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Completed

NCT Number: NCT06765187

A Study to Assess Tolerability of the Trivalent Recombinant Vaccine in Individuals Aged 18 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

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Key information

Conditions

Influenza Immunization Health Volunteers Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Investigational site

Swiftwater, Pennsylvania, 18370, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Trivalent Recombinant Influenza Vaccine

Biological

This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice

Primary outcomes

  1. Proportion of Participants Reporting Incidence of Reactions (Local) Using Vaccinees' Perception of Injection (VAPI) Questionnaire (Age Groups [18-49 and 50-64 years])

    Time frame: Up to 21 days Post Vaccination

    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.

  2. Proportion of Participants Reporting Incidence of reactions (Systemic) Using VAPI Questionnaire (Age Groups [18-49 and 50-64 years])

    Time frame: Up to 21 days Post Vaccination

    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.

  3. Proportion of Participants Reporting Severity of Reactions (Local and Systemic) Using VAPI Questionnaire (Age groups [18-49 and 50-64 years])

    Time frame: Up to 21 days Post Vaccination

    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.

  4. Vaccine Acceptability Score Using VAPI Questionnaire (Age groups [18-49 and 50-64 years])

    Time frame: Up to 21 days Post Vaccination

    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.

  5. Impact on Daily Life Activities Score Using VAPI Questionnaire (Age groups [18-49 and 50-64 years])

    Time frame: Up to 21 days Post Vaccination

    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.

Secondary outcomes

  1. Frequencies of Factors Driving Patient Choices of RIV3 Score (Age Group 18-49 and 50-64 years)

    Time frame: At the time of inclusion in the study

    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.

  2. Proportions of factors driving patient choices of RIV3 score

    Time frame: At the time of inclusion in the study

    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.

  3. Proportion of Participants Reporting Incidence of Reactions (Local) Using Vaccinees' Perception of Injection (VAPI) Questionnaire (Age Group 65 years and older)

    Time frame: Up to 21 days Post Vaccination

    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.

  4. Proportion of Participants Reporting Incidence of Reactions (Systemic) Using VAPI Questionnaire (Age Group 65 years and older)

    Time frame: Up to 21 days Post Vaccination

    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.

  5. Proportion of Participants Reporting Severity of Reactions (Local and Systemic) Using VAPI Questionnaire (Age Group 65 years and older)

    Time frame: Up to 21 Days Post Vaccination

    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.

  6. Vaccine Acceptability Score Using VAPI (Age Group 65 years and older)

    Time frame: Up to 21 days Post Vaccination

    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.

  7. Impact on Daily Life Activities Score Using VAPI (Age Group 65 years and older)

    Time frame: Up to 21 Days Post Vaccination

    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.

  8. Frequencies of Factors Driving Patient Choices of RIV3 Score (Age Group 65 years and older)

    Time frame: At the time of inclusion in the study

    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.

  9. Correlation score between EQ-5D-5L and VAPI questionaries

    Time frame: At the time of inclusion in the study

    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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 9, 2025
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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