A pilot study to determine the feasibility and acceptability of the recruitment and follow-up procedures planned for a large scale study (phase IIb) of a novel influenza vaccine

Not Applicable

Completed

• Conditions: Influenza vaccinations; Infections and Infestations

• Registration Number: ISRCTN60691705
• Lead Sponsor: Vaccitech

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-11
• Study Completion: 2017-10-01
• Last Update Posted: 3 May 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

1. Willing and has capacity to provide written informed consent for participation in the study and to comply with all study requirements (in the Investigator’s opinion)
2. Male or female adults, aged 65 years or above
3. Eligible to receive seasonal influenza vaccine

Exclusion Criteria

1. Ongoing terminal illness with a life expectancy of <6 months
2. Any other significant disease, which, in the opinion of the Investigators, would put at risk their ability to comply with the study procedures
3. Have already received the annual seasonal influenza vaccine (Phase 2 participants only)

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Phase 1:<br> 1. Acceptability to participants of baseline procedures is assessed through a focus group at the end of the baseline visit with all those who took part in phase 1<br> 2. Average length of time of baseline procedure calculated through calculation of the mean time of all baseline visits<br> 3. Acceptability to study staff of baseline procedures is assessed through interviews at the end of all baseline visits<br> 4. Data entry errors will be counted to provide an overall total at the end of the baseline visit. In addition frequency of errors will be calculated for each data point<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Acceptability to participants of follow up methods is assessed through interviews at the end of the follow up period with all phase 2 participants<br> 2. Completeness of diary entry will be assessed through reviewing all missing data. Frequency of missing data across the whole cohort will be calculated for each data point where data was missed. This will take place at the end of the follow up period.<br>