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Sero-epidemiological Survey of England in 2019/2020 - COVID-19

NCT04061382 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2963

Last updated 2025-03-20

No results posted yet for this study

Summary

This is a pilot study to assess the feasibility of establishing a national sero-epidemiological survey in England in individuals aged 0-24 years, focusing on assessing humoral immunity against diphtheria, Group C invasive meningococcus and SARS-CoV-2. The investigators will recruit 2800 to 3800 individuals, divided into three groups:

Group one (N= 2300):

This will include all age groups (0-24years), with recruitment restricted by postcodes provided by Public Health England (PHE) to recruit a representative population for the region as assessed by the IMD (Index of Multiple Deprivation scores).

Group two (N= up to 1200):

This group has been added following additional funding to enhance the sample size in response to the COVID-19 pandemic. This will recruit 0-19 year olds and will not be restricted by post code sampling. Instead recruitment will be by public promotion within the normal recruiting regions for each site.

Group three (N= up to 300):

Addition of Group 3 which is enhanced surveillance in participants from Black, Asian or minority ethnic groups (BAME). Since the start of recruitment we have noted that only 11% of participants are from BAME population, despite recruiting in ethnically diverse regions. Given the increased risk of COVID-19 disease in the BAME community, this is a potential limitation of the study as it stands, not only because it may not reflect the diversity of the UK population, but because it does not allow assessment of whether the differing disease rates and seropositivity in adults are reflected in differences in seropositivity rates in children. Similarly to Group 2, this will recruit 0-19 year olds and will not be restricted by post code sampling.

Conditions

  • Serogroup C Meningococcal Meningitis
  • Diphtheria
  • COVID-19

Interventions

PROCEDURE

Venepuncture

One study visit will be conducted by research study staff and blood sampling will be carried out. Up to three follow-up visits will be conducted for a percentage of participants, where additional blood samples will be collected. The blood sample will initially focus on looking at population immunity to diphtheria, group C invasive meningococcal disease and SARS-CoV-2.

PROCEDURE

Oral fluid swab

Saliva sampling will be collected during the follow-up visits. This swab will be collected either by the participant or the participants parent/guardian on the day of the visit. The saliva sampling will primarily be analysed for SARS-CoV-2 antibodies.

Sponsors & Collaborators

  • University of Oxford

    lead OTHER

Principal Investigators

  • Matthew Snape, Professor · University of Oxford

Eligibility

Min Age
1 Day
Max Age
24 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-15
Primary Completion
2021-06-30
Completion
2022-06-14

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04061382 on ClinicalTrials.gov