A Study to Assess Tolerability of the Trivalent Recombinant Vaccine in Individuals Aged 18 and Older Using the Vaccinees Perception of Injection Questionnaire

Cross-sectional Study to Assess Tolerability of the Trivalent Recombinant Influenza Vaccine in Individuals Aged 18 Years and Older Using the Vaccinees Perception of Injection Questionnaire

This study aims to assess patient-reported experiences following trivalent recombinant influenza vaccine (RIV3) vaccination using the Vaccinees' Perception of Injection (VAPI) questionnaire, identify factors related to vaccine choice and future vaccination intentions in each case, and assess the cross-validity of VAPI, by establishing magnitude of correlations to EuroQol 5 Dimensions, 5 Levels (EQ-5D-5L) domains.

Participants will need approximately 30 minutes to complete the self-administered online survey. Individuals will be recruited via a U.S. retail chain partner that offers the RIV3 vaccine as part of their routine influenza vaccination program

Study Overview

• Status: Completed
• Conditions: Influenza Immunization; Health Volunteers
• Intervention / Treatment: Biological: Trivalent Recombinant Influenza Vaccine

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.

In the 2024-2025 influenza season, the sponsor conducted a feasibility study to evaluate patient-reported severity, impact and tolerability of RIV3 local and systemic symptoms, as well as the overall experience of participants with vaccination. The study employed two validated instruments: the EQ-5D-5L and the VAPI , targeting participants aged 18 to 64 years.

For the 2025-2026 influenza season, the study sponsor intends to enhance participant enrollment to enable the generation of statistically robust and clinically meaningful data on the tolerability profile of RIV3. The resulting data are intended for dissemination through peer-reviewed scientific journals and presentation at international scientific conferences.

• Study Type: Observational
• Enrollment (Actual): 1007

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Swiftwater, Pennsylvania, United States, 18370
      • Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

The study will include individuals in the United States who have received the RIV3 vaccine within the past 21 days within a retail setting.

Description

Inclusion Criteria:

• Reside in the United States
• Be able to communicate and read fluently in English (U.S.)
• Have received the RIV3 vaccine within the past 21 days
• Have received the RIV3 vaccine in one of the 35 U.S. states or Washington, D.C., where the recruitment partner pharmacy operates
• Be able to provide explicit informed consent to participate in the study
• Be physically able to participate in a 30-min online survey using an internet-enabled device (e.g., computer, tablet, or smartphone)

Exclusion Criteria:

• Are unable to participate in the online survey
• Have received any other vaccine within the two weeks preceding the study vaccine (RIV3 vaccination); i.e., there must be at least a 2-week interval between the last vaccination and the time of enrollment/study execution
• Have received co-administered vaccinations on the same day as the study vaccine

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Trivalent Recombinant Influenza Vaccine (RIV3)	Biological: Trivalent Recombinant Influenza Vaccine; This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants Reporting Incidence of Reactions (Local) Using Vaccinees' Perception of Injection (VAPI) Questionnaire (Age Groups [18-49 and 50-64 years])	The VAPI questionnaire covers four sections. The first section collects information around pre-vaccination, including motivation, hesitancy, concerns, and routine changes. The second section focuses on the vaccination moment, specifically on vaccination experience regarding pain, anxiety, satisfaction with the vaccination platform, and information received. The third section focuses on post-vaccination experiences. The fourth section captures the overall vaccination experience in terms of tolerability, acceptability, and willingness to be vaccinated in the future.	Up to 21 days Post Vaccination
Proportion of Participants Reporting Incidence of reactions (Systemic) Using VAPI Questionnaire (Age Groups [18-49 and 50-64 years])	The VAPI questionnaire covers four sections. The first section collects information around pre-vaccination, including motivation, hesitancy, concerns, and routine changes. The second section focuses on the vaccination moment, specifically on vaccination experience regarding pain, anxiety, satisfaction with the vaccination platform, and information received. The third section focuses on post-vaccination experiences. The fourth section captures the overall vaccination experience in terms of tolerability, acceptability, and willingness to be vaccinated in the future.	Up to 21 days Post Vaccination
Proportion of Participants Reporting Severity of Reactions (Local and Systemic) Using VAPI Questionnaire (Age groups [18-49 and 50-64 years])	The VAPI questionnaire covers four sections. The first section collects information around pre-vaccination, including motivation, hesitancy, concerns, and routine changes. The second section focuses on the vaccination moment, specifically on vaccination experience regarding pain, anxiety, satisfaction with the vaccination platform, and information received. The third section focuses on post-vaccination experiences. The fourth section captures the overall vaccination experience in terms of tolerability, acceptability, and willingness to be vaccinated in the future.	Up to 21 days Post Vaccination
Vaccine Acceptability Score Using VAPI Questionnaire (Age groups [18-49 and 50-64 years])	The VAPI questionnaire covers four sections. The first section collects information around pre-vaccination, including motivation, hesitancy, concerns, and routine changes. The second section focuses on the vaccination moment, specifically on vaccination experience regarding pain, anxiety, satisfaction with the vaccination platform, and information received. The third section focuses on post-vaccination experiences. The fourth section captures the overall vaccination experience in terms of tolerability, acceptability, and willingness to be vaccinated in the future.	Up to 21 days Post Vaccination
Impact on Daily Life Activities Score Using VAPI Questionnaire (Age groups [18-49 and 50-64 years])	The VAPI questionnaire covers four sections. The first section collects information around pre-vaccination, including motivation, hesitancy, concerns, and routine changes. The second section focuses on the vaccination moment, specifically on vaccination experience regarding pain, anxiety, satisfaction with the vaccination platform, and information received. The third section focuses on post-vaccination experiences. The fourth section captures the overall vaccination experience in terms of tolerability, acceptability, and willingness to be vaccinated in the future.	Up to 21 days Post Vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation score between EQ-5D-5L and VAPI questionaries	By examining the correlation between these domains, the study intends to better understand how perceptions of injection-related adverse effects corelate to broader measures of health-related quality of life, notably those coming from a gold-standard and simpler instrument	At the time of inclusion in the study
Frequencies of Factors Driving Patient Choices of RIV3 Score (Age Group 18-49 and 50-64 years)	VAPI and EuroQol 5 Dimensions, 5 Levels (EQ-5D-5L) questionnaires will be used. The VAPI questionnaire covers four sections. The first section collects information around pre-vaccination, including motivation, hesitancy, concerns, and routine changes. The second section focuses on the vaccination moment, specifically on vaccination experience regarding pain, anxiety, satisfaction with the vaccination platform, and information received. The third section focuses on post-vaccination experiences. The fourth section captures the overall vaccination experience in terms of tolerability, acceptability, and willingness to be vaccinated in the future. The EQ-5D-5L instrument consists of two main components. The first part measures five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The second part includes a visual analogue scale (EQ-VAS) where respondents rate their overall health.	At the time of inclusion in the study
Proportions of factors driving patient choices of RIV3 score	VAPI and EQ-5D-5L questionnaires will be used. The VAPI questionnaire covers four sections. The first section collects information around pre-vaccination, including motivation, hesitancy, concerns, and routine changes. The second section focuses on the vaccination moment, specifically on vaccination experience regarding pain, anxiety, satisfaction with the vaccination platform, and information received. The third section focuses on post-vaccination experiences. The fourth section captures the overall vaccination experience in terms of tolerability, acceptability, and willingness to be vaccinated in the future. The EQ-5D-5L instrument consists of two main components. The first part measures five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The second part includes a visual analogue scale (EQ-VAS) where respondents rate their overall health.	At the time of inclusion in the study
Proportion of Participants Reporting Incidence of Reactions (Local) Using Vaccinees' Perception of Injection (VAPI) Questionnaire (Age Group 65 years and older)	The VAPI questionnaire covers four sections. The first section collects information around pre-vaccination, including motivation, hesitancy, concerns, and routine changes. The second section focuses on the vaccination moment, specifically on vaccination experience regarding pain, anxiety, satisfaction with the vaccination platform, and information received. The third section focuses on post-vaccination experiences. The fourth section captures the overall vaccination experience in terms of tolerability, acceptability, and willingness to be vaccinated in the future.	Up to 21 days Post Vaccination
Proportion of Participants Reporting Incidence of Reactions (Systemic) Using VAPI Questionnaire (Age Group 65 years and older)	The VAPI questionnaire covers four sections. The first section collects information around pre-vaccination, including motivation, hesitancy, concerns, and routine changes. The second section focuses on the vaccination moment, specifically on vaccination experience regarding pain, anxiety, satisfaction with the vaccination platform, and information received. The third section focuses on post-vaccination experiences. The fourth section captures the overall vaccination experience in terms of tolerability, acceptability, and willingness to be vaccinated in the future.	Up to 21 days Post Vaccination
Proportion of Participants Reporting Severity of Reactions (Local and Systemic) Using VAPI Questionnaire (Age Group 65 years and older)	The VAPI questionnaire covers four sections. The first section collects information around pre-vaccination, including motivation, hesitancy, concerns, and routine changes. The second section focuses on the vaccination moment, specifically on vaccination experience regarding pain, anxiety, satisfaction with the vaccination platform, and information received. The third section focuses on post-vaccination experiences. The fourth section captures the overall vaccination experience in terms of tolerability, acceptability, and willingness to be vaccinated in the future.	Up to 21 Days Post Vaccination
Vaccine Acceptability Score Using VAPI (Age Group 65 years and older)	The VAPI questionnaire covers four sections. The first section collects information around pre-vaccination, including motivation, hesitancy, concerns, and routine changes. The second section focuses on the vaccination moment, specifically on vaccination experience regarding pain, anxiety, satisfaction with the vaccination platform, and information received. The third section focuses on post-vaccination experiences. The fourth section captures the overall vaccination experience in terms of tolerability, acceptability, and willingness to be vaccinated in the future.	Up to 21 days Post Vaccination
Impact on Daily Life Activities Score Using VAPI (Age Group 65 years and older)	The VAPI questionnaire covers four sections. The first section collects information around pre-vaccination, including motivation, hesitancy, concerns, and routine changes. The second section focuses on the vaccination moment, specifically on vaccination experience regarding pain, anxiety, satisfaction with the vaccination platform, and information received. The third section focuses on post-vaccination experiences. The fourth section captures the overall vaccination experience in terms of tolerability, acceptability, and willingness to be vaccinated in the future.	Up to 21 Days Post Vaccination
Frequencies of Factors Driving Patient Choices of RIV3 Score (Age Group 65 years and older)	VAPI and EQ-5D-5L questionnaires will be used. The VAPI questionnaire covers four sections. The first section collects information around pre-vaccination, including motivation, hesitancy, concerns, and routine changes. The second section focuses on the vaccination moment, specifically on vaccination experience regarding pain, anxiety, satisfaction with the vaccination platform, and information received. The third section focuses on post-vaccination experiences. The fourth section captures the overall vaccination experience in terms of tolerability, acceptability, and willingness to be vaccinated in the future. The EQ-5D-5L instrument consists of two main components. The first part measures five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The second part includes a visual analogue scale (EQ-VAS) where respondents rate their overall health.	At the time of inclusion in the study

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2024
• Primary Completion (Actual): December 22, 2025
• Study Completion (Actual): December 22, 2025

Study Registration Dates

• First Submitted: December 18, 2024
• First Submitted That Met QC Criteria: January 2, 2025
• First Posted (Actual): January 9, 2025

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Influenza, Human
• Other Study ID Numbers: VAP00035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes