Be on the TEAM: Teenagers Against Meningitis
| ISRCTN | ISRCTN75858406 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75858406 |
| EudraCT/CTIS number | 2017-004609-42 |
| Secondary identifying numbers | 37350 |
- Submission date
- 12/03/2018
- Registration date
- 14/03/2018
- Last edited
- 18/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Teenagers and young children are at increased risk of diseases such as meningitis and blood poisoning due to bacteria called meningococcus. Although these diseases can be serious, the meningococcus bacteria are carried in the back of the throat of 1 in 10 teenagers without causing any symptoms. Most meningococcal disease in teenagers is due to Meningitis B (also known as MenB). The aim of this study is to see whether immunising teenagers with vaccines against MenB can reduce the number of teenagers carrying these bacteria in their throat. This would be important because it could mean that teenage MenB immunisation would not only help protect teenagers against these potentially deadly diseases, but also that babies, children and older adults are less likely to be exposed to the bacteria. In short, immunising teenagers with a MenB vaccine might mean lower rates of meningococcal disease across all ages.
Who can participate?
Students aged 16-18 attending year 12 (or equivalent) at one of the participating 6th form colleges in England, Scotland and Wales
What does the study involve?
Participating schools are randomly allocated to deliver one of two types of MenB vaccine: 4CMenB (also known as Bexsero) and MenB-fHBP (also known as Trumenba). Participants either get two doses of 4CMenB or MenB-fHBP given 6 months apart at their first two study visits, or two doses of 4CMenB 1 to 6 months apart at their last two study visits. These vaccines are approved for use in the UK, but are not routinely given to teenagers in this country. Samples are collected from the participants’ throats to compare rates of MenB carriage before and after getting the MenB vaccine. Teenagers have three study visits over 12 to 18 months and all visits take place within schools.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
University of Oxford↨(UK)
When is the study starting and how long is it expected to run for?
October 2017 to March 2024
Who is funding the study?
1. Department of Health (UK)
2. Pfizer (UK)
Who is the main contact?
Emma Plested
Contact information
Scientific
Oxford Vaccine Group, University of Oxford
CCVTM
Churchill Hospital
Headington
Oxford
OX3 7LE
United Kingdom
Study information
| Study design | Non-randomised; Both; Design type: Prevention, Vaccine, Cross-sectional |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | School |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Evaluating the effect of immunisation with group B meningococcal vaccines on meningococcal carriage |
| Study objectives | Teenagers and young children are at increased risk of diseases such as meningitis and blood poisoning due to bacteria called meningococcus. Although these diseases can be serious, the meningococcus bacteria are ‘carried’ in the back of the throat of 1 in 10 teenagers without causing any symptoms. Most meningococcal disease in teenagers is due to Meningitis B (also known as MenB). The aim of this study is to find out whether immunising teenagers with vaccines against MenB can reduce the number of teenagers carrying these bacteria in their throat. This would be important because it could mean that teenage MenB immunisation would not only help protect teenagers against these potentially deadly diseases, but also that babies, children and older adults are less likely to be exposed to the bacteria. In short, immunising teenagers with a MenB vaccine might mean lower rates of meningococcal disease across all ages. |
| Ethics approval(s) | South Central – Berkshire B Research Ethics Committee, 02/03/2018, ref: 18/SC/0055 |
| Health condition(s) or problem(s) studied | Vaccination against meningitis |
| Intervention | Vaccines are randomly allocated by the project statistician on a site by site basis. Sites remain assigned to one vaccine group only for the duration of the study. Two types of MenB vaccine are used: 4CMenB (also known as Bexsero) and MenB-fHBP (also known as Trumenba). Participants in this study will either get two doses of 4CMenB or MenB-fHBP given 6 months apart at their first two study visits, or two doses of 4CMenB 1 to 6 months apart at their last two study visits. These vaccines are approved for use in the UK, but are not routinely given to teenagers in this country. The two doses of MenB vaccine will be given by IM injection into the deltoid by trained research nurses/doctors within the school setting. Oropharyngeal samples are collected from teenager’s throats to compare rates of MenB ‘carriage’ in teenagers before and after getting a MenB vaccine. Teenagers have three study visits, over 12 to 18 months and all visits would be held within schools. The follow up is 13 months for group 1 + 2 and up to 18 months for group 3. |
| Intervention type | Biological/Vaccine |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Bexsero, Trumenba |
| Primary outcome measure | Rates of carriage prevalence of any of meningococci genogroup B, C, W , X and Y before and after immunisation in both immunisation cohorts, compared with unimmunised controls; Timepoint(s): End of the study |
| Secondary outcome measures | Rates of carriage prevalence of particular Neisseria before and after immunisation in both immunisation cohorts, compared with controls, specifically: 1. Serogroup B meningococci 2. Hyper-invasive meningococcal strains 3. All meningococcal strains 4. Other Neisseria species 5. Meningococci of other non B serogroups and capsule null meningococci 6. Meningococci expressing antigens contained in 4CMenB and MenB-fHBP The difference in acquisition of carriage of all N. meningitidis over a 12-month period in both immunised cohorts compared to unvaccinated participants |
| Overall study start date | 01/10/2017 |
| Completion date | 31/03/2024 |
Eligibility
| Participant type(s) | All |
|---|---|
| Age group | Child |
| Lower age limit | 16 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 24000; UK Sample Size: 24000 |
| Total final enrolment | 24047 |
| Key inclusion criteria | 1. Male or female, aged 16-18 years attending year 12 (or equivalent) at one of the participating 6th form colleges in England, Scotland and Wales 2. Participant is willing and able to give informed consent for participation 3. In the Investigator’s opinion, is able and willing to comply with all trial requirements. 4. Willing to have bacterial isolates from throat swabs stored for future research in ethically approved studies 5. Willing to allow his or her General Practitioner to be contacted to confirm vaccination status if necessary |
| Key exclusion criteria | 1. Evidence of a course of either 4CMenB or MenB-fHBP in the past (documentation or self-report) 2. History of anaphylaxis to any component of 4CMenB or MenB-fHBP 3. Any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participants ability to participate 4. Participant is known to be pregnant |
| Date of first enrolment | 19/03/2018 |
| Date of final enrolment | 22/12/2019 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
Eastern Road
East Sussex
Brighton
BN2 5BE
United Kingdom
Education and Research Centre
Upper Maudlin Street
Bristol
BS2 8AE
United Kingdom
Tyndall Street
Cardiff
CF10 4BZ
United Kingdom
5 Cadogan Street
Glasgow
G2 6QE
United Kingdom
London
W2 1NY
United Kingdom
Maidstone Hospital
Hermitage Lane
Maidstone
ME16 9QQ
United Kingdom
Royal Manchester Children's Hospital
Oxford Road
Manchester
M13 9WL
United Kingdom
Derby Rd
Nottingham
NG7 2QW
United Kingdom
Churchill Hospital
Oxford
OX3 7LE
United Kingdom
Vicarage Lane
Fulwood
Preston
PR2 8DW
United Kingdom
Tremona Road
Southampton
SO16 6YD
United Kingdom
London
SW17 0RE
United Kingdom
Stockport NHS Foundation Trust
Stepping Hill Hospital
Stockport
SK2 7JE
United Kingdom
Hall Lane
Appley Bridge
WN6 9EP
United Kingdom
Sponsor information
Hospital/treatment centre
Clinical Trials and Research Governance (CTRG)
Joint Research Office, Block 60
Churchill Hospital
Oxford
OX3 7LJ
England
United Kingdom
"ROR" |
https://ror.org/052gg0110 |
|---|
Funders
Funder type
Government
No information available
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Pfizer Ltd, Pfizer Limited
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication of the results in a high impact peer reviewed journal as soon after the completion of the project as possible. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 22/10/2020 | 26/10/2020 | Yes | No |
| Protocol file | version 7.0 | 28/02/2022 | 09/05/2022 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol file | version 8.1 | 15/12/2023 | 08/01/2024 | No | No |
| Other publications | Observational study of the vacccination programme | 13/07/2022 | 18/06/2025 | Yes | No |
Additional files
Editorial Notes
18/06/2025: Publication reference added.
13/03/2024: The following changes have been made:
1. The intention to publish date was changed from 31/12/2024 to 31/03/2025.
2. The total final enrolment number was changed from 24048 to 24047.
08/01/2024: The following changes have been made:
1. The overall study end date was extended from 31/12/2023 to 31/03/2024 to allow for the completion of laboratory analyses.
2. Uploaded latest protocol v8.1 (not peer-reviewed) as an additional file.
18/12/2023: The following changes have been made:
1. The overall study end date has been changed from 30/11/2022 to 31/12/2023 and the plain English summary updated accordingly.
2. The intention to publish date has been changed from 31/12/2023 to 31/12/2024.
09/05/2022: From the Programme Manager: "We have had a fantastic response to the Be on the TEAM study and completed our recruitment target of 24000 participants at the end of 2019. Many thanks to all those that have helped us with this study. In March 2020 the closure of schools/colleges in response to the COVID-19 pandemic lead to the suspension of all study visits. Unfortunately, in light of the challenges posed by the pandemic, the study has stopped early and no further study visits will occur. This decision has been taken in consultation with the study funder, the study sponsor (the University of Oxford) and the study scientific advisory board, and reflects concerns about the feasibility and safety to staff and students of undertaking study visits in the coming months. Importantly, with the data already collected we anticipate that we will still be able to determine whether immunising with group B meningococcal vaccines reduces the carriage of this bacteria in the throats of teenagers."
The intention to publish date was changed from 30/11/2023 to 31/12/2023.
09/05/2022: Uploaded latest protocol v7.0 (not peer-reviewed) as an additional file.
15/12/2021: The following changes were made to the trial record:
1. The overall end date was changed from 31/05/2021 to 30/11/2022.
2. The intention to publish date was changed from 31/05/2022 to 30/11/2023.
3. The plain English summary was updated to reflect these changes.
26/10/2020: Publication reference added.
31/01/2020: The following changes have been made:
1. The recruitment end date has been changed from 20/12/2019 to 22/12/2019.
2. The total final enrolment number has been added.
06/12/2019: The recruitment end date has been changed from 30/11/2019 to 20/12/2019.
19/11/2019: The recruitment end date has been changed from 01/10/2019 to 30/11/2019.
27/03/2019: The condition has been changed from "Specialty: Infectious diseases and microbiology, Primary sub-specialty: Vaccines; UKCRC code/ Disease: Infection/ Other bacterial diseases" to "Vaccination against meningitis" following a request from the NIHR.
