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

Meningococcal Disease Clinical Trial

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

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

• Meningococcal Disease
• Meningococcal Infections

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