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Broadening Our Understanding of Early Versus Late Influenza Vaccine Effectiveness

NCT04570904 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 470

Last updated 2022-01-19

No results posted yet for this study

Summary

This study uses a prospective cohort design to investigate if the seasonal influenza vaccine is equally effective when given early and late before the proceeding influenza season. All health care workers will be vaccinated for seasonal influenza either 3 months before or 1 month prior to the start of the influenza season. HCWs that consent to take part in the study will have 4 blood samples taken for an antibody check. The initial antibody checks will be done just prior to vaccination as well as 2 weeks after vaccination. Subsequent samples will be taken at the peak of influenza season and at the end of the influenza season.

HCWs that develop ILI during the course of the influenza season will be asked to complete a questionnaire and oropharyngeal self-swab. HCWs will also provide exhaled breath samples and wear a mask in order to evaluate novel non-invasive methods for diagnosis of influenza.

Influenza positive and negative inpatients identified through the University of Leicester's laboratory system will also be asked to provide breath samples to evaluate this technique for the diagnosis of influenza.

Conditions

Interventions

BIOLOGICAL

Influenza vaccination at different time points

All HCWs will receive the seasonal influenza vaccine but at two different time points.

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    collaborator INDUSTRY

  • World Health Organization

    collaborator OTHER

  • University of Warwick

    collaborator OTHER

  • University Hospitals, Leicester

    collaborator OTHER

  • University of Leicester

    lead OTHER

Principal Investigators

  • Manish Pareek, PhD · University of Leicester

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-28
Primary Completion
2021-05-30
Completion
2021-09-01

Countries

  • United Kingdom

Study Locations

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Diseases
Companies

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 NCT04570904 on ClinicalTrials.gov