Understanding the Persistence of Immunity After MenC Vaccines
Neisseria meningitidis occurs worldwide as endemic disease1 and is a major cause of invasive infections such as meningitis and septicaemia. Three protein-polysaccharide conjugate serogroup C meningococcal (MenC) vaccines were developed in the late 1990's and an accelerated programme of clinical trials in the UK led to licensure of these MenC vaccines in 1999 and these vaccines were introduced into the routine infant immunisation schedule at 2, 3 and 4 months. However, children who were aged 1-18 years in 2000 only received a single dose of a MenC conjugate vaccine during the mass immunisation campaign.
Previous studies have demonstrated rapid waning of MenC specific antibody concentrations and serum bactericidal antibody (SBA) titres following immunisation in young children. A cross-sectional review on rates of sero-protection against MenC disease in the UK has demonstrated that the majority of children who were immunised with a single dose of a MenC conjugate vaccine between the ages of 1-10 did not have protective titres of MenC SBA 7 years after the immunisation campaign. As this cohort of children reaches adolescence there is a risk of increased transmission of the organism and a resurgence of meningococcal disease in children who do not have protective levels of antibody. There is thus a need to conduct a study evaluating the changes in MenC SBA titres over time in children who received a single dose of a MenC vaccine in early childhood which is the main objective of this study.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||An Observational Study Into the Maintenance of Seroprotection Against Meningococcal Serogroup C Disease Throughout Childhood Following a Single Dose of a Conjugated Meningococcal Serogroup C Vaccine Administered to Toddlers|
- Percentage of participants with rSBA titres >1:8 (correlate of protection) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- MenC rSBA GMTs at all time points when sera is available after receiving a dose of MenC vaccine [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Percentage of children at each time point with MenC SBA titres >1:8 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||June 2010|
|Study Completion Date:||November 2010|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
MenC vaccinated healthy children
Children who received a single dose of a MenC conjugate vaccine at age 1-3 years 10 years earlier.