies of the complement system, in comparison with healthy individuals as controls, in order to evaluate safety, tolerability and antibody response after the administration of two doses of the Novartis investigational vaccine directed mainly against Meningococcus serogroup B.EUCTR2013-002454-78-PLovartis Vaccines and Diagnostics S.r.l.150
进行中（未招募）
1 期
Study to assess the safety and immunogenicity of a single dose of GlaxoSmithKline’s (GSK) Meningococcal MenACWY-CRM vaccine (Menveo), administered to subjects 15 through 55 years of age, approximately 4-6 years after primary ACWY vaccination.EUCTR2016-003186-25-Outside-EU/EEAGlaxoSmithKline Biologicals700
进行中（未招募）
不适用
Evaluation of Meningococcal Immune Response Among Children Who Previously Received MenACWY Conjugate VaccineProphylaxis for Neisseria meningitidis serogroup A, C,W-135, and Y.EUCTR2014-005133-30-Outside-EU/EEAovartis Vaccines & Diagnostics, Inc.500