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

NCT02446743 | Completed Phase 3 Results DMC FDA Drug

• 3 other identifiers: 205218V72_752017-000093-11
• Study Type: interventional
• Target: 531
• Locations: 3 countries
• Sites: 12

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

Conditions

Infections, Meningococcal

Keywords

Nervous System Diseases; Meningitis; Central Nervous System Diseases

Outcome Measures

Primary Outcomes (10)

• 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.

  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.

  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

  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

  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

  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.

  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.

  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

  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.

  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.

  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.

  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.

  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

  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

  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.

  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.

Study Arms (2)

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.

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.

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

Interventions

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.

Group 3B; Group B_0_1

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• 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 .

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (12)

GSK Investigational Site

Sherwood, Queensland, 4075, Australia

Location

GSK Investigational Site

North Adelaide, South Australia, 5006, Australia

Location

GSK Investigational Site

Carlton, Victoria, 3010, Australia

Location

GSK Investigational Site

Subiaco, Western Australia, 6008, Australia

Location

GSK Investigational Site

Truro, Nova Scotia, B2N1L2, Canada

Location

GSK Investigational Site

Greater Sudbury, Ontario, P3E1H5, Canada

Location

GSK Investigational Site

Newmarket, Ontario, L3Y5G8, Canada

Location

GSK Investigational Site

Toronto, Ontario, M5G1N8, Canada

Location

GSK Investigational Site

Toronto, Ontario, M9V 4B4, Canada

Location

GSK Investigational Site

Woodstock, Ontario, N4S5P5, Canada

Location

GSK Investigational Site

Santiago, 7500092, Chile

Location

GSK Investigational Site

Santiago, 8380453, Chile

Location

Related Publications (1)

• 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.

  PMID: 30691980 DERIVED

MeSH Terms

Conditions

Meningococcal Infections; Nervous System Diseases; Meningitis; Central Nervous System Diseases

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Neuroinflammatory Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

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 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2015
• First Posted: May 18, 2015
• Study Start: November 17, 2015
• Primary Completion: September 23, 2016
• Study Completion: September 23, 2016
• Last Updated: November 8, 2018
• Results First Posted: December 13, 2017

Record last verified: 2018-04

Locations

AU (4); CA (6); CL (2)