Clinical trial NCT06765187: 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
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza Immunization
Health Volunteers
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2025-01-09
Enrollment: 447
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Vaccine recipients who meet the inclusion criteria will be recruited from the United States of America (USA) over a period of 3 to 4 months. The study will include a sample of vaccine recipients, called group 1, and will recruit individuals who have received flu vaccine RIV3.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of reactions (local)
timeFrame: At the time of inclusion in the study
measure: Incidence of reactions (systemic)
timeFrame: At the time of inclusion in the study
measure: Severity of reactions (local and systemic)
timeFrame: At the time of inclusion in the study
measure: vaccine acceptability score
timeFrame: At the time of inclusion in the study
measure: impact on daily life activities score
timeFrame: At the time of inclusion in the study
Secondary outcomes:
measure: Frequencies of factors driving patient choices of RIV3 score
timeFrame: At the time of inclusion in the study
measure: Proportions of factors driving patient choices of RIV3 score
timeFrame: At the time of inclusion in the study
measure: Correlation score between EQ-5D-5L and VAPI questionaries
timeFrame: At the time of inclusion in the study
Other outcomes:
Locations:
city: Swiftwater
country: United States
facility: Investigational site
state: Pennsylvania
Study officials:
References: