Understanding the Persistence of Immunity After MenC Vaccines

This study has been completed.
Sponsor:
Information provided by:
University of Oxford
ClinicalTrials.gov Identifier:
NCT01126996
First received: May 18, 2010
Last updated: May 7, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Healthy
Procedure: Venepuncture

Study Type: Observational
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

Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Percentage of participants with rSBA titres >1:8 (correlate of protection) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 240
Study Start Date: June 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
MenC vaccinated healthy children
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).

  Eligibility

Ages Eligible for Study:   3 Years to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

Inclusion Criteria:

  • Participant whose parent is willing and able to give informed consent for participation in the study.
  • Participant who gives assent for participation in the study.
  • Male or Female, aged 11 to 13 years.
  • Known to be free from medical problems as determined by a medical history and clinical assessment
  • Participated in the University of Oxford clinical trial: U01-Td5I-303/ C01.183

Exclusion Criteria:

  • History of invasive meningococcal C disease
  • Any vaccination against MenC disease with the exception of a single dose in 2000 during the nationwide MenC immunisation campaign
  • Confirmed or suspected immunosuppressive or immunodeficient conditions, including human immunodeficiency virus (HIV) infection.
  • Major congenital defects or serious chronic illness
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01126996

Locations
United Kingdom
Oxford Vaccine Group, University of Oxford
Oxford, United Kingdom, OX3 7LJ
Sponsors and Collaborators
University of Oxford
Investigators
Principal Investigator: Matthew Snape University of Oxford
  More Information

Publications:
Responsible Party: Ms Heather House, University of Oxford, CTRG
ClinicalTrials.gov Identifier: NCT01126996     History of Changes
Other Study ID Numbers: OVG 2009/06
Study First Received: May 18, 2010
Last Updated: May 7, 2013
Health Authority: United Kingdom: Department of Health

Keywords provided by University of Oxford:
MenC conjugate vaccine
Healthy children previously vaccinated against MenC

ClinicalTrials.gov processed this record on April 15, 2014