search
Back to results

Safety and Immunogenicity of Novartis Meningococcal B Vaccine When Administered to Immunocompromised Children and Adolescents Compared to Healthy Subjects.

Primary Purpose

Meningococcal Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
rMenB+OMV
rMenB+OMV
rMenB+OMV
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Meningococcal Disease focused on measuring Meningitis, vaccination, complement deficiency, asplenia, splenic dysfunction

Eligibility Criteria

2 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Inclusion criterion applicable to All Groups

  • Subjects aged 2 to 17 years (inclusive) at enrollment
  • weighing at least 13 Kg at the time of enrollment

Inclusion criterion applicable to Group A - Subjects at risk of meningococcal disease because of primary or secondary complement deficiencies

Inclusion criterion applicable to Group B

- Subjects at risk of meningococcal disease because of functional or anatomic asplenia

Inclusion criterion applicable to Group C - healthy subjects

Exclusion Criteria:

Exclusion criteria applicable to All Groups (A, B and C)

  • History of any previous immunization with a meningococcal B vaccine
  • History of severe allergic reaction after previous vaccinations, or hypersensitivity to any component of the vaccine
  • Known HIV infection
  • History of any progressive or severe neurologic disorder or seizure disorder
  • Contraindication to intramuscular injection or blood drawn
  • Females who are pregnant, planning a pregnancy or nursing (breastfeeding)
  • Females of childbearing potential who have not used or do not plan to use acceptable birth control measures
  • History or any illness/condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects

Exclusion criterion applicable to Groups A and B

- Previous known or suspected disease caused by N. meningitidis in the last year.

Exclusion criteria applicable to Group C

  • Previous known or suspected disease caused by N. meningitidis
  • Known or suspected impairment/alteration of the immune system

Sites / Locations

  • 12, Novartis Investigational Site
  • 11, Novartis Investigational Site
  • 10, Novartis Investigational Site
  • 14, Novartis Investigational Site
  • 13, Novartis Investigational Site
  • 31, Novartis Investigational Site
  • 33, Novartis Investigational Site
  • 30, Novartis Investigational Site
  • 42, Novartis Investigational Site
  • 41, Novartis Investigational Site
  • 43, Novartis Investigational Site
  • 21, Novartis Investigational Site
  • 22, Novartis Investigational Site
  • 23, Novartis Investigational Site
  • 20, Novartis Investigational Site
  • 24, Novartis Investigational Site
  • 53, Novartis Investigational Site
  • 52, Novartis Investigational Site
  • 50, Novartis Investigational Site
  • 51, Novartis Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Group A

Group B

Group C

Arm Description

Complement deficiency

asplenia/splenic dysfunction

age-matched healthy controls

Outcomes

Primary Outcome Measures

Percentages of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Titers ≥ 5 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.
Immunogenicity was assessed in terms of percentage of subjects with hSBA titers ≥ 5 against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+Outer Membrane Vesicle (OMV) NZ, administered on Day 1 and Day 61.
Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.
Immunogenicity was assessed in terms of percentage of subjects with hSBA titers ≥ 8 against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.
Immunogenicity was assessed in terms of GMRs against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.
Immunogenicity was assessed in terms of GMTs against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
Percentages of Subjects With Four-fold Increases in hSBA Titers Against the Serogroup B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.
Antibody responses were assessed in terms of percentage of subjects achieving 4-fold increase in ELISA concentrations against vaccine antigen 287-953 on Day 91 over baseline (Day 1), following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
Geometric Mean Concentrations (GMCs) of Antibodies Against Vaccine Antigen 287-953 Following a 2-dose Vaccination Schedule.
Immune responses were measured as Enzyme-linked Immunosorbent Assay (ELISA) GMCs of antibodies against vaccine antigen 287-953 following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
ELISA GMRs of Antibodies Against Vaccine Antigen 287-953 Following a 2-dose Vaccination Schedule.
Immune responses were measured as ELISA GMRs of antibodies against vaccine antigen 287-953 following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
Percentage of Subjects With Four-fold Increases in ELISA Concentrations Against the Vaccine Antigen 287-953.
Antibody responses were assessed in terms of percentage of subjects achieving 4-fold increase in ELISA concentrations against vaccine antigen 287-953 on Day 91 over baseline (Day 1), following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
Number Of Subjects With Unsolicited Adverse Events (AEs).
Safety was assessed as the number of subjects who reported unsolicited AEs collected from Day1 through Day 7 after any vaccination; serious adverse events (SAEs), AEs leading to withdrawal and medically attended AEs were collected throughout the study period (Day1-Day 91).

Secondary Outcome Measures

Number of Subjects Reporting Solicited Local and Systemic AEs.
Reactogenicity was presented in terms of percentages of subjects reporting solicited local and systemic AEs and other indicators.

Full Information

First Posted
May 15, 2014
Last Updated
December 22, 2016
Sponsor
Novartis
Collaborators
Novartis Vaccines
search

1. Study Identification

Unique Protocol Identification Number
NCT02141516
Brief Title
Safety and Immunogenicity of Novartis Meningococcal B Vaccine When Administered to Immunocompromised Children and Adolescents Compared to Healthy Subjects.
Official Title
A Phase IIIb, Open Label, Controlled, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Doses of Novartis Meningococcal Group B Vaccine When Administered to Immunocompromised Patients From 2 to 17 Years of Age Who Are at Increased Risk of Meningococcal Disease Because of Complement Deficiency or Asplenia Compared to Matched Healthy Controls.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
Collaborators
Novartis Vaccines

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study aims at evaluating the safety and immunogenicity of rMenB+OMV NZ when administered to subjects from 2 to 17 years of age with increased risk of meningococcal disease because either of primary or secondary complement deficiencies or of asplenia or splenic dysfunction. A group of healthy age-matched subjects will be enrolled to serve as a descriptive control for immunogenicity and safety.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningococcal Disease
Keywords
Meningitis, vaccination, complement deficiency, asplenia, splenic dysfunction

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
239 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Complement deficiency
Arm Title
Group B
Arm Type
Experimental
Arm Description
asplenia/splenic dysfunction
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
age-matched healthy controls
Intervention Type
Biological
Intervention Name(s)
rMenB+OMV
Intervention Description
2 doses of vaccine 2 months apart
Intervention Type
Biological
Intervention Name(s)
rMenB+OMV
Intervention Description
2 doses of vaccine 2 months apart
Intervention Type
Biological
Intervention Name(s)
rMenB+OMV
Intervention Description
2 doses of vaccine 2 months apart
Primary Outcome Measure Information:
Title
Percentages of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Titers ≥ 5 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.
Description
Immunogenicity was assessed in terms of percentage of subjects with hSBA titers ≥ 5 against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+Outer Membrane Vesicle (OMV) NZ, administered on Day 1 and Day 61.
Time Frame
Day 1 and Day 91 (one month after the second dose of the study vaccine)
Title
Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.
Description
Immunogenicity was assessed in terms of percentage of subjects with hSBA titers ≥ 8 against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
Time Frame
Day 1 and Day 91 (one month after the second dose of the study vaccine).
Title
Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.
Description
Immunogenicity was assessed in terms of GMRs against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
Time Frame
Day 1 and Day 91 (one month after the second dose of the study vaccine).
Title
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.
Description
Immunogenicity was assessed in terms of GMTs against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
Time Frame
Day 1 and Day 91 (one month after the second dose of the study vaccine).
Title
Percentages of Subjects With Four-fold Increases in hSBA Titers Against the Serogroup B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.
Description
Antibody responses were assessed in terms of percentage of subjects achieving 4-fold increase in ELISA concentrations against vaccine antigen 287-953 on Day 91 over baseline (Day 1), following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
Time Frame
Day 91 (one month after the second dose of the study vaccine).
Title
Geometric Mean Concentrations (GMCs) of Antibodies Against Vaccine Antigen 287-953 Following a 2-dose Vaccination Schedule.
Description
Immune responses were measured as Enzyme-linked Immunosorbent Assay (ELISA) GMCs of antibodies against vaccine antigen 287-953 following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
Time Frame
Day 1 and Day 91 (one month after the second dose of the study vaccine).
Title
ELISA GMRs of Antibodies Against Vaccine Antigen 287-953 Following a 2-dose Vaccination Schedule.
Description
Immune responses were measured as ELISA GMRs of antibodies against vaccine antigen 287-953 following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
Time Frame
Day 1 and Day 91 (one month after the second dose of the study vaccine).
Title
Percentage of Subjects With Four-fold Increases in ELISA Concentrations Against the Vaccine Antigen 287-953.
Description
Antibody responses were assessed in terms of percentage of subjects achieving 4-fold increase in ELISA concentrations against vaccine antigen 287-953 on Day 91 over baseline (Day 1), following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
Time Frame
Day 91 (one month after the second dose of the study vaccine).
Title
Number Of Subjects With Unsolicited Adverse Events (AEs).
Description
Safety was assessed as the number of subjects who reported unsolicited AEs collected from Day1 through Day 7 after any vaccination; serious adverse events (SAEs), AEs leading to withdrawal and medically attended AEs were collected throughout the study period (Day1-Day 91).
Time Frame
At Day1 through Day 7 after any vaccination and throughout the study period (Day 1 to Day 91)
Secondary Outcome Measure Information:
Title
Number of Subjects Reporting Solicited Local and Systemic AEs.
Description
Reactogenicity was presented in terms of percentages of subjects reporting solicited local and systemic AEs and other indicators.
Time Frame
From Day 1 until Day 7 after any vaccination.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Inclusion criterion applicable to All Groups Subjects aged 2 to 17 years (inclusive) at enrollment weighing at least 13 Kg at the time of enrollment Inclusion criterion applicable to Group A - Subjects at risk of meningococcal disease because of primary or secondary complement deficiencies Inclusion criterion applicable to Group B - Subjects at risk of meningococcal disease because of functional or anatomic asplenia Inclusion criterion applicable to Group C - healthy subjects Exclusion Criteria: Exclusion criteria applicable to All Groups (A, B and C) History of any previous immunization with a meningococcal B vaccine History of severe allergic reaction after previous vaccinations, or hypersensitivity to any component of the vaccine Known HIV infection History of any progressive or severe neurologic disorder or seizure disorder Contraindication to intramuscular injection or blood drawn Females who are pregnant, planning a pregnancy or nursing (breastfeeding) Females of childbearing potential who have not used or do not plan to use acceptable birth control measures History or any illness/condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects Exclusion criterion applicable to Groups A and B - Previous known or suspected disease caused by N. meningitidis in the last year. Exclusion criteria applicable to Group C Previous known or suspected disease caused by N. meningitidis Known or suspected impairment/alteration of the immune system
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Vaccines
Organizational Affiliation
Novartis Vaccines
Official's Role
Study Chair
Facility Information:
Facility Name
12, Novartis Investigational Site
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Facility Name
11, Novartis Investigational Site
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
10, Novartis Investigational Site
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
14, Novartis Investigational Site
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
13, Novartis Investigational Site
City
Roma
ZIP/Postal Code
00165
Country
Italy
Facility Name
31, Novartis Investigational Site
City
Krakow
ZIP/Postal Code
31-302
Country
Poland
Facility Name
33, Novartis Investigational Site
City
Warszawa
ZIP/Postal Code
04-730
Country
Poland
Facility Name
30, Novartis Investigational Site
City
Wroclaw
ZIP/Postal Code
50-345
Country
Poland
Facility Name
42, Novartis Investigational Site
City
Moscow
ZIP/Postal Code
117198
Country
Russian Federation
Facility Name
41, Novartis Investigational Site
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
43, Novartis Investigational Site
City
Yekaterinburg
ZIP/Postal Code
620149
Country
Russian Federation
Facility Name
21, Novartis Investigational Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
22, Novartis Investigational Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
23, Novartis Investigational Site
City
Madrid
ZIP/Postal Code
46026
Country
Spain
Facility Name
20, Novartis Investigational Site
City
Santiago De Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
24, Novartis Investigational Site
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
53, Novartis Investigational Site
City
London
ZIP/Postal Code
WC1N 3JH
Country
United Kingdom
Facility Name
52, Novartis Investigational Site
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
50, Novartis Investigational Site
City
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Facility Name
51, Novartis Investigational Site
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
30068713
Citation
Martinon-Torres F, Bernatowska E, Shcherbina A, Esposito S, Szenborn L, Marti MC, Hughes S, Faust SN, Gonzalez-Granado LI, Yu LM, D'Agostino D, Calabresi M, Toneatto D, Snape MD. Meningococcal B Vaccine Immunogenicity in Children With Defects in Complement and Splenic Function. Pediatrics. 2018 Sep;142(3):e20174250. doi: 10.1542/peds.2017-4250. Epub 2018 Aug 1. Erratum In: Pediatrics. 2019 Mar;143(3):
Results Reference
derived

Learn more about this trial

Safety and Immunogenicity of Novartis Meningococcal B Vaccine When Administered to Immunocompromised Children and Adolescents Compared to Healthy Subjects.

We'll reach out to this number within 24 hrs