NCT02141516

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

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 239 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Accepted

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.

Conditions

• Meningococcal Disease

Interventions

Type	Name	Description
BIOLOGICAL	rMenB+OMV	2 doses of vaccine 2 months apart
BIOLOGICAL	rMenB+OMV	2 doses of vaccine 2 months apart
BIOLOGICAL	rMenB+OMV	2 doses of vaccine 2 months apart

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2014-05-19
• Last updated: 2017-02-15
• Results posted: 2017-02-15

Locations

20 sites across 5 countries: Italy, Poland, Russia, Spain, United Kingdom