Combined Study - Phase 3b MenB Long Term Persistence in Adolescents

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Infections, Meningococcal

Treatments: Biological: rMenB+OMV NZ (Meningococcal (Group B) multi component recombinant adsorbed vaccine)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02446743

2017-000093-11 (EudraCT Number)

205218

V72_75 (Other Identifier)

Details and patient eligibility

About

The purpose/aim of this study is to assess 1) the long-term persistence (4 to 7.5 years after the last dose) of bactericidal activity following primary vaccination with rMenB+OMV NZ in adolescents [who previously participated in parent studies V72_41 (NCT0142384) and V72P10 (NCT00661713)] and 2) the kinetics of immune response following booster vaccination with rMenB+OMV NZ

Full description

After all subjects (Groups A and B) from Canada and Australia have completed the study, an interim analysis for the primary and secondary immunogenicity objectives will be performed. Follow on subjects (Group A) from parent study V72_41 (NCT0142384) will be analyzed for i) antibody persistence at approximately 4 years following a 2 dose primary series and ii) the immune response at 3, 7 and 30 days after a third dose (booster) of rMenB+OMV NZ. Canadian and Australian vaccine naïve subjects (Group B) will be analyzed for the immune response at 30 days after the first dose, and 3, 7 and 30 days after the second dose of rMenB+OMV NZ.

Subjects in Group B (naïve subjects) will be randomized into two different blood draw schedules according to a 1:1 ratio.

Enrollment: 531 patients

Sex: All

Ages: 15 to 24 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• 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 informed 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 .

Exclusion Criteria for all subjects

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 vaccines 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 (according 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 member.
• Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study.
• Positive results at the urine pregnancy test performed before study vaccination.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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531 participants in 2 patient groups

Group 3B

Experimental group

Description:

Subjects who received a third dose booster of rMenB+OMV NZ at 4 to 7.5 years after the last dose received during studies V72P10 (NCT00661713) or V72_41(NCT0142384), and had blood collected at baseline and at 3, 7 and 30 days after the third dose booster.

Treatment:

Biological: rMenB+OMV NZ (Meningococcal (Group B) multi component recombinant adsorbed vaccine)

Group B_0_1

Active Comparator group

Description:

Subjects who received two doses of rMenB+OMV NZ at a 0 and 1 month schedule and had blood collected at baseline, 30 days after the first dose and 3 or 7, and 30 days after the second dose.

Treatment:

Biological: rMenB+OMV NZ (Meningococcal (Group B) multi component recombinant adsorbed vaccine)