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Completed

NCT Number: NCT01126996

Understanding the Persistence of Immunity After MenC Vaccines

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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Key information

Conditions

Age range

3 year–9 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Oxford Vaccine Group, University of Oxford

Oxford, OX3 7LJ, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Venepuncture

Procedure
  • 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.
  • A booster dose of a MenC conjugate vaccine (optional).

Primary outcomes

  1. Percentage of participants with rSBA titres >1:8 (correlate of protection)

    Time frame: 6 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 20, 2010
Registry last updated
May 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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