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

RIVET: Re-inventing Influenza Vaccine Efficacy Trials

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN60691705

Enrollment

Registered

2016-10-11

Start date

2016-10-11

Completion date

Unknown

Last updated

2021-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza vaccinations Infections and Infestations Influenza vaccinations

Interventions

Phase 1: Potential participants will be recruited through appropriate charities and local advertisements. The aim is to recruit 6 participants in total. Participants will be asked to c

Eligibility

Sex/Gender

All

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
Phase 1: 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 2. Average length of time of baseline procedure calculated through calculation of the mean time of all baseline visits 3. Acceptability to study staff of baseline procedures is assessed through interviews at the end of all baseline visits 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	—

Measure

Time frame

Phase 1: 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 2. Average length of time of baseline procedure calculated through calculation of the mean time of all baseline visits 3. Acceptability to study staff of baseline procedures is assessed through interviews at the end of all baseline visits 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

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Secondary

Measure	Time frame
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 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.	—

Measure

Time frame

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 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.

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Countries

United Kingdom

Contacts

Public ContactSarah Tearne

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026