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OpenTrials
Completed

NCT Number: NCT02141516

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

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.

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Key information

Conditions

Meningococcal Disease Bacterial Infections Bacterial Infections and Mycoses Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Gram-Negative Bacterial Infections Hereditary Complement Deficiency Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Meningitis Meningococcal Infections Neisseriaceae Infections Nervous System Diseases Neuroinflammatory Diseases Primary Immunodeficiency Diseases

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

12, Novartis Investigational Site, Florence, Italy

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rMenB+OMV

Biological

2 doses of vaccine 2 months apart

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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).

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Collaborators

  • Novartis Vaccines

Registry information

Official study 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.

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 19, 2014
Registry last updated
Feb 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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