Vaccination/Immunisation StatusNCT04485624
Vaccination Coverage Amongst Children/Young People Attending the PED
An observational study of Vaccination/Immunisation Status, run by Lancaster University at 1 site in United Kingdom.
Trial summary
In the United Kingdom (UK), most childhood vaccinations are given in the community, although uptake has decreased in recent years. A Paediatric Emergency Department (PED) attendance offers an opportunity to check the vaccination status of children and young people (CYP) and all parents/carers should be asked about… Read more about this study
- Who is it for?
- Ages 0 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaccination/Immunisation Status
- How many people
- 2,693 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Jan 2021to 30 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children and young people accessing PED
Who may be able to join
- attending the study site PED; under the age of 16 at the time of attendance; able to give consent or accompanied by someone able to give consent
Who cannot join
- life threatening illness or injury
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Paediatric Emergency Department, North Manchester General Hospital
Manchester, Greater Manchester, M8 5RB
About this study
Official title: Do Children and Young People Attending the Paediatric Emergency Department Have Lower Levels of Vaccination Coverage Than Their Peers in the Local General Population?
In the United Kingdom (UK), most childhood vaccinations are given in the community, although uptake has decreased in recent years. A Paediatric Emergency Department (PED) attendance offers an opportunity to check the vaccination status of children and young people (CYP) and all parents/carers should be asked about this routinely. Those not up-to-date with vaccinations could then be signposted to existing services or perhaps offered a vaccine in the PED.
CYP attending the PED may also have lower vaccination coverage than their peers, so may benefit even more from interventions to increase uptake. However, recall by parents/carers is not always sufficiently accurate to identify those who have not yet received all their age-appropriate vaccinations. The most complete record of an individual's vaccination history is held within their primary care records. However, these records are often in a separate computer system that is inaccessible from the hospital's main computer system, although some information (including vaccination) may be accessed from within the hospital via a third system.
Read more
This study aims to see if CYP attending the PED are under-vaccinated compared to their peers and assess the accuracy of parent/carer recall. The results of this study will then be used to inform recommendations for developing better ways to access accurate vaccination data during a PED consultation. If such a system existed, under-vaccinated children could be identified routinely during an attendance, and an intervention offered if appropriate. This would be particularly useful if there was an outbreak of a vaccine-preventable disease such measles.
All CYP (< 16 years old) attending a PED in a district general hospital in Manchester will be invited to participate. CYP/their parent/carer will be asked to provide consent for their vaccination records to be accessed as well as being asked if the child/young person is up-to-date with all their vaccinations. Approximately 1000 participants will be enrolled.
- Conditions
- Vaccination/Immunisation Status
- Being tested
- No intervention
- Keywords
- Vaccination, Immunisation, Opportunistic, Child, Young person, Paediatric Emergency Department
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Observational study
| Study group | Role | What they receive |
|---|---|---|
| Attendees at Paediatric Emergency Department 1 (PED1) | These participants will be recruited from the children and young people (under the age of 16) attending the PED of a large district general hospital.
There was going to be a second group recruited but COVID meant that the site was not able to support non-COVID studies by the time the necessary approvals were in place. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of children/young people attending the PED who have received all of their age-appropriate vaccinations.
The % of children and young people attending the PED who have received all of their age-appropriate vaccinations will be compared to their peers in the local general population.
Measured: Through study completion (estimated one year)
Secondary outcomes (3)
Accuracy of parent/carer recall of the vaccination status of children/young people attending the PED.
The accuracy of parent/carer recall of the vaccination status of children/young people attending the PED will be made by comparing their responses to electronic community records.
Measured: Through study completion (estimated one year)
Percentage of children attending the PED who have received two doses of MMR by the age of 5 years.
The % of children attending the PED who have received two doses of the Measles, Mumps, and Rubella vaccine (MMR) by the age of 5 years will be compared to their peers in the local general population.
Measured: Through study completion (estimated one year)
Percentage of children attending the PED who have received at least one dose of MMR by the age of 2 years.
The % of children attending the PED who have received at least one dose of MMR by the age of 2 years will be compared to their peers in the local general population.
Measured: Through study completion (estimated one year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start24 Jan 2021
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vaccination/Immunisation StatusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 2,693 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lancaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Pennine Acute Hospitals NHS Trust
- Responsible party
- Principal investigator, Rachel Isba, Lancaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04485624
- Sponsor's protocol ID
- IRAS278815
- Status last verified
- Dec 2021
- First submitted
- 15 Jul 2020
- Last updated
- 30 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Isba R, Brennan L, Egboko F, Edge R, Davies N, Knight J. Unmet vaccination need among children under the age of five attending the paediatric emergency department: a cross-sectional study in a large UK district general hospital. BMJ Open. 2023 Jun 26;13(6):e072053. doi: 10.1136/bmjopen-2023-072053.
PubMed 37369415
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Children and Young People Attending the Paediatric Emergency Department Have Lower Levels of Vaccination Coverage Than Their Peers in the Local General Population?
- ClinicalTrials.gov ID
- NCT04485624
- Acronym / sponsor ID
- IRAS278815
- Conditions
- Vaccination/Immunisation Status
- Keywords
- Vaccination, Immunisation, Opportunistic, Child, Young person, Paediatric Emergency Department
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,693 participants (actual)
- Lead sponsor
- Lancaster UniversityUniversity, hospital or other
- Collaborators
- Pennine Acute Hospitals NHS Trust
- Study start
- 24 Jan 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 24 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the United Kingdom (UK), most childhood vaccinations are given in the community, although uptake has decreased in recent years. A Paediatric Emergency Department (PED) attendance offers an opportunity to check the vaccination status of children and young people (CYP) and all parents/carers should be asked about this routinely. Those not up-to-date with vaccinations could then be signposted to existing services or perhaps offered a vaccine in the PED.
CYP attending the PED may also have lower vaccination coverage than their peers, so may benefit even more from interventions to increase uptake. However, recall by parents/carers is not always sufficiently accurate to identify those who have not yet received all their age-appropriate vaccinations. The most complete record of an individual's vaccination history is held within their primary care records. However, these records are often in a separate computer system that is inaccessible from the hospital's main computer system, although some information (including vaccination) may be accessed from within the hospital via a third system.
This study aims to see if CYP attending the PED are under-vaccinated compared to their peers and assess the accuracy of parent/carer recall. The results of this study will then be used to inform recommendations for developing better ways to access accurate vaccination data during a PED consultation. If such a system existed, under-vaccinated children could be identified routinely during an attendance, and an intervention offered if appropriate. This would be particularly useful if there was an outbreak of a vaccine-preventable disease such measles.
All CYP (< 16 years old) attending a PED in a district general hospital in Manchester will be invited to participate. CYP/their parent/carer will be asked to provide consent for their vaccination records to be accessed as well as being asked if the child/young person is up-to-date with all their vaccinations. Approximately 1000 participants will be enrolled.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Attendees at Paediatric Emergency Department 1 (PED1) | – | Other: No interventionThese participants will be recruited from the children and young people (under the age of 16) attending the PED of a large district general hospital. There was going to be a second group recruited but COVID meant that the site was not able to support non-COVID studies by the time the necessary approvals were in place. |
Who may qualify
- Ages
- 0 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children and young people accessing PED
Key inclusion criteria (1 listed)
- attending the study site PED; under the age of 16 at the time of attendance; able to give consent or accompanied by someone able to give consent
Key exclusion criteria (1 listed)
- life threatening illness or injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionObservational study | Other | Attendees at Paediatric Emergency Department 1 (PED1) |
Primary outcome
Percentage of children/young people attending the PED who have received all of their age-appropriate vaccinations.
Time frame: Through study completion (estimated one year)
The % of children and young people attending the PED who have received all of their age-appropriate vaccinations will be compared to their peers in the local general population.
3 secondary outcomes
Accuracy of parent/carer recall of the vaccination status of children/young people attending the PED.
Time frame: Through study completion (estimated one year)
Percentage of children attending the PED who have received two doses of MMR by the age of 5 years.
Time frame: Through study completion (estimated one year)
Percentage of children attending the PED who have received at least one dose of MMR by the age of 2 years.
Time frame: Through study completion (estimated one year)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2021.
- Derived from this study: PubMed 37369415Isba R, Brennan L, Egboko F, Edge R, Davies N, Knight J. Unmet vaccination need among children under the age of five attending the paediatric emergency department: a cross-sectional study in a large UK district general hospital. BMJ Open. 2023 Jun 26;13(6):e072053. doi: 10.1136/bmjopen-2023-072053.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaccination/Immunisation Status, run by Lancaster University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of children/young people attending the PED who have received all of their age-appropriate vaccinations. (time frame: Through study completion (estimated one year)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04485624, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2021.