Combined Study – Phase 3b MenB Long Term Persistence in Adolescents.
- Conditions
- Healthy volunteers (Infections, Meningococcal)Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2017-000093-11-Outside-EU/EEA
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 531
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method