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

NCT ID: NCT02446743

Last Updated: 2018-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 531 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-17
• Study Completion Date: 2016-09-23

Brief Summary

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

Detailed 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.

Conditions

Infections, Meningococcal

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group 3B

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

One dose of the vaccine administered intramuscularly in the deltoid area of the non-dominant arm.

Group B_0_1

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: BIOLOGICAL

One dose of the vaccine administered intramuscularly in the deltoid area of the non-dominant arm.

Interventions

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

One dose of the vaccine administered intramuscularly in the deltoid area of the non-dominant arm.

Intervention Type: BIOLOGICAL

Eligibility 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.

• 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

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.

• 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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Sherwood, Queensland, Australia

GSK Investigational Site

North Adelaide, South Australia, Australia

GSK Investigational Site

Carlton, Victoria, Australia

GSK Investigational Site

Subiaco, Western Australia, Australia

GSK Investigational Site

Truro, Nova Scotia, Canada

GSK Investigational Site

Greater Sudbury, Ontario, Canada

GSK Investigational Site

Newmarket, Ontario, Canada

GSK Investigational Site

Toronto, Ontario, Canada

GSK Investigational Site

Toronto, Ontario, Canada

GSK Investigational Site

Woodstock, Ontario, Canada

GSK Investigational Site

Santiago, , Chile

GSK Investigational Site

Santiago, , Chile

Countries

Australia; Canada; Chile

References

Nolan T, Santolaya ME, de Looze F, Marshall H, Richmond P, Henein S, Rheault P, Heaton K, Perrett KP, Garfield H, Gupta A, Ferguson M, D'Agostino D, Toneatto D, O'Ryan M. Antibody persistence and booster response in adolescents and young adults 4 and 7.5 years after immunization with 4CMenB vaccine. Vaccine. 2019 Feb 21;37(9):1209-1218. doi: 10.1016/j.vaccine.2018.12.059. Epub 2019 Jan 26.

Reference Type: DERIVED

PMID: 30691980 (View on PubMed)

Other Identifiers

V72_75

Identifier Type: OTHER

Identifier Source: secondary_id

2017-000093-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

205218

Identifier Type: -

Identifier Source: org_study_id