Clinical trial NCT02141516: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Meningococcal Disease
Keywords: Meningitis
vaccination
complement deficiency
asplenia
splenic dysfunction
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Novartis Vaccines
First posted: 2014-05-19
Enrollment: 239
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: 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.
timeFrame: Day 1 and Day 91 (one month after the second dose of the study vaccine)
measure: Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.
timeFrame: Day 1 and Day 91 (one month after the second dose of the study vaccine).
measure: Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.
timeFrame: Day 1 and Day 91 (one month after the second dose of the study vaccine).
measure: Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.
timeFrame: Day 1 and Day 91 (one month after the second dose of the study vaccine).
measure: 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.
timeFrame: Day 91 (one month after the second dose of the study vaccine).
measure: Geometric Mean Concentrations (GMCs) of Antibodies Against Vaccine Antigen 287-953 Following a 2-dose Vaccination Schedule.
timeFrame: Day 1 and Day 91 (one month after the second dose of the study vaccine).
measure: ELISA GMRs of Antibodies Against Vaccine Antigen 287-953 Following a 2-dose Vaccination Schedule.
timeFrame: Day 1 and Day 91 (one month after the second dose of the study vaccine).
measure: Percentage of Subjects With Four-fold Increases in ELISA Concentrations Against the Vaccine Antigen 287-953.
timeFrame: Day 91 (one month after the second dose of the study vaccine).
measure: Number Of Subjects With Unsolicited Adverse Events (AEs).
timeFrame: At Day1 through Day 7 after any vaccination and throughout the study period (Day 1 to Day 91)
Secondary outcomes:
measure: Number of Subjects Reporting Solicited Local and Systemic AEs.
timeFrame: From Day 1 until Day 7 after any vaccination.
Other outcomes:
Locations:
city: Firenze
country: Italy
facility: 12, Novartis Investigational Site
city: Genova
country: Italy
facility: 11, Novartis Investigational Site
city: Milano
country: Italy
facility: 10, Novartis Investigational Site
city: Padova
country: Italy
facility: 14, Novartis Investigational Site
city: Roma
country: Italy
facility: 13, Novartis Investigational Site
city: Krakow
country: Poland
facility: 31, Novartis Investigational Site
city: Warszawa
country: Poland
facility: 33, Novartis Investigational Site
city: Wroclaw
country: Poland
facility: 30, Novartis Investigational Site
city: Moscow
country: Russian Federation
facility: 42, Novartis Investigational Site
city: Moscow
country: Russian Federation
facility: 41, Novartis Investigational Site
city: Yekaterinburg
country: Russian Federation
facility: 43, Novartis Investigational Site
city: Barcelona
country: Spain
facility: 21, Novartis Investigational Site
city: Madrid
country: Spain
facility: 22, Novartis Investigational Site
city: Madrid
country: Spain
facility: 23, Novartis Investigational Site
city: Santiago De Compostela
country: Spain
facility: 20, Novartis Investigational Site
city: Valencia
country: Spain
facility: 24, Novartis Investigational Site
city: London
country: United Kingdom
facility: 53, Novartis Investigational Site
city: Manchester
country: United Kingdom
facility: 52, Novartis Investigational Site
city: Oxford
country: United Kingdom
facility: 50, Novartis Investigational Site
city: Southampton
country: United Kingdom
facility: 51, Novartis Investigational Site
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References:
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.