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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02141516
Other study ID # V72_62
Secondary ID 2013-002454-78
Status Completed
Phase Phase 3
First received May 15, 2014
Last updated March 20, 2015
Start date May 2014
Est. completion date March 2015

Study information

Verified date March 2015
Source Novartis
Contact n/a
Is FDA regulated No
Health authority Spain: Agencia Española de Medicamentos y Productos SanitariosUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyRussia: Ministry of Health of Russian FederationItaly: AIFAPoland: URPL
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 239
Est. completion date March 2015
Est. primary completion date March 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 2 Years to 17 Years
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
rMenB+OMV
2 doses of vaccine 2 months apart
rMenB+OMV
2 doses of vaccine 2 months apart
rMenB+OMV
2 doses of vaccine 2 months apart

Locations

Country Name City State
Italy 12, Novartis Investigational Site Firenze
Italy 11, Novartis Investigational Site Genova
Italy 10, Novartis Investigational Site Milano
Italy 14, Novartis Investigational Site Padova
Italy 13, Novartis Investigational Site Roma
Poland 31, Novartis Investigational Site Krakow
Poland 33, Novartis Investigational Site Warszawa
Poland 30, Novartis Investigational Site Wroclaw
Russian Federation 41, Novartis Investigational Site Moscow
Russian Federation 42, Novartis Investigational Site Moscow
Russian Federation 43, Novartis Investigational Site Yekaterinburg
Spain 21, Novartis Investigational Site Barcelona
Spain 22, Novartis Investigational Site Madrid
Spain 23, Novartis Investigational Site Madrid
Spain 20, Novartis Investigational Site Santiago De Compostela
Spain 24, Novartis Investigational Site Valencia
United Kingdom 53, Novartis Investigational Site London
United Kingdom 52, Novartis Investigational Site Manchester
United Kingdom 50, Novartis Investigational Site Oxford
United Kingdom 51, Novartis Investigational Site Southampton

Sponsors (2)

Lead Sponsor Collaborator
Novartis Novartis Vaccines

Countries where clinical trial is conducted

Italy,  Poland,  Russian Federation,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary hSBA GMT, GMR, percentage of subjects with hSBA titers =5 and = 8 against serogroups B indicator strains and ELISA GMC, GMR for vaccine antigen 287-953 To evaluate the immunogenicity of two doses of rMenB+OMV NZ in subjects with increased risk of meningococcal disease because of complement deficiency or asplenia and in healthy age-matched subjects, at 1 month after the second vaccination. 30 days after 2nd vaccination No
Primary percentage of subject with four-fold increase in hSBA titers against serogroups B indicator strains and in ELISA concentration for vaccine antigen 287-953 30 days after 2nd vaccination No
Primary Frequencies and percentage of subjects with solicited AE unsolicited AE, medically attended AEs, AEs leading to withdrawn and SAEs To assess the safety and tolerability of two doses of rMenB+OMV NZ in subjects with increased risk of meningococcal disease because of complement deficiency or asplenia and in healthy age-matched subjects participants will be followed for the duration of study, within an expected average of 3 months Yes
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