Influenza ImmunizationNCT06765187
A Study to Assess Tolerability of the Trivalent Recombinant Vaccine in Individuals Aged 18 and Older Using the Vaccinees Perception of Injection Questionnaire
An observational study of Influenza Immunization and Health Volunteers, run by Sanofi at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza Immunization, Health Volunteers
- What is being tested?
- Trivalent Recombinant Influenza Vaccine
- Type of treatment
- Vaccines
- How many people
- 1,007 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2024to 22 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Investigational site
Swiftwater, Pennsylvania, 18370
About this study
Official 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
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
Read the 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.
- Conditions
- Influenza Immunization, Health Volunteers
- Being tested
- Trivalent Recombinant Influenza Vaccine
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trivalent Recombinant Influenza VaccineBiological
This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice
| Study group | Role | What they receive |
|---|---|---|
| Trivalent Recombinant Influenza Vaccine (RIV3) | Not described Receives: Biological: Trivalent Recombinant Influenza Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 21 days Post Vaccination
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At the time of inclusion in the study
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
Measured: At the time of inclusion in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start18 Nov 2024
- Primary completion22 Dec 2025
- Study completion22 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza ImmunizationStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,007 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06765187
- Sponsor's protocol ID
- VAP00035
- Status last verified
- Mar 2026
- First submitted
- 18 Dec 2024
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06765187
- Acronym / sponsor ID
- VAP00035
- Conditions
- Influenza Immunization, Health Volunteers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,007 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- 22 Dec 2025 (actual)
- Study completion
- 22 Dec 2025 (actual)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trivalent Recombinant Influenza Vaccine (RIV3) | – | Biological: Trivalent Recombinant Influenza Vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trivalent Recombinant Influenza VaccineThis study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice | Biological | Trivalent Recombinant Influenza Vaccine (RIV3) |
Primary outcome
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.
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.
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.
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.
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.
9 secondary outcomes
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
Proportions of factors driving patient choices of RIV3 score
Time frame: 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)
Time frame: Up to 21 days Post Vaccination
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
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
Vaccine Acceptability Score Using VAPI (Age Group 65 years and older)
Time frame: Up to 21 days Post Vaccination
Impact on Daily Life Activities Score Using VAPI (Age Group 65 years and older)
Time frame: Up to 21 Days Post Vaccination
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
Correlation score between EQ-5D-5L and VAPI questionaries
Time frame: At the time of inclusion in the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza Immunization and Health Volunteers, run by Sanofi at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.