NCT02946385

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
604

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2016

Shorter than P25 for phase_2

Geographic Reach
2 countries

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 27, 2016

Completed
19 days until next milestone

Study Start

First participant enrolled

November 15, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2018

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

August 20, 2019

Completed
Last Updated

August 20, 2019

Status Verified

August 1, 2019

Enrollment Period

1.2 years

First QC Date

October 25, 2016

Results QC Date

February 12, 2019

Last Update Submit

August 12, 2019

Conditions

Infections, Meningococcal

Keywords

meningococcal diseasemeningitisboosterantibody persistence

Outcome Measures

Primary Outcomes (2)

  • Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at 24 Months After Last Meningococcal Vaccination in Follow-on Subjects in V102_15 and at Day 1 in Naive Subjects

    The immunogenicity of MenABCWY or rMenB+OMV vaccines, is measured as the percentage of subjects with High-Throughput Human Serum Bactericidal Assay (HT-hSBA) titers greater or equal than (≥) Lower limit of quantification (LLOQ) against N. meningitidis serogroup B test strains and serogroups A,C, W and Y. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab.

    At 24 months after the last meningococcal vaccination for all follow-on subjects and at Day 1 in the extension study for naive subjects

  • hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at 24 Months After Last Meningococcal Vaccination in Follow-on Subjects in V102_15 and at Day 1 in Naive Subjects

    The immunogenicity of MenABCWY or rMenB+OMV vaccines, is measured as the HT-hSBA geometric mean titers (GMTs) against N. meningitidis serogroup B test strains and serogroups A,C, W and Y. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab.

    At 24 months after the last meningococcal vaccination for all follow-on subjects and at Day 1 in the extension study for naive subjects

Secondary Outcomes (17)

  • Percentages of Subjects With HT-hSBA Titers ≥ LLOQ Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at Day 31 After MenABCWY Vaccination in V102_15E1

    Day 31: One month after a booster dose of MenABCWY given at 24 months after last MenABCWY vaccination in groups: ABCWY_0_2, ABCWY_0_6 and ABCWY_0_2_6 and after first dose of MenABCWY in Naive_ABCWY Group

  • Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at Day 31 After MenABCWY Vaccination in V102_15E1

    Day 31: One month after a booster dose of MenABCWY given at 24 months after last MenABCWY vaccination in groups: ABCWY_0_2, ABCWY_0_6 and ABCWY_0_2_6 and after first dose of MenABCWY in Naive_ABCWY Group

  • hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at Day 31 After MenABCWY Vaccination in V102_15E1

    Day 31: One month after a booster dose of MenABCWY given at 24 months after last MenABCWY vaccination in groups: ABCWY_0_2, ABCWY_0_6 and ABCWY_0_2_6 and after first dose of MenABCWY in Naive_ABCWY Group

  • Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains, and N. Meningitidis Serogroups A, C, W and Y at 24 Months At Days 1, 6, 31 in V102_15 Follow-on Subjects and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups

    At Day 1, Day 6 and 31(after booster dose of MenABCWY given at 24 months after last MenABCWY vaccination) in ABCWY_0_2, ABCWY_0_6 and ABCWY_0_2_6 groups and at Day 1, Day 66 and 91(i.e. day 6 and 1 month after dose 2 of MenABCWY) in Naive_ABCWY Group

  • Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y At Days 6, 31 in Follow-on Subjects in V102_15 and at Day 66, 91 in Naive Subjects, in MenABCWY Groups

    At Day 6 and 31(after booster dose of MenABCWY given at 24 months after last MenABCWY vaccination) in ABCWY_0_2, ABCWY_0_6 and ABCWY_0_2_6 groups and at Day 66 and 91(i.e. day 6 and 1 month after dose 2 of MenABCWY) in Naive_ABCWY Group

  • +12 more secondary outcomes

Study Arms (6)

ABCWY_ 0_2 Group

EXPERIMENTAL

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

Biological: Meningococcal ABCWY Vaccine

ABCWY_0_2_6 Group

EXPERIMENTAL

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

Biological: Meningococcal ABCWY Vaccine

B_0_2 Group

EXPERIMENTAL

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

Biological: Meningococcal B Recombinant vaccine

ABCWY_ 0_6 Group

EXPERIMENTAL

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

Biological: Meningococcal ABCWY Vaccine

ABCWY Naive Group

ACTIVE COMPARATOR

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

Biological: Meningococcal ABCWY Vaccine

rMenB+OMV Naive Group

ACTIVE COMPARATOR

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

Biological: Meningococcal B Recombinant vaccine

Interventions

Meningococcal ABCWY VaccineBIOLOGICAL

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.

Also known as: MenABCWY
ABCWY Naive GroupABCWY_ 0_2 GroupABCWY_ 0_6 GroupABCWY_0_2_6 Group
Meningococcal B Recombinant vaccineBIOLOGICAL

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.

Also known as: rMenB+OMV
B_0_2 GrouprMenB+OMV Naive Group

Eligibility Criteria

Age12 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +20 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

GSK Investigational Site

Espoo, 02230, Finland

Location

GSK Investigational Site

Helsinki, 00100, Finland

Location

GSK Investigational Site

Helsinki, 00930, Finland

Location

GSK Investigational Site

Jarvenpaa, 04400, Finland

Location

GSK Investigational Site

Kokkola, 67100, Finland

Location

GSK Investigational Site

Oulu, 90220, Finland

Location

GSK Investigational Site

Pori, 28100, Finland

Location

GSK Investigational Site

Seinäjoki, 60100, Finland

Location

GSK Investigational Site

Tampere, 33100, Finland

Location

GSK Investigational Site

Turku, 20520, Finland

Location

GSK Investigational Site

Bydgoszcz, 85-796, Poland

Location

GSK Investigational Site

Dębica, 39-200, Poland

Location

GSK Investigational Site

Gdansk, 80 542, Poland

Location

GSK Investigational Site

Gdansk, 80-546, Poland

Location

GSK Investigational Site

Lodz, 91 347, Poland

Location

GSK Investigational Site

Siemianowice Śląskie, 41-103, Poland

Location

GSK Investigational Site

Wroclaw, 50-368, Poland

Location

MeSH Terms

Conditions

Meningococcal InfectionsMeningitis

Condition Hierarchy (Ancestors)

Neisseriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsNeuroinflammatory DiseasesNervous System Diseases

Results Point of Contact

Title
GSK Response Center
Organization
GlaxoSmithKline
anand.n.harpalani@gsk.com
866-435-7343

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2016

First Posted

October 27, 2016

Study Start

November 15, 2016

Primary Completion

February 13, 2018

Study Completion

February 13, 2018

Last Updated

August 20, 2019

Results First Posted

August 20, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will share

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Locations

PL(7)FI(10)