MenB vaccine for immunocompromised
Research type
Research Study
Full 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
IRAS ID
153358
Contact name
Matthew Snape
Contact email
Sponsor organisation
Novartis Vaccines & Diagnostics
Eudract number
2013-002454-78
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
This is an open label interventional trial in children who are at higher risk for meningococcal disease due to complement deficiency and problems with their spleen. This will be a multicentre study conducted across the EU.
Children who don’t have functioning complement system or a functioning spleen have a decreased ability to mount an immune response. They are therefore at increased risk of severe infections by bacteria, especially a group called ‘encapsulated bacteria’, which includes the meningococcal bacteria. They are therefore at higher risk than the general public of meningococcal disease.
The proposed study will aim to evaluate a vaccine – 4CMenB (also called rMenB+OMV NZ or Bexsero)– in this population. This vaccine protects from meningococcus B, which causes up to 90% of meningococcal disease in the UK. This vaccine has been licensed in Europe for children older than 2 months of age.
We will be exploring the safety of the vaccine and how the participant’s immune system responds to it. The participants will be between 2 and 17 years old. We will also have a control group of healthy age- matched children to compare to the study participants. The participant or participant’s parents will report any reactions to the vaccines, so we get an idea of the vaccine safety.
We will be checking the immune system with a blood test, two months after their second vaccine dose.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
14/SC/0232
Date of REC Opinion
22 May 2014
REC opinion
Further Information Favourable Opinion