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

December 22, 2016 updated by: Novartis

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

239

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Firenze, Italy, 50139
        • 12, Novartis Investigational Site
      • Genova, Italy, 16132
        • 11, Novartis Investigational Site
      • Milano, Italy, 20122
        • 10, Novartis Investigational Site
      • Padova, Italy, 35128
        • 14, Novartis Investigational Site
      • Roma, Italy, 00165
        • 13, Novartis Investigational Site
  • Poland
      • Krakow, Poland, 31-302
        • 31, Novartis Investigational Site
      • Warszawa, Poland, 04-730
        • 33, Novartis Investigational Site
      • Wroclaw, Poland, 50-345
        • 30, Novartis Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 117198
        • 42, Novartis Investigational Site
      • Moscow, Russian Federation, 117997
        • 41, Novartis Investigational Site
      • Yekaterinburg, Russian Federation, 620149
        • 43, Novartis Investigational Site
  • Spain
      • Barcelona, Spain, 08035
        • 21, Novartis Investigational Site
      • Madrid, Spain, 28046
        • 22, Novartis Investigational Site
      • Madrid, Spain, 46026
        • 23, Novartis Investigational Site
      • Santiago De Compostela, Spain, 15706
        • 20, Novartis Investigational Site
      • Valencia, Spain, 46026
        • 24, Novartis Investigational Site
  • United Kingdom
      • London, United Kingdom, WC1N 3JH
        • 53, Novartis Investigational Site
      • Manchester, United Kingdom, M13 9WL
        • 52, Novartis Investigational Site
      • Oxford, United Kingdom, OX3 7LE
        • 50, Novartis Investigational Site
      • Southampton, United Kingdom, SO16 6YD
        • 51, Novartis Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Complement deficiency
Biological: rMenB+OMV
2 doses of vaccine 2 months apart
Experimental: Group B
asplenia/splenic dysfunction
Biological: rMenB+OMV
2 doses of vaccine 2 months apart
Active Comparator: Group C
age-matched healthy controls
Biological: rMenB+OMV
2 doses of vaccine 2 months apart

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Day 1 and Day 91 (one month after the second dose of the study vaccine)
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.
Day 1 and Day 91 (one month after the second dose of the study vaccine)
Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.
Time Frame: Day 1 and Day 91 (one month after the second dose of the study vaccine).
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.
Day 1 and Day 91 (one month after the second dose of the study vaccine).
Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.
Time Frame: Day 1 and Day 91 (one month after the second dose of the study vaccine).
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.
Day 1 and Day 91 (one month after the second dose of the study vaccine).
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.
Time Frame: Day 1 and Day 91 (one month after the second dose of the study vaccine).
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.
Day 1 and Day 91 (one month after the second dose of the study vaccine).
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.
Time Frame: Day 91 (one month after the second dose of the study vaccine).
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.
Day 91 (one month after the second dose of the study vaccine).
Geometric Mean Concentrations (GMCs) of Antibodies Against Vaccine Antigen 287-953 Following a 2-dose Vaccination Schedule.
Time Frame: Day 1 and Day 91 (one month after the second dose of the study vaccine).
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.
Day 1 and Day 91 (one month after the second dose of the study vaccine).
ELISA GMRs of Antibodies Against Vaccine Antigen 287-953 Following a 2-dose Vaccination Schedule.
Time Frame: Day 1 and Day 91 (one month after the second dose of the study vaccine).
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.
Day 1 and Day 91 (one month after the second dose of the study vaccine).
Percentage of Subjects With Four-fold Increases in ELISA Concentrations Against the Vaccine Antigen 287-953.
Time Frame: Day 91 (one month after the second dose of the study vaccine).
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.
Day 91 (one month after the second dose of the study vaccine).
Number Of Subjects With Unsolicited Adverse Events (AEs).
Time Frame: At Day1 through Day 7 after any vaccination and throughout the study period (Day 1 to Day 91)
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).
At Day1 through Day 7 after any vaccination and throughout the study period (Day 1 to Day 91)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects Reporting Solicited Local and Systemic AEs.
Time Frame: From Day 1 until Day 7 after any vaccination.
Reactogenicity was presented in terms of percentages of subjects reporting solicited local and systemic AEs and other indicators.
From Day 1 until Day 7 after any vaccination.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Collaborators

Novartis Vaccines

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

May 15, 2014

First Submitted That Met QC Criteria

May 15, 2014

First Posted (Estimate)

May 19, 2014

Study Record Updates

Last Update Posted (Actual)

February 15, 2017

Last Update Submitted That Met QC Criteria

December 22, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V72_62
  • 2013-002454-78 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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