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

NCT ID: NCT02141516

Last Updated: 2017-02-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

239 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Meningococcal Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group A

Complement deficiency

Group Type EXPERIMENTAL

rMenB+OMV

Intervention Type BIOLOGICAL

2 doses of vaccine 2 months apart

Group B

asplenia/splenic dysfunction

Group Type EXPERIMENTAL

rMenB+OMV

Intervention Type BIOLOGICAL

2 doses of vaccine 2 months apart

Group C

age-matched healthy controls

Group Type ACTIVE_COMPARATOR

rMenB+OMV

Intervention Type BIOLOGICAL

2 doses of vaccine 2 months apart

Interventions

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rMenB+OMV

2 doses of vaccine 2 months apart

Intervention Type BIOLOGICAL

rMenB+OMV

2 doses of vaccine 2 months apart

Intervention Type BIOLOGICAL

rMenB+OMV

2 doses of vaccine 2 months apart

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

* 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.


* Previous known or suspected disease caused by N. meningitidis
* Known or suspected impairment/alteration of the immune system
Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis Vaccines

INDUSTRY

Sponsor Role collaborator

Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Vaccines

Role: STUDY_CHAIR

Novartis Vaccines

Locations

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12, Novartis Investigational Site

Florence, , Italy

Site Status

11, Novartis Investigational Site

Genova, , Italy

Site Status

10, Novartis Investigational Site

Milan, , Italy

Site Status

14, Novartis Investigational Site

Padua, , Italy

Site Status

13, Novartis Investigational Site

Roma, , Italy

Site Status

31, Novartis Investigational Site

Krakow, , Poland

Site Status

33, Novartis Investigational Site

Warsaw, , Poland

Site Status

30, Novartis Investigational Site

Wroclaw, , Poland

Site Status

42, Novartis Investigational Site

Moscow, , Russia

Site Status

41, Novartis Investigational Site

Moscow, , Russia

Site Status

43, Novartis Investigational Site

Yekaterinburg, , Russia

Site Status

21, Novartis Investigational Site

Barcelona, , Spain

Site Status

22, Novartis Investigational Site

Madrid, , Spain

Site Status

23, Novartis Investigational Site

Madrid, , Spain

Site Status

20, Novartis Investigational Site

Santiago de Compostela, , Spain

Site Status

24, Novartis Investigational Site

Valencia, , Spain

Site Status

53, Novartis Investigational Site

London, , United Kingdom

Site Status

52, Novartis Investigational Site

Manchester, , United Kingdom

Site Status

50, Novartis Investigational Site

Oxford, , United Kingdom

Site Status

51, Novartis Investigational Site

Southampton, , United Kingdom

Site Status

Countries

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Italy Poland Russia Spain United Kingdom

References

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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.

Reference Type DERIVED
PMID: 30068713 (View on PubMed)

Other Identifiers

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2013-002454-78

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

V72_62

Identifier Type: -

Identifier Source: org_study_id

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