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Understanding the Persistence of Immunity After MenC Vaccines

NCT01126996 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 240

Last updated 2013-05-09

No results posted yet for this study

Summary

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.

Conditions

  • Healthy

Interventions

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).

Sponsors & Collaborators

  • University of Oxford

    lead OTHER

Principal Investigators

  • Matthew Snape · University of Oxford

Eligibility

Min Age
3 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01126996 on ClinicalTrials.gov