Understanding the Persistence of Immunity After MenC Vaccines

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01126996
Recruitment Status : Completed
First Posted : May 20, 2010
Last Update Posted : May 9, 2013
Information provided by:
University of Oxford

Brief 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.

Condition or disease Intervention/treatment
Healthy Procedure: Venepuncture

Study Type : Observational
Estimated Enrollment : 240 participants
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
Study Start Date : June 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Group/Cohort Intervention/treatment
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).

Primary Outcome Measures :
  1. Percentage of participants with rSBA titres >1:8 (correlate of protection) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. MenC rSBA GMTs at all time points when sera is available after receiving a dose of MenC vaccine [ Time Frame: 6 months ]
  2. Percentage of children at each time point with MenC SBA titres >1:8 [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01126996

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

Responsible Party: Ms Heather House, University of Oxford, CTRG Identifier: NCT01126996     History of Changes
Other Study ID Numbers: OVG 2009/06
First Posted: May 20, 2010    Key Record Dates
Last Update Posted: May 9, 2013
Last Verified: May 2013

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

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs