Baby Vaccine Study (Sched3)
Research type
Research Study
Full title
Assessment of post booster antibody responses in UK infants given a reduced priming schedule of meningococcal serogroup B and 13 valent pneumococcal conjugate vaccines
IRAS ID
165657
Contact name
Matthew Snape
Contact email
Sponsor organisation
Oxford University Hospitals NHS Foundation Trust
Eudract number
2015-000817-32
Duration of Study in the UK
1 years, 10 months, 30 days
Research summary
The Department of Health strives to provide protection as early as possible in life against serious infectious diseases through the delivery of a routine vaccination programme. As new vaccines become available and the epidemiology of diseases changes, revisions to the programme are made to ensure the best protection is afforded.
This study evaluates adding meningitis B vaccine to the current schedule, so revising it in terms of the number and timing of doses of meningitis C and pneumococcal vaccines to accommodate this. 200 infants due their primary immunisations will be recruited through GP surgeries in Hertfordshire and Gloucestershire, and through Child Health systems in Thames Valley. They will be randomised to one of two parallel groups to receive vaccinations at 2, 3, 4 and 12 months of age. All participants will have blood samples at 5 and 13 months of age for assessment of antibody levels against the various vaccines given, a well established method representing a proxy for protection against infectious disease. Where the antibody level does not meet that of an established level to indicate protection, an extra dose of vaccine(s) will be offered - this will apply to meningitis B and C, pneumococcal and Hib vaccines. We will also collect two nose swabs at 12 months and 18 months of age to allow us to see if the reduced number of doses of pneumococcal vaccine affects carriage of these bacteria in the nose. There will therefore be three visits outside those which would be attended for routine care i.e. for the samples, which may be conducted in the home if acceptable to research nurses and families.
Parents will be asked to complete a health diary following each vaccination visit to document how their baby has been, these data will again be compared between the two groups.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
15/SC/0355
Date of REC Opinion
22 Jun 2015
REC opinion
Favourable Opinion