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

Novartis

Status and phase: Completed; Phase 3

Conditions: Meningococcal Disease

Treatments: Biological: rMenB+OMV

Study type: Interventional

Funder types: Industry

Identifiers

NCT02141516

V72_62

2013-002454-78 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 239 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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239 participants in 3 patient groups

Group A

Experimental group

Description:

Complement deficiency

Treatment:

Biological: rMenB+OMV

Biological: rMenB+OMV

Biological: rMenB+OMV

Group B

Experimental group

Description:

asplenia/splenic dysfunction

Treatment:

Biological: rMenB+OMV

Biological: rMenB+OMV

Biological: rMenB+OMV

Group C

Active Comparator group

Description:

age-matched healthy controls

Treatment:

Biological: rMenB+OMV

Biological: rMenB+OMV

Biological: rMenB+OMV