Understanding the Persistence of Immunity After MenC Vaccines

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2010-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Understanding Immunity Persistence After Adolescent MenC Vaccination

NCT01459432

Antibody Persistance After Booster Dose of Men C Vaccine

COMPLETED

Can we Reduce the Number of Vaccine Injections for Children?

NCT01129518

Invasive Meningococcal Disease

COMPLETED PHASE4

MenPF-1 - A New Vaccine Against Meningococcal Disease

NCT01640652

Serogroup B Meningococcal Disease

COMPLETED PHASE1

Persistence of Antibodies After Meningococcal Vaccine PF-06866681 in Healthy Children

NCT01900899

Infections, Meningococcal

COMPLETED PHASE3

Investigating Meningococcal Vaccines in Adults

NCT02398396

Meningococcal Vaccines Meningococcal Infections Neisseria Meningitidis +1 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MenC vaccinated healthy children

Children who received a single dose of a MenC conjugate vaccine at age 1-3 years 10 years earlier.

Venepuncture

Intervention Type PROCEDURE

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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

3 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes