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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 1,007
- 试验地点
- 1
- 主要终点
- Proportion of Participants Reporting Incidence of Reactions (Local) Using Vaccinees' Perception of Injection (VAPI) Questionnaire (Age Groups [18-49 and 50-64 years])
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
Trivalent Recombinant Influenza Vaccine (RIV3)
干预措施: Trivalent Recombinant Influenza Vaccine (Biological)
结局指标
主要结局
Proportion of Participants Reporting Incidence of Reactions (Local) Using Vaccinees' Perception of Injection (VAPI) Questionnaire (Age Groups [18-49 and 50-64 years])
时间窗: 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.
Proportion of Participants Reporting Incidence of reactions (Systemic) Using VAPI Questionnaire (Age Groups [18-49 and 50-64 years])
时间窗: 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.
Proportion of Participants Reporting Severity of Reactions (Local and Systemic) Using VAPI Questionnaire (Age groups [18-49 and 50-64 years])
时间窗: 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.
Vaccine Acceptability Score Using VAPI Questionnaire (Age groups [18-49 and 50-64 years])
时间窗: 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.
Impact on Daily Life Activities Score Using VAPI Questionnaire (Age groups [18-49 and 50-64 years])
时间窗: 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.
次要结局
- Frequencies of Factors Driving Patient Choices of RIV3 Score (Age Group 18-49 and 50-64 years)(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)(Up to 21 days Post Vaccination)
- Proportion of Participants Reporting Incidence of Reactions (Systemic) Using VAPI Questionnaire (Age Group 65 years and older)(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)(Up to 21 Days Post Vaccination)
- Vaccine Acceptability Score Using VAPI (Age Group 65 years and older)(Up to 21 days Post Vaccination)
- Impact on Daily Life Activities Score Using VAPI (Age Group 65 years and older)(Up to 21 Days Post Vaccination)
- Frequencies of Factors Driving Patient Choices of RIV3 Score (Age Group 65 years and older)(At the time of inclusion in the study)
- Proportions of factors driving patient choices of RIV3 score(At the time of inclusion in the study)
- Correlation score between EQ-5D-5L and VAPI questionaries(At the time of inclusion in the study)