There is evidence of waning immunity in individuals vaccinated against meningitis C as part of the UK infant immunisation schedule. The intention of this study is to contact participants of a previous NVEC (National Vaccine Evalutaion Consortium) clinical trial (a PreSchool Men C trial, in which participants were randomised to receive Meningitec, Menjugate or Neisvac-C). They will be invited to enrol and will be randomised to receive one of two quadrivalent meningococcal ACWY vaccines, to look at the boosting effect they may confer.
Between 550 and 650 subjects enrolled in a previous Meningococcal C vaccine study will be invited to join this new study looking at the boosting effects of two quadrivalent meningococcal ACWY vaccines. If they choose to participate, they will be randomised to receive one of the ACWY vaccines. Within each vaccine group, there will be further division into short (6 months) or longer (9 months) follow-up. Each participant will be given one dose of an allocated vaccine. Blood samples will be taken three times from each participant - the first sample will be pre-vaccination; the second sample will be taken one month after vaccination; and the third and final sample at either six or nine months after vaccination (depending on the group they are randomised to).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
91
Single dose Menveo (a MenACWY vaccine conjugated to CRM-197).
Single dose MenACWY-TT (MenACWY vaccine conjugated to Tetanus Toxoid, TT)
Multiple General Practice surgeries
Gloucester, Gloucestershire, United Kingdom
Multiple General Practice surgeries
Hertford, Hertfordshire, United Kingdom
Health Protection Agency, Immunisation Department, Colindale
London, United Kingdom
Response to meningococcal components of the vaccines by serum bactericidal antibody
Percentage of participants with serogroup-specific rabbit Serum Bactericidal Antibody (rSBA) titres ≥ 8 at one month post vaccination, for each of the serogroups A, C, W135 and Y. (This titre of rSBA is a documented correlate of protection for meningococcal conjugate vaccines)
Time frame: December 2013
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