Cross-sectional Study to Assess Tolerability of the Trivalent Recombinant Vaccine in Individuals Between 18 and 64 Years Old Using the Vaccinees Perception of Injection

Sanofi

Status

Completed

Conditions

Health Volunteers

Influenza Immunization

Treatments

Biological: RIV3

Study type

Observational

Funder types

Industry

Identifiers

NCT06765187

VAP00035

Details and patient eligibility

About

This study aims to assess patient-reported experiences post-vaccination with RIV3 using the VAPI instrument, identify drivers for vaccine choice in each case, and assess the cross-validity of VAPI, by establishing magnitude of correlations to EQ-5D-5L domains.

As a feasibility endpoint, this study aims to describe the socio-demographic differences and feasibility of matching between recipients of RIV3 vaccine and mRNA vaccines for COVID-19.

Full description

This study will be conducted through an online survey that respondents will complete only if they meet the inclusion criteria and give their consent to continue to the main questionnaire. Each participant will complete the survey only once. Participants will provide details about their demographic data, health status, perceptions of flu vaccination and injection site reactions, as well as drivers for vaccine choice and future vaccine use.

Enrollment

447 patients

Sex

All

Ages

18 to 64 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Be aged 18-64 years old
50 to 64 years will be the main age group for recruitment
18 to 49 years will allow flexibility to face potential recruitment challenges
Have received a RIV3 vaccine within the last 2 months
Be able to provide explicit consent to participate in the study
Reside in continental US (Puerto Rico is excluded)
Communicate and read fluently in English (US)
Be physically able to participate in a 30 min online survey using an internet-enabled computer or other device (such as a tablet or smartphone)

Exclusion criteria

Inability to participate in survey
Receipt of any other vaccine outside those pre-specified within the past three weeks, and including concomitant vaccination
Receipt of co-administered vaccination