Condition category
Not Applicable
Date applied
04/02/2015
Date assigned
14/04/2015
Last edited
14/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The meningococcus is a bug that commonly lives at the back of the throat without causing any symptoms in people carrying it. Meningitis and blood poisoning are very serious diseases that can be caused by meningococcus (and some other bugs). Although only very few people get these diseases, teenagers and young children are at increased risk. A national meningococcal carriage study in seven UK sites is collecting one throat swab each from 18,000 healthy 15-19 year old school/college students. Of these, around 2,500 will be recruited in Bristol. The national study will tell us how many teenagers were carrying the bug on the day they had their swab taken, but it cannot tell us whether or how this changes over time. This new study is a follow-on to the national study. The aim of this additional study is to look at the natural changes in meningococcus carriage in greater detail.

Who can participate?
Healthy male and female students aged 15 to 19 years attending participating schools/colleges in Bristol who are enrolled in the meningococcal carriage study, and who agreed to be re-approached for this study.

What does the study involve?
We will take five further (monthly) throat swabs from 1,000 of the Bristol participants of the national study. The participants will also be asked to complete a brief questionnaire about factors that may affect meningococcus carriage (smoking, antibiotic use etc) at the time of each swab. We want to determine whether some people carry a larger number of bugs than others (high versus low carriers) and whether the amount of bug carried changes over time. We also want to find out how many people naturally stop carrying the bug, and how many who didn’t previously have it start carrying it (acquisition).

What are the possible benefits and risks of participating?
Understanding exactly how meningococcus carriage varies naturally will provide important information to help us use existing vaccines more effectively and develop better ones in the future.

Where is the study run from?
University of Bristol (UK).

When is the study starting and how long is it expected to run for?
From November 2014 to June 2016.

Who is funding the study?
National Institute of Health Research (NIHR) Health Protection Research Unit (HPRU) Evaluation of Interventions (UK).

Who is the main contact?
Dr Jennifer Oliver
jennifer.oliver@bristol.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jennifer Oliver

ORCID ID

Contact details

Education Centre
Upper Maudlin Street
Bristol
BS2 8AE
United Kingdom

Type

Scientific

Additional contact

Prof Adam Finn

ORCID ID

http://orcid.org/0000-0003-1756-5668

Contact details

Education Centre
Upper Maudlin Street
Bristol
BS2 8AE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

17811

Study information

Scientific title

Follow on study of meningococcal carriage in 15-19 year old school students: description of the natural history of colonisation and development of laboratory and epidemiological tools for detailed studies of the potential impact of novel vaccines upon transmission

Acronym

Study hypothesis

Aim: To provide a detailed picture of the natural history of meningococcal carriage in adolescents in whom carriage and transmission is relatively common, and who are a potential target group both for vaccine studies to evaluate impact on carriage and transmission, and ultimately for intervention with universal immunisation programmes.

Objectives: Among 15-19 year old students in Bristol, UK:
1. Describe the distribution of carriage density
2. Provide detailed information on the duration of carriage
3. Provide detailed information on rates of acquisition of carriage
4. Clarify heterogeneity in patterns of carriage and specifically to what extent high density and long duration carriage characterises one or more specific subgroups of individuals

Ethics approval

NRES Committee London - Bromley, 14/07/2014, ref: 14/LO/1332

Study design

Non-randomised; Observational; Design type: Cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Children; Subtopic: All Diagnoses; Disease: All Diseases

Intervention

Oropharyngeal swab, 5 swabs, one at each visit; questionnaire, 5 short questionnaires on risk factors of meningococcal carriage, one at each visit; Study Entry: Registration only

Intervention type

Other

Phase

Drug names

Primary outcome measures

Distribution of carriage density; Timepoint(s): At entry and over the course of the study

Secondary outcome measures

1. Acquisition of carriage; Timepoint(s): rates over the course of the study
2. Duration of carriage; Timepoint(s): Over the course of the study
3. Patterns of carriage; Timepoint(s): heterogeneity over study period between subgroups, especially high density and long duration carriage

Overall trial start date

05/11/2014

Overall trial end date

30/06/2016

Reason abandoned

Eligibility

Participant inclusion criteria

The study will recruit healthy male and female students aged 15 to 19 years attending participating schools/colleges in Bristol who are enrolled in the Wellcome Trust funded cross-sectional meningococcal carriage study, and whose consent for that study included agreement to potentially be re-approached concerning this study. All subjects must provide signed informed consent to participate in this longitudinal study.
Target Gender: Male & Female; Upper Age Limit 19 years ; Lower Age Limit 15 years

Participant type

Healthy volunteer

Age group

Child

Gender

Both

Target number of participants

Planned Sample Size: 1000; UK Sample Size: 1000

Participant exclusion criteria

Any medical condition or circumstances which, in the opinion of the investigator, will jeopardise the likelihood of safe or effective participation in the study

Recruitment start date

05/11/2014

Recruitment end date

31/03/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Bristol Children's Vaccine Centre
Level 6, Education & Research Centre Upper Maudlin Street
Bristol
BS2 8AE
United Kingdom

Sponsor information

Organisation

University of Bristol

Sponsor details

Senate House
Tyndall Avenue
Bristol
BS8 1TH
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NIHR

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes