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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MenC vaccinated healthy children | Children who received a single dose of a MenC conjugate vaccine at age 1-3 years 10 years earlier. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venepuncture | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with rSBA titres >1:8 (correlate of protection) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| MenC rSBA GMTs at all time points when sera is available after receiving a dose of MenC vaccine | 6 months | |
| Percentage of children at each time point with MenC SBA titres >1:8 | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Snape | University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oxford Vaccine Group, University of Oxford | Oxford | OX3 7LJ | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22038849 | Background | Khatami A, Peters A, Robinson H, Williams N, Thompson A, Findlow H, Pollard AJ, Snape MD. Maintenance of immune response throughout childhood following serogroup C meningococcal conjugate vaccination in early childhood. Clin Vaccine Immunol. 2011 Dec;18(12):2038-42. doi: 10.1128/CVI.05354-11. Epub 2011 Oct 28. |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |