An observational study in Healthy, sponsored by University of Oxford. Completed at 1 site in United Kingdom. Open to participants aged 3 Years to 9 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-05-09.
Sponsored by University of Oxford · Observational
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.
University of Oxford is the lead sponsor of 794 studies on the registry; 117 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Healthy children who participated in the U01-Td5I-303/ C01.183 study from 2001 to 2007 who will be aged 11 to 13 years in 2010, all of whom would have received a single dose of a MenC conjugate vaccine in 2000 as part of the nationwide immunisation campaign.
Exclusion Criteria:
Children who received a single dose of a MenC conjugate vaccine at age 1-3 years 10 years earlier.
Procedure: Venepuncture
1. Venepuncture and blood sample collection in 2010 in a sample of children who received a single dose of a MenC conjugate vaccine at age 1-3 years 10 years earlier. 2. A booster dose of a MenC conjugate vaccine (optional).
Percentage of participants with rSBA titres >1:8 (correlate of protection)
Time frame: 6 months
MenC rSBA GMTs at all time points when sera is available after receiving a dose of MenC vaccine
Time frame: 6 months
Percentage of children at each time point with MenC SBA titres >1:8
Time frame: 6 months
This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.
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