Study to Assess the Immunological Long-term Persistence of Antibodies (Abs) 2 Years After GlaxoSmithKline (GSK) Meningococcal ABCWY Vaccination in the V102_15 (NCT02212457) and Response to a Booster in Adolescents

NCT ID: NCT02946385

Last Updated: 2019-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 604 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-15
• Study Completion Date: 2018-02-13

Brief Summary

The purpose of this study is to compare the persistence of 2 or 3 doses of the GSK MenABCWY vaccine, or 2 doses of GSK rMenB+OMV vaccine (Bexsero) administered to healthy adolescents at approximately 24 months after the last meningococcal vaccination in the parent study V102_15(NCT02212457), compared with baseline antibody levels in vaccine naïve subjects at similar age at enrolment.

Detailed Description

Naive subjects will be randomized 1:1 to receive MenABCWY or rMenB+OMV at Day 1. No randomization to treatment arm for follow-on subjects is required as vaccine groups remain the same as in the parent study V102_15 (NCT02212457).

Response to a booster dose of MenABCWY vaccine will also be assessed in follow-on subjects who received 2 or 3 doses of MenABCWY (at 0.2-, 0,.6- or 0,.2,.6-month schedules) in the parent study, and will be compared with responses to a single dose of MenABCWY in naive subjects (subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study).

Response to a booster dose of GSK Meningococcal B Recombinant vaccine (rMenB+OMV) will be assessed in subjects who received 2 doses of rMenB+OMV (at 0, 2-month schedule) in the parent study, and will be compared with responses to a single dose of rMenB+OMV in naive subjects.

Conditions

Infections, Meningococcal

Study Design

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

Study Groups

ABCWY_ 0_2 Group

Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 2 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study

Group Type: EXPERIMENTAL

Meningococcal ABCWY Vaccine

Intervention Type: BIOLOGICAL

Intramuscular injection of one booster dose at Day 1 to follow-on subjects in the ABCWY\_ 0\_2 Group, ABCWY\_ 0\_2\_6 Group and ABCWY\_ 0\_6 Group, primed with 2 or 3 doses of the study vaccine and 2 doses at Days 1 and 61 to naïve subjects in the ABCWY naïve group.

ABCWY_0_2_6 Group

Subjects who received 3 doses of MenABCWY vaccine at Month 0, Month 2 and Month 6 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study

Group Type: EXPERIMENTAL

Meningococcal ABCWY Vaccine

Intervention Type: BIOLOGICAL

Intramuscular injection of one booster dose at Day 1 to follow-on subjects in the ABCWY\_ 0\_2 Group, ABCWY\_ 0\_2\_6 Group and ABCWY\_ 0\_6 Group, primed with 2 or 3 doses of the study vaccine and 2 doses at Days 1 and 61 to naïve subjects in the ABCWY naïve group.

B_0_2 Group

Subjects who received 2 doses of rMenB+OMV vaccine at Month 0 and Month 2 in study V102\_15 (NCT02212457), and will receive 1 dose of rMenB+OMV in this extension study

Group Type: EXPERIMENTAL

Meningococcal B Recombinant vaccine

Intervention Type: BIOLOGICAL

Intramuscular injection of one booster dose of the rMenB+OMV vaccine to subjects in the B\_0\_2 group, primed with 2 doses of the vaccine and intramuscular injection of 2 doses at Days 1 and 61 in the deltoid area of the non-dominant arm to naïve subjects in the rMenB+OMV Naïve group.

ABCWY_ 0_6 Group

Subjects who received 2 doses of MenABCWY vaccine at Month 0 and Month 6 in study V102\_15 (NCT02212457), and will receive 1 dose of MenABCWY in this extension study

Group Type: EXPERIMENTAL

Meningococcal ABCWY Vaccine

Intervention Type: BIOLOGICAL

Intramuscular injection of one booster dose at Day 1 to follow-on subjects in the ABCWY\_ 0\_2 Group, ABCWY\_ 0\_2\_6 Group and ABCWY\_ 0\_6 Group, primed with 2 or 3 doses of the study vaccine and 2 doses at Days 1 and 61 to naïve subjects in the ABCWY naïve group.

ABCWY Naive Group

Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of MenABCWY in this extension study

Group Type: ACTIVE_COMPARATOR

Meningococcal ABCWY Vaccine

Intervention Type: BIOLOGICAL

Intramuscular injection of one booster dose at Day 1 to follow-on subjects in the ABCWY\_ 0\_2 Group, ABCWY\_ 0\_2\_6 Group and ABCWY\_ 0\_6 Group, primed with 2 or 3 doses of the study vaccine and 2 doses at Days 1 and 61 to naïve subjects in the ABCWY naïve group.

rMenB+OMV Naive Group

Subjects who are meningococcal vaccine-naive and of similar age to subjects enrolled from the parent study (NCT02212457), and will receive 2 doses of rMenB+OMV in this extension study

Group Type: ACTIVE_COMPARATOR

Meningococcal B Recombinant vaccine

Intervention Type: BIOLOGICAL

Intramuscular injection of one booster dose of the rMenB+OMV vaccine to subjects in the B\_0\_2 group, primed with 2 doses of the vaccine and intramuscular injection of 2 doses at Days 1 and 61 in the deltoid area of the non-dominant arm to naïve subjects in the rMenB+OMV Naïve group.

Interventions

Meningococcal ABCWY Vaccine

Intramuscular injection of one booster dose at Day 1 to follow-on subjects in the ABCWY\_ 0\_2 Group, ABCWY\_ 0\_2\_6 Group and ABCWY\_ 0\_6 Group, primed with 2 or 3 doses of the study vaccine and 2 doses at Days 1 and 61 to naïve subjects in the ABCWY naïve group.

Intervention Type: BIOLOGICAL

Meningococcal B Recombinant vaccine

Intramuscular injection of one booster dose of the rMenB+OMV vaccine to subjects in the B\_0\_2 group, primed with 2 doses of the vaccine and intramuscular injection of 2 doses at Days 1 and 61 in the deltoid area of the non-dominant arm to naïve subjects in the rMenB+OMV Naïve group.

Intervention Type: BIOLOGICAL

Other Intervention Names

MenABCWY; rMenB+OMV

Eligibility Criteria

Inclusion Criteria

Follow-on Participants

• Subjects from Finland and Poland previously enrolled in study V102_15 (NCT02212457) who have received all planned meningococcal vaccinations in the study
• Who have not received any additional meningococcal vaccination since the last meningococcal vaccination administered in the parent trial.
• Who have given written informed consent or assent after the nature of the study has been explained according to local regulatory requirements, prior to study entry. If the subject is under age 18 at the time of enrollment, the parent(s)/ legal guardian(s) of the subject should have given their written consent.
• Individuals of who the investigator believes can and will comply with the requirements of the protocol.
• Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.

Naive Group

• Male and female individuals of similar age (approximately 12-20 years) to follow-on subjects from V102_15 (NCT02212457) trial.
• Who have not received any meningococcal vaccination since birth
• Individuals who have given their written informed consent or assent after the nature of the study has been explained according to local regulatory requirements, prior to study entry. If the subject is under age 18 at the time of enrollment, the parent(s)/ legal guardian(s) of the subject should have given their written consent.
• Individuals of who the investigator believes can and will comply with the requirements of the protocol.
• Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.

Exclusion Criteria

Follow-on Participants:

• Follow-on individuals not eligible to be enrolled in the study are those with:
• History of any meningococcal vaccine administration since last meningococcal vaccination administered in V102_15 (NCT02212457) parent study.
• Current or previous, confirmed or suspected disease caused by N. meningitidis, since termination from parent study.
• Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment.
• If the subject is female of childbearing potential, sexually active, and has not used any of the acceptable contraceptive methods for at least 2 months prior to study entry and for the duration of the trial.
• Pregnancy or breast-feeding
• History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component including diphtheria toxoid (CRM197) and latex.
• Progressive, unstable or uncontrolled clinical conditions.
• Any confirmed or suspected condition with impaired/altered function of immune system.
• Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to the study vaccination or planned use throughout the study period. (For corticosteroids, this means prednisone, or equivalent, ≥ 20 mg/day. Inhaled, intranasal and topical steroids are allowed).
• Administration of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the 3 months prior to study enrolment.
• Received an investigational or non-registered medicinal product within 30 days prior to informed consent.
• Administration of any vaccine within 14 days or 28 days prior to enrollment in the study, or within 7 days after vaccination in the study.
• Clinical conditions representing a contraindication to intramuscular vaccination and/or blood draws.
• Who have received systemic antibiotic treatment within 3 days prior to any blood draw
• Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study.

Naive Individuals

• Naive individuals not eligible to be enrolled in the study are those with:
• History of any meningococcal vaccine administration since birth.
• Current or previous, confirmed or suspected disease caused by N. meningitidis.
• Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment.
• If the subject is female of childbearing potential, sexually active, and has not used any of the acceptable contraceptive methods for at least 2 months prior to study entry and for the duration of the trial.
• Pregnancy or breast-feeding.
• History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component including diphtheria toxoid (CRM197) and latex.
• Progressive, unstable or uncontrolled clinical conditions.
• Any confirmed or suspected condition with impaired/altered function of immune system.
• Chronic administration of immunosuppressants or other immune-modifying drugs within 30 days prior to the study enrolment. (For corticosteroids, this means prednisone, or equivalent, ≥ 20 mg/kg/day. Inhaled, intranasal and topical steroids are allowed).
• Administration of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 3 months or planned use throughout the study period.
• Received an investigational or non-registered medicinal product within 30 days prior to informed consent.
• Individuals who are part of study personnel or close family members conducting this study.
• Administration of any vaccine within 14 days or 28 days prior to enrollment in the study, or within 7 days after first vaccination, and/or planned use of any vaccine 7 days prior to and 7 days after second vaccination.
• Clinical conditions representing a contraindication to intramuscular vaccination and/or blood draws.
• Who have received systemic antibiotic treatment within 3 days prior to any blood draw
• Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 20 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

Espoo, , Finland

GSK Investigational Site

Helsinki, , Finland

GSK Investigational Site

Helsinki, , Finland

GSK Investigational Site

Järvenpää, , Finland

GSK Investigational Site

Kokkola, , Finland

GSK Investigational Site

Oulu, , Finland

GSK Investigational Site

Pori, , Finland

GSK Investigational Site

Seinäjoki, , Finland

GSK Investigational Site

Tampere, , Finland

GSK Investigational Site

Turku, , Finland

GSK Investigational Site

Bydgoszcz, , Poland

GSK Investigational Site

Dębica, , Poland

GSK Investigational Site

Gdansk, , Poland

GSK Investigational Site

Gdansk, , Poland

GSK Investigational Site

Lodz, , Poland

GSK Investigational Site

Siemianowice Śląskie, , Poland

GSK Investigational Site

Wroclaw, , Poland

Countries

Finland; Poland

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

V102_15E1

Identifier Type: OTHER

Identifier Source: secondary_id

2016-002230-69

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

205613

Identifier Type: -

Identifier Source: org_study_id