NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Broadening Our Understanding of Early Versus Late Influenza Vaccine Effectiveness
Broadening Our Understanding of Early Versus Late Influenza Vaccine Effectiveness

NCT04570904

CompletedN/A

Sponsor: University of Leicester

Conditions: Influenza, Influenza -Like Illness

Interventions: Influenza vaccination at different time points

Countries: United Kingdom

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.

Eligibility overview

Sex: ALL

Age: 16 Years to

Healthy volunteers: Yes

Study type: OBSERVATIONAL

Eligibility criteria
Inclusion Criteria:

For Health care workers (HCWs)

* Willing and able to give informed consent
* Employee at the University Hospitals of Leicester
* Willing and able to have the inactivated Influenza vaccine
* Age ≥16 For inpatients
* Inpatient at University Hospitals of Leicester
* Throat swab for influenza completed in the last 72 hours
* Willing and able to give informed consent
* Well enough to provide an exhaled breath sample without causing distress or discomfort
* Well enough to wear a face mask without causing distress or discomfort
* Age ≥16

Exclusion Criteria:

* Age \<16
* Unwilling and/or unable to give informed written consent
Locations (1)
  • Leicester, Leicestershire, United Kingdom