A Study to Assess Tolerability of the Trivalent Recombinant Vaccine in Individuals Aged 18 and Ol… (NCT06765187) | Clinical Trial Compass
CompletedNot Applicable
A Study to Assess Tolerability of the Trivalent Recombinant Vaccine in Individuals Aged 18 and Older Using the Vaccinees Perception of Injection Questionnaire
United States1,007 participantsStarted 2024-11-18
Plain-language summary
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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of Participants Reporting Incidence of Reactions (Local) Using Vaccinees' Perception of Injection (VAPI) Questionnaire (Age Groups [18-49 and 50-64 years])
Timeframe: Up to 21 days Post Vaccination
2
Proportion of Participants Reporting Incidence of reactions (Systemic) Using VAPI Questionnaire (Age Groups [18-49 and 50-64 years])
Timeframe: Up to 21 days Post Vaccination
3
Proportion of Participants Reporting Severity of Reactions (Local and Systemic) Using VAPI Questionnaire (Age groups [18-49 and 50-64 years])
Timeframe: Up to 21 days Post Vaccination
4
Vaccine Acceptability Score Using VAPI Questionnaire (Age groups [18-49 and 50-64 years])
Timeframe: Up to 21 days Post Vaccination
5
Impact on Daily Life Activities Score Using VAPI Questionnaire (Age groups [18-49 and 50-64 years])