Infections, MeningococcalPhase 3NCT02446743

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

A Phase 3 study testing rMenB+OMV NZ (Meningococcal (Group B) multi component recombinant adsorbed vaccine) in people with Infections, Meningococcal, run by GlaxoSmithKline at 12 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 15 to 24 yearsHealthy volunteers can take part
Conditions the study is for: Infections, Meningococcal
What is being tested?: rMenB+OMV NZ (Meningococcal (Group B) multi component recombinant adsorbed vaccine)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 531 participants
Where: 12 sitesin 3 countries
Study dates: 17 Nov 2015to 23 Sep 2016
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 15 to 24 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Individuals who participated to Study V72_41 or V72P10 and have completed vaccination with rMenB+OMV NZ according to a 2-dose schedule
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 .

Who cannot join

Received a third dose of a Meningococcal group B vaccine prior to enrolment in this study.
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).

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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 locations and contacts

12 sites in 3 countries.

Country

City, postcode or hospital

12 sites in 3 countries

Canada6 sites

GSK Investigational Site
Greater Sudbury, Ontario, P3E1H5
GSK Investigational Site
Newmarket, Ontario, L3Y5G8
GSK Investigational Site
Toronto, Ontario, M5G1N8
GSK Investigational Site
Toronto, Ontario, M9V 4B4
GSK Investigational Site
Truro, Nova Scotia, B2N1L2
GSK Investigational Site
Woodstock, Ontario, N4S5P5

Other trials in Canada

Australia4 sites

GSK Investigational Site
Carlton, Victoria, 3010
GSK Investigational Site
North Adelaide, South Australia, 5006
GSK Investigational Site
Sherwood, Queensland, 4075
GSK Investigational Site
Subiaco, Western Australia, 6008

Other trials in Australia

Chile2 sites

GSK Investigational Site
Santiago, 7500092
GSK Investigational Site
Santiago, 8380453

Other trials in Chile

About this study

Official title: A Phase 3b, Open Label, Controlled, Multi-Center, Extension Study to Assess the Persistence of Bactericidal Activity at 4 to 7.5 Years After Two Dose Primary Series of GlaxoSmithKline Biologicals Meningococcal B Recombinant Vaccine and the Response to a Third Dose in Adolescents and Young Adult Subjects Who Previously Participated in Parent Studies V72_41 (NCT01423084) and V72P10 (NCT00661713), Compared to Naïve Healthy Controls

Read the 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
Being tested: rMenB+OMV NZ (Meningococcal (Group B) multi component recombinant adsorbed vaccine)
Keywords: Nervous System Diseases, Meningitis, Central Nervous System Diseases
Medical subject headings: Meningococcal Infections, Nervous System Diseases, Meningitis, Central Nervous System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

rMenB+OMV NZ (Meningococcal (Group B) multi component recombinant adsorbed vaccine)Biological
One dose of the vaccine administered intramuscularly in the deltoid area of the non-dominant arm.

Study groups in NCT02446743
Study group	Role	What they receive
Group 3B	Experimental	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. Receives: Biological: rMenB+OMV NZ (Meningococcal (Group B) multi component recombinant adsorbed vaccine)
Group B_0_1	Active comparator	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. Receives: Biological: rMenB+OMV NZ (Meningococcal (Group B) multi component recombinant adsorbed vaccine)

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Subjects With Human Serum Bactericidal Activity (hSBA)≥1:4
Bactericidal activity was measured against the N. meningitidis group B indicator strains 5/99 and NZ98/254. This outcome measure was assessed only for strains 5/99 and NZ98/254.
Measured: Group 3B: Day 1 (prior to booster dose); Group B_0_1: Day 1 (prior to first dose).
Percentage of Subjects With hSBA≥1:5
Bactericidal activity was measured against the N. meningitidis group B indicator strains H44/76 and M10713. This outcome measure was assessed only for strains H44/76 and M10713.
Measured: Group 3B: Day 1 (prior to booster dose); Group B_0_1: Day 1 (prior to first dose).
Percentage of Subjects With hSBA Titers≥1:5 in Parent Studies-V72P10 and V72_41
Bactericidal activity was measured against the N. meningitidis group B indicator strains H44/76 and M10713
Measured: At one month after last vaccination in parent studies- V72P10 (Month 7) and V72_41 (Month 2)
Percentage of Subjects With hSBA≥1:8
Bactericidal activity was measured against each of the N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713
Measured: Group 3B: Day 1 (prior to booster dose); Group B_0_1: Day 1 (prior to first dose).
Percentage of Subjects With hSBA≥1:16
Bactericidal activity was measured against each of the N. meningitidis group B Indicator strains H44/76,5/99,NZ98/254 and M10713
Measured: Group 3B: Day 1 (prior to booster dose); Group B_0_1: Day 1 (prior to first dose).
hSBA Geometric Mean Titers (GMTs) After the Last Dose of rMenB+OMV NZ Vaccination in the Parent Study.
Bactericidal activity was measured against each of the N. meningitidis group B indicator strains H44/76,5/99, NZ98/254 a nd M10713.
Measured: Group 3B: 1 month after the last rMenB+OMV NZ vaccination in parent study and Day 1(prior to booster dose); Group B_0_1: Day 1(prior to first dose)
Geometric Mean Ratios (GMRs) of GMTs After the Last Dose of rMenB+OMV NZ Vaccination in the Parent Study Versus Day 1.
The GMRs of GMTs at Day 1 versus one month after the last dose of rMenB+OMV NZ vaccination in the parent study were calculated. Bactericidal activity was measured against each of the N. meningitidis group B indicator strains H44/76, 5/99,NZ98/254 and M10713.
Measured: Group 3B: 1 month after the last vaccination in parent study and Day 1 (prior to booster dose)
Number of Subjects With Solicited Local and Systemic AEs.
Solicited adverse events are signs and symptoms derived from organized data collection systems, such as Subject Diaries or interview. The percentage and frequencies of subjects reporting solicited local and systemic AEs were tabulated. Threshold for any Erythema, Swelling and Induration: >= 25 mm Note:Vaccination 2 was performed only on group B_0_1 subjects. Threshold for any Erythema, Swelling and Induration: >= 25 mm
Measured: 7 days (including the day of vaccination) after each vaccination
Number of Subjects With Any Unsolicited Adverse Events (AEs).
An unsolicited adverse event is an adverse event that was not solicited using a subject Diary and that was spontaneously communicated by a subject and/or parent(s)/legal guardian(s) who has signed the informed consent. Note : Vaccination 2 was performed only on group B_0_1 subjects.
Measured: 30 days (including the day of vaccination) after each vaccination.
Number of Subjects With Any SAEs, AEs Leading to Withdrawal and Medically Attended AEs.
A serious adverse event is any untoward medical occurrence that at any dose results in death or is life threatening or requires prolonged hospitalization, leads to Persistent or significant disability/incapacity.
Measured: Group 3B: from Day 1 to Day 31 (study termination visit) and Group B_0_1: from Day 1 to Day 61 (study termination visit)

Secondary outcomes (21)

Percentage of Subjects With hSBA ≥1:4 After Booster Dose/First Vaccination of rMenB+OMV NZ.
Bactericidal activity was measured against the N. meningitidis group B indicator strains 5/99 and NZ98/254. This outcome measure was assessed only for strains 5/99 and NZ98/254.
Measured: Group 3B: 30 days after booster dose, Group B_0_1 : 30 days after first vaccination.
Percentage of Subjects With hSBA ≥1:5 After Booster Dose/First Vaccination of rMenB+OMV NZ.
Bactericidal activity was measured against the N. meningitidis group B indicator strains H44/76 and M10713. This outcome measure was assessed only for strains H44/76 and M10713.
Measured: Group 3B: 30 days after booster dose, Group B_0_1 : 30 days after first vaccination.
Percentage of Subjects With hSBA ≥1:8 After Booster Dose/First Vaccination of rMenB+OMV NZ
Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713.
Measured: Group 3B : 30 days after booster dose, Group B_0_1 : 30 days after first vaccination.
Percentage of Subjects With hSBA ≥1:16 After Booster Dose/First Vaccination of rMenB+OMV NZ
Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76, 5/99, NZ98/254 \& M10713.
Measured: Group 3B: 30 days after booster dose, Group B_0_1 : 30 days after first vaccination.
hSBA Geometric Mean Titers Prior to Booster/First Dose of Vaccination & Post Booster/First Dose of Vaccination.
Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76, 5/99,NZ98/254 and M10713.
Measured: Group 3B subjects: Day 1(pre-booster dose) and 30 days post-booster dose. Group B_0_1: Day 1 (pre-first dose) and 30 days post-first dose.
Geometric Mean Ratio (GMRs) of GMTs After Booster Dose/First rMenB+OMV NZ Vaccination Versus Day 1.
Bactericidal activity was measured against each of the fout N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713 by calculating the GMRs of GMTs one month post-vaccination of a booster dose versus pre-booster dose (follow-on subjects) or first dose of rMenB+OMV NZ versus prefirst dose (naïve subjects) to each N. meningitidis group B indicator strain.
Measured: At Day 31 (30 days post booster dose/first dose of vaccination) versus Day 1 (prior to booster dose/first dose of vaccination).
Percentages of Subjects With at Least 4-fold Increase in hSBA Titers Pre Vaccination Compared to One Month Post-booster/First rMenB+OMV NZ Vaccination
The percentage of subjects with 4-fold rise at one month post-vaccination with a booster dose (follow-on subjects) /first dose (naive subjects) of rMenB+OMV NZ with respect to day 1 (follow-on subjects) / pre-first dose of rMenB+OMV NZ (naïve subjects). Percentage of subjects with four-fold rise in hSBA titers relative to baseline were defined as: • for a pre-vaccination titer < 4, a post-vaccination titer of at least 16; • for a pre-vaccination titer ≥ 4 but <LLOQ, a post vaccination titer of at least fourfold the LLOQ; • for a pre-vaccination titer ≥LLOQ, a post vaccination titer of at least fourfold the pre-vaccination titer
Measured: Group 3B: 1 month after booster dose; Group B_0_1: 1 month after first vaccination
Percentage of Subjects With hSBA ≥1:4 After Booster Dose/Second Vaccination of rMenB+OMV NZ
Bactericidal activity was measured against the N. meningitidis group B indicator strains 5/99 and NZ98/254. On day 1, subjects in the Group B_0_1 were to be randomized into 2 different blood draw schedules according to a 1:1 ratio : 2 blood samples at different time points:
Group B_0_1_1: blood draws at 3 and 30 days after the second dose. Group B_0_1_2: blood draws at 7 and 30 days after the second dose.
This outcome measure was assessed only for strains 5/99 and NZ98/254.
Measured: Group 3B: 3, 7 and 30 days after third dose booster; Group B_0_1: At 3 (group B_0_1_1 only), 7 (sub-group B_0_1_2 only) and 30 days post-second dose.
Percentage of Subjects With hSBA ≥1:5 After Booster Dose/Second Vaccination of rMenB+OMV NZ
Bactericidal activity was measured against the N. meningitidis group B indicator strains H44/76 and M10713. On day 1, subjects in the Group B_0_1 were to be randomized into 2 different blood draw schedules according to a 1:1 ratio : 2 blood samples at different time points:
Group B_0_1_1: blood draws at 3 and 30 days after the second dose. Group B_0_1_2: blood draws at 7 and 30 days after the second dose. This outcome measure was assessed only for strains H44/76 and M10713.
Measured: Group 3B: 3, 7 and 30 days after third dose booster; Group B_0_1: At 3 (group B_0_1_1 only), 7 (sub-group B_0_1_2 only) and 30 days post-second dose."
Percentage of Subjects With hSBA ≥1:8 After Booster Dose/Second Vaccination of rMenB+OMV NZ
Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713. On day 1, subjects in the Group B_0_1 were to be randomized into 2 different blood draw schedules according to a 1:1 ratio : 2 blood samples at different time points:
Group B_0_1_1: blood draws at 3 and 30 days after the second dose. Group B_0_1_2: blood draws at 7 and 30 days after the second dose.
Measured: Group 3B: 3, 7 and 30 days after third dose booster; Group B_0_1: At 3 (group B_0_1_1 only), 7 (sub-group B_0_1_2 only) and 30 days post-second dose.
Percentage of Subjects With hSBA ≥1:16 After Booster Dose/Second Vaccination of rMenB+OMV NZ
Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713. On day 1, subjects in the Group B_0_1 were to be randomized into 2 different blood draw schedules according to a 1:1 ratio : 2 blood samples at different time points:
Group B_0_1_1: blood draws at 3 and 30 days after the second dose. Group B_0_1_2: blood draws at 7 and 30 days after the second dose
Measured: Group 3B: 3, 7 and 30 days after third dose booster; Group B_0_1: At 3 (group B_0_1_1 only), 7 (sub-group B_0_1_2 only) and 30 days post-second dose
hSBA Geometric Mean Titers Prior to Booster/Second Dose of Vaccination & Post Booster/Second Dose of Vaccination.
Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713. On day 1, subjects in the Group B_0_1 were to be randomized into 2 different blood draw schedules according to a 1:1 ratio : 2 blood samples at different time points:
Group B_0_1_1: blood draws at 3 and 30 days after the second dose. Group B_0_1_2: blood draws at 7 and 30 days after the second dose.
Measured: Group 3B: Day 1 (pre-booster dose) and 3, 7 and 30 days after third dose booster; Group B_0_1: Pre 2nd dose and at 3 (group B_0_1_1 only), 7 (group B_0_1_2 only) and 30 days post second dose.
Geometric Mean Ratios (GMRs) of GMTs After Booster/Second Vaccination Versus Before Booster/Second Vaccination.
Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713 by calculating the GMRs of GMTs post-vaccination with a booster dose (Group 3B) versus pre-booster dose or second dose (Group B_0_1) of vaccination versus pre second dose.
Measured: Group 3B: Day 1 and 30 days after third dose booster; Group B_0_1: 30 days post-first dose and at 30 days post-second dose
Percentages of Subjects With at Least Four-fold Increase in hSBA Titers Pre-booster/Second Dose Vaccination- Compared to 3, 7 and 30 Days Post- Booster/Second Vaccination
The percentage of subjects with 4-fold rise at 3, 7, 30 days post-vaccination with a booster dose (follow-on subjects) /second dose (naive subjects) of rMenB+OMV NZ with respect to day 1 (follow-on subjects) / pre-second dose of rMenB+OMV NZ (naïve subjects). Percentage of subjects with four-fold rise in hSBA titers relative to baseline were defined as: • for a pre-vaccination titer < 4, a post-vaccination titer of at least 16; • for a pre-vaccination titer ≥ 4 but <LLOQ, a post vaccination titer of at least fourfold the LLOQ; • for a pre-vaccination titer ≥LLOQ, a post vaccination titer of at least fourfold the pre-vaccination titer.
Measured: Group 3B: at 3, 7 and 30 days after third dose booster; Group B_0_1: at 3 (group B_0_1_1 only), 7 (group B_0_1_2 only) and 30 days post second dose
Percentage of Subjects With hSBA ≥1:4 After Second Vaccination of rMenB+OMV NZ
Bactericidal activity was measured against the N. meningitidis group B indicator strains 5/99 and NZ98/254. Only subjects receiving a second vaccination (group B_0_1) were assessed for this outcome measure.
Measured: At Day 61 (30 days post second dose of vaccination.)
Percentage of Subjects With hSBA ≥1:5 After Second Vaccination of rMenB+OMV NZ
Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76 and M10713. Only subjects receiving a second vaccination (group B_0_1) were assessed for this outcome measure.
Measured: At Day 61 (30 days post second dose of vaccination.)
Percentage of Subjects With hSBA ≥1:8 After Second Vaccination of rMenB+OMV NZ.
Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713.
Only subjects receiving a second vaccination (group B_0_1) were assessed for this outcome measure.
Measured: At Day 61 (30 days post second vaccination)
Percentage of Subjects With hSBA ≥1:16 After Second Vaccination of rMenB+OMV NZ.
Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713.
Only subjects receiving a second vaccination (group B_0_1) were assessed for this outcome measure.
Measured: At Day 61 (30 days post second vaccination)
hSBA Geometric Mean Titers (GMTs) After Second Vaccination of rMenB+OMV NZ.
Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713.
Only subjects receiving a second vaccination (group B_0_1) were assessed for this outcome measure.
Measured: At Day 1 & Day 61 (30 days post second dose of vaccination)
Geometric Mean Ratio (GMRs) of GMTs One Month Post Second Vaccination Versus Pre Vaccination at Day 1
Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713.
Only subjects receiving a second vaccination (group B_0_1) were assessed for this outcome measure.
Measured: At Day 1 & Day 61 (30 days post 2nd vaccination)
Percentages of Subjects With at Least Four-fold Increase in hSBA Titers at Pre-First Vaccination Compared to One Month Post-Second Vaccination
The percentage of subjects with 4-fold rise at one month post-vaccination with a second dose (naïve subjects) of rMenB+OMV NZ with respect to day 1, to each and any one, two, three or all 4 indicator strains.
Percentage of subjects with four-fold rise in hSBA titers relative to baseline were defined as:
- for a pre-vaccination titer < 4, a post-vaccination titer of at least 16;
- for a pre-vaccination titer ≥ 4 but <LLOQ, a post vaccination titer of at least fourfold the LLOQ;
- for a pre-vaccination titer ≥LLOQ, a post vaccination titer of at least fourfold the pre-vaccination titer.
Only subjects receiving the second dose of vaccination(group B_0_1) were considered for this outcome measure.
Measured: At Day 61 (30 days post second dose of vaccination)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Nov 201523 Sep 2016

First posted18 May 2015 (estimated)
Study start17 Nov 2015
Primary completion23 Sep 2016
Study completion23 Sep 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Infections, MeningococcalStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 531 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02446743
Sponsor's protocol ID: 205218
Other IDs: V72_75, 2017-000093-11, 2017
Status last verified: Apr 2018
First submitted: 6 May 2015
Last updated: 8 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

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.
PubMed 30691980

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3b, Open Label, Controlled, Multi-Center, Extension Study to Assess the Persistence of Bactericidal Activity at 4 to 7.5 Years After Two Dose Primary Series of GlaxoSmithKline Biologicals Meningococcal B Recombinant Vaccine and the Response to a Third Dose in Adolescents and Young Adult Subjects Who Previously Participated in Parent Studies V72_41 (NCT01423084) and V72P10 (NCT00661713), Compared to Naïve Healthy Controls
ClinicalTrials.gov ID: NCT02446743
Acronym / sponsor ID: 205218
Conditions: Infections, Meningococcal
Keywords: Nervous System Diseases, Meningitis, Central Nervous System Diseases
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 531 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 17 Nov 2015 (actual)
Primary completion: 23 Sep 2016 (actual)
Study completion: 23 Sep 2016 (actual)
First posted: 18 May 2015 (estimated)
Results: Posted 13 Dec 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group 3B	Experimental	Biological: rMenB+OMV NZ (Meningococcal (Group B) multi component recombinant adsorbed vaccine)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 B_0_1	Active comparator	Biological: rMenB+OMV NZ (Meningococcal (Group B) multi component recombinant adsorbed vaccine)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.

Who may qualify

Ages: 15 to 24 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (6 listed)

Individuals who participated to Study V72_41 or V72P10 and have completed vaccination with rMenB+OMV NZ according to a 2-dose schedule
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.

Key exclusion criteria (10 listed)

Received a third dose of a Meningococcal group B vaccine prior to enrolment in this study.
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Biological	Group 3B, Group B_0_1

Primary outcome

Percentage of Subjects With Human Serum Bactericidal Activity (hSBA)≥1:4
Time frame: Group 3B: Day 1 (prior to booster dose); Group B_0_1: Day 1 (prior to first dose).
Bactericidal activity was measured against the N. meningitidis group B indicator strains 5/99 and NZ98/254. This outcome measure was assessed only for strains 5/99 and NZ98/254.
Percentage of Subjects With hSBA≥1:5
Time frame: Group 3B: Day 1 (prior to booster dose); Group B_0_1: Day 1 (prior to first dose).
Bactericidal activity was measured against the N. meningitidis group B indicator strains H44/76 and M10713. This outcome measure was assessed only for strains H44/76 and M10713.
Percentage of Subjects With hSBA Titers≥1:5 in Parent Studies-V72P10 and V72_41
Time frame: At one month after last vaccination in parent studies- V72P10 (Month 7) and V72_41 (Month 2)
Bactericidal activity was measured against the N. meningitidis group B indicator strains H44/76 and M10713
Percentage of Subjects With hSBA≥1:8
Time frame: Group 3B: Day 1 (prior to booster dose); Group B_0_1: Day 1 (prior to first dose).
Bactericidal activity was measured against each of the N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713
Percentage of Subjects With hSBA≥1:16
Time frame: Group 3B: Day 1 (prior to booster dose); Group B_0_1: Day 1 (prior to first dose).
Bactericidal activity was measured against each of the N. meningitidis group B Indicator strains H44/76,5/99,NZ98/254 and M10713
hSBA Geometric Mean Titers (GMTs) After the Last Dose of rMenB+OMV NZ Vaccination in the Parent Study.
Time frame: Group 3B: 1 month after the last rMenB+OMV NZ vaccination in parent study and Day 1(prior to booster dose); Group B_0_1: Day 1(prior to first dose)
Bactericidal activity was measured against each of the N. meningitidis group B indicator strains H44/76,5/99, NZ98/254 a nd M10713.
Geometric Mean Ratios (GMRs) of GMTs After the Last Dose of rMenB+OMV NZ Vaccination in the Parent Study Versus Day 1.
Time frame: Group 3B: 1 month after the last vaccination in parent study and Day 1 (prior to booster dose)
The GMRs of GMTs at Day 1 versus one month after the last dose of rMenB+OMV NZ vaccination in the parent study were calculated. Bactericidal activity was measured against each of the N. meningitidis group B indicator strains H44/76, 5/99,NZ98/254 and M10713.
Number of Subjects With Solicited Local and Systemic AEs.
Time frame: 7 days (including the day of vaccination) after each vaccination
Solicited adverse events are signs and symptoms derived from organized data collection systems, such as Subject Diaries or interview. The percentage and frequencies of subjects reporting solicited local and systemic AEs were tabulated. Threshold for any Erythema, Swelling and Induration: >= 25 mm Note:Vaccination 2 was performed only on group B_0_1 subjects. Threshold for any Erythema, Swelling and Induration: >= 25 mm
Number of Subjects With Any Unsolicited Adverse Events (AEs).
Time frame: 30 days (including the day of vaccination) after each vaccination.
An unsolicited adverse event is an adverse event that was not solicited using a subject Diary and that was spontaneously communicated by a subject and/or parent(s)/legal guardian(s) who has signed the informed consent. Note : Vaccination 2 was performed only on group B_0_1 subjects.
Number of Subjects With Any SAEs, AEs Leading to Withdrawal and Medically Attended AEs.
Time frame: Group 3B: from Day 1 to Day 31 (study termination visit) and Group B_0_1: from Day 1 to Day 61 (study termination visit)
A serious adverse event is any untoward medical occurrence that at any dose results in death or is life threatening or requires prolonged hospitalization, leads to Persistent or significant disability/incapacity.

21 secondary outcomes

Percentage of Subjects With hSBA ≥1:4 After Booster Dose/First Vaccination of rMenB+OMV NZ.
Time frame: Group 3B: 30 days after booster dose, Group B_0_1 : 30 days after first vaccination.
Percentage of Subjects With hSBA ≥1:5 After Booster Dose/First Vaccination of rMenB+OMV NZ.
Time frame: Group 3B: 30 days after booster dose, Group B_0_1 : 30 days after first vaccination.
Percentage of Subjects With hSBA ≥1:8 After Booster Dose/First Vaccination of rMenB+OMV NZ
Time frame: Group 3B : 30 days after booster dose, Group B_0_1 : 30 days after first vaccination.
Percentage of Subjects With hSBA ≥1:16 After Booster Dose/First Vaccination of rMenB+OMV NZ
Time frame: Group 3B: 30 days after booster dose, Group B_0_1 : 30 days after first vaccination.
hSBA Geometric Mean Titers Prior to Booster/First Dose of Vaccination & Post Booster/First Dose of Vaccination.
Time frame: Group 3B subjects: Day 1(pre-booster dose) and 30 days post-booster dose. Group B_0_1: Day 1 (pre-first dose) and 30 days post-first dose.
Geometric Mean Ratio (GMRs) of GMTs After Booster Dose/First rMenB+OMV NZ Vaccination Versus Day 1.
Time frame: At Day 31 (30 days post booster dose/first dose of vaccination) versus Day 1 (prior to booster dose/first dose of vaccination).
Percentages of Subjects With at Least 4-fold Increase in hSBA Titers Pre Vaccination Compared to One Month Post-booster/First rMenB+OMV NZ Vaccination
Time frame: Group 3B: 1 month after booster dose; Group B_0_1: 1 month after first vaccination
Percentage of Subjects With hSBA ≥1:4 After Booster Dose/Second Vaccination of rMenB+OMV NZ
Time frame: Group 3B: 3, 7 and 30 days after third dose booster; Group B_0_1: At 3 (group B_0_1_1 only), 7 (sub-group B_0_1_2 only) and 30 days post-second dose.
Percentage of Subjects With hSBA ≥1:5 After Booster Dose/Second Vaccination of rMenB+OMV NZ
Time frame: Group 3B: 3, 7 and 30 days after third dose booster; Group B_0_1: At 3 (group B_0_1_1 only), 7 (sub-group B_0_1_2 only) and 30 days post-second dose."
Percentage of Subjects With hSBA ≥1:8 After Booster Dose/Second Vaccination of rMenB+OMV NZ
Time frame: Group 3B: 3, 7 and 30 days after third dose booster; Group B_0_1: At 3 (group B_0_1_1 only), 7 (sub-group B_0_1_2 only) and 30 days post-second dose.
Percentage of Subjects With hSBA ≥1:16 After Booster Dose/Second Vaccination of rMenB+OMV NZ
Time frame: Group 3B: 3, 7 and 30 days after third dose booster; Group B_0_1: At 3 (group B_0_1_1 only), 7 (sub-group B_0_1_2 only) and 30 days post-second dose
hSBA Geometric Mean Titers Prior to Booster/Second Dose of Vaccination & Post Booster/Second Dose of Vaccination.
Time frame: Group 3B: Day 1 (pre-booster dose) and 3, 7 and 30 days after third dose booster; Group B_0_1: Pre 2nd dose and at 3 (group B_0_1_1 only), 7 (group B_0_1_2 only) and 30 days post second dose.
Geometric Mean Ratios (GMRs) of GMTs After Booster/Second Vaccination Versus Before Booster/Second Vaccination.
Time frame: Group 3B: Day 1 and 30 days after third dose booster; Group B_0_1: 30 days post-first dose and at 30 days post-second dose
Percentages of Subjects With at Least Four-fold Increase in hSBA Titers Pre-booster/Second Dose Vaccination- Compared to 3, 7 and 30 Days Post- Booster/Second Vaccination
Time frame: Group 3B: at 3, 7 and 30 days after third dose booster; Group B_0_1: at 3 (group B_0_1_1 only), 7 (group B_0_1_2 only) and 30 days post second dose
Percentage of Subjects With hSBA ≥1:4 After Second Vaccination of rMenB+OMV NZ
Time frame: At Day 61 (30 days post second dose of vaccination.)
Percentage of Subjects With hSBA ≥1:5 After Second Vaccination of rMenB+OMV NZ
Time frame: At Day 61 (30 days post second dose of vaccination.)
Percentage of Subjects With hSBA ≥1:8 After Second Vaccination of rMenB+OMV NZ.
Time frame: At Day 61 (30 days post second vaccination)
Percentage of Subjects With hSBA ≥1:16 After Second Vaccination of rMenB+OMV NZ.
Time frame: At Day 61 (30 days post second vaccination)
hSBA Geometric Mean Titers (GMTs) After Second Vaccination of rMenB+OMV NZ.
Time frame: At Day 1 & Day 61 (30 days post second dose of vaccination)
Geometric Mean Ratio (GMRs) of GMTs One Month Post Second Vaccination Versus Pre Vaccination at Day 1
Time frame: At Day 1 & Day 61 (30 days post 2nd vaccination)
Percentages of Subjects With at Least Four-fold Increase in hSBA Titers at Pre-First Vaccination Compared to One Month Post-Second Vaccination
Time frame: At Day 61 (30 days post second dose of vaccination)

Results and safety

Results posted to the registry on 13 Dec 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 3B	276	271
Group B_0_1	255	250

Primary outcome: Percentage of Subjects With Human Serum Bactericidal Activity (hSBA)≥1:4

Time frame: Group 3B: Day 1 (prior to booster dose); Group B_0_1: Day 1 (prior to first dose).. Number (95% Confidence Interval). Unit: Percentage of subjects

Measure	Group 3B (V72_41) n = 144	Group 3B (V72P10) n = 129	Group 3B n = 273	Group B_0_1 (V72_41) n = 105	Group B_0_1 (V72P10) n = 148	Group B_0_1 n = 253
5/99	84 (77 to 90)	84 (76.4 to 90.2)	84 (79.2 to 88.5)	7 (2.9 to 13.9)	24 (16.9 to 31.7)	17 (12.2 to 22.1)
NZ98/254	9 (4.9 to 14.9)	29 (21.1 to 37.3)	18 (13.9 to 23.4)	0 (0 to 3.5)	14 (9 to 20.9)	8 (5.2 to 12.4)

Group 3B (V72_41) vs Group B_0_1 (V72_41): Vaccine Group Difference: 77 (95% CI 68.1 to 84.1), Miettinen and Nurminen score method
Group 3B (V72P10) vs Group B_0_1 (V72P10): Vaccine group difference: 60 (95% CI 49.9 to 69.2), Miettinen and Nurminen score method
Group 3B vs Group B_0_1: Vaccine group difference: 68 (95% CI 60.5 to 73.5), Miettinen and Nurminen score method

Population analysed: Analysis was performed on the Full analysis set (FAS) persistence. The FAS included all follow-on subjects (Group 3B) in the All Enrolled Set,\& all naïve subjects (group B\_0\_1) in the All Enrolled Set who provided evaluable immunogenicity result at day 1,for at least one indicator strain.

Primary outcome: Percentage of Subjects With hSBA≥1:5

Time frame: Group 3B: Day 1 (prior to booster dose); Group B_0_1: Day 1 (prior to first dose).. Number (95% Confidence Interval). Unit: Percentage of subjects

Measure	Group 3B (V72_41) n = 144	Group 3B (V72P10) n = 131	Group 3B n = 275	Group B_0_1 (V72_41) n = 105	Group B_0_1 (V72P10) n = 150	Group B_0_1 n = 255
H44/76	26 (19.4 to 34.4)	41 (32.7 to 50.2)	33 (27.9 to 39.4)	5 (1.6 to 10.8)	11 (6.7 to 17.5)	9 (5.5 to 12.8)
M10713	71 (63.2 to 78.6)	78 (69.8 to 84.6)	74 (68.9 to 79.5)	59 (49.0 to 68.5)	78 (70.5 to 84.3)	70 (64.2 to 75.7)

Group 3B vs Group B_0_1: vaccine group difference: 25 (95% CI 18.2 to 31.4), Miettinen and Nurminen score method
Group 3B (V72_41) vs Group B_0_1 (V72_41): Vaccine groups difference: 22 (95% CI 13.2 to 30.1), Miettinen and Nurminen score method
Group 3B (V72P10) vs Group B_0_1 (V72P10): Vaccine group difference: 30 (95% CI 20.0 to 39.6), Miettinen and Nurminen score method

Population analysed: Analysis was performed on the Full analysis set (FAS) persistence.The FAS included all follow-on subjects (Group 3B) in the All Enrolled Set, and all naïve subjects (group B\_0\_1) in the All Enrolled Set who provided evaluable immunogenicity result at day 1, for at least one indicator strain.

Primary outcome: Percentage of Subjects With hSBA Titers≥1:5 in Parent Studies-V72P10 and V72_41

Time frame: At one month after last vaccination in parent studies- V72P10 (Month 7) and V72_41 (Month 2). Number (95% Confidence Interval). Unit: Percentage of subjects

Measure	Group 3B (V72_41) n = 144	Group 3B (V72P10) n = 131
H44/76- Baseline in Parent study	1 (0.17 to 4.9)	23 (16 to 31.1)
H44/76- 1 month after last vacc in Parent study	99 (95.1 to 99.83)	100 (97.2 to 100)
M10713- Baseline in Parent study	34 (25.9 to 41.9)	73 (64 to 80)
M10713- 1 month after last vacc in Parent study	68 (59.4 to 75.5)	98 (94.6 to 99.81)

Population analysed: Analysis was performed on the Full analysis set (FAS) persistence. The FAS included all follow-on subjects (Group 3B) in the All Enrolled Set, and all naïve subjects (group B\_0\_1) in the All Enrolled Set who provided evaluable immunogenicity result at day 1, for at least one indicator strain.

Primary outcome: Percentage of Subjects With hSBA≥1:8

Time frame: Group 3B: Day 1 (prior to booster dose); Group B_0_1: Day 1 (prior to first dose).. Number (95% Confidence Interval). Unit: Percentage of subjects

Measure	Group 3B (V72_41) n = 144	Group 3B (V72P10) n = 131	Group 3B n = 275	Group B_0_1 (V72_41) n = 105	Group B_0_1 (V72P10) n = 150	Group B_0_1 n = 255
H44/76	22 (15.7 to 29.9)	35 (27.0 to 43.9)	28 (23.1 to 34.1)	1 (0.02 to 5.2)	9 (5.2 to 15.2)	6 (3.3 to 9.5)
5/99	78 (70.4 to 85.0)	83 (75.4 to 89.5)	81 (75.3 to 85.4)	4 (1.1 to 9.9)	19 (13.2 to 27.0)	13 (9.0 to 17.9)
NZ98/254	7 (3.4 to 12.4)	22 (15.6 to 30.7)	14 (10.4 to 19.0)	0 (0.0 to 3.5)	9 (5.3 to 15.4)	6 (3.1 to 9.1)
M10713	62 (53.0 to 69.5)	75 (66.5 to 82.0)	68 (62.0 to 73.4)	52 (42.4 to 62.2)	71 (62.7 to 77.8)	63 (56.9 to 69.1)

Group 3B vs Group B_0_1: Vaccine group difference: 22 (95% CI 16.5 to 28.6), Miettinen and Nurminen score method
Group 3B (V72_41) vs Group B_0_1 (V72_41): Vaccine group difference: 21 (95% CI 14.6 to 28.9), Miettinen and Nurminen score method
Group 3B (V72P10) vs Group B_0_1 (V72P10): Vaccine group difference: 26 (95% CI 16.4 to 35.3), Miettinen and Nurminen score method

Population analysed: Analysis was performed on the Full analysis set (FAS) persistence. The FAS included all follow-on subjects (Group 3B) in the All Enrolled Set, and all naïve subjects (group B\_0\_1) in the All Enrolled Set who provided evaluable immunogenicity result at day 1, for at least one indicator strain.

21 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited AEs were collected until 7 days after vaccinations. Unsolicited AEs were collected 30 days after each vaccination at day 31 (all subjects) and at day 61 (group B_0_1 subjects only).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 3B	0 of 275 (0%)	266 of 275 (96.7%)	0 of 275
Group B_0_1	1 of 255 (0.4%)	253 of 255 (99.2%)	0 of 255

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30691980Nolan 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

12 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Canada, Australia, Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Subjects With Human Serum Bactericidal Activity (hSBA)≥1:4 (time frame: Group 3B: Day 1 (prior to booster dose); Group B_0_1: Day 1 (prior to first dose).). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02446743, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2018.