InfluenzaNCT07871448
Flu COVID Vaccine Views
An observational study of Influenza and COVID-19, run by George Washington University at 2 sites in United States.
Trial summary
This study addresses a critical evidence gap relevant to implementation strategies for combination vaccines in health care settings. This study will specifically investigate healthcare worker (HCWs) attitudes around and willingness to receive combination influenza/COVID-19 vaccines. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, COVID-19, Vaccination Willingness
- What is being tested?
- Survey
- Type of treatment
- Vaccines
- How many people
- 550 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2026to 1 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthcare workers who are eligible for seasonal influenza vaccination, encompassing both clinical and non-clinical positions (physicians, advanced practice providers, nurses, allied health professionals, administrative and support staff, trainees, and students). We are targeting enrollment of 275 participants per site (George Washington University and Children's National Hospital), for a study-wide total of 550.
Who may be able to join
- Age 18-89 years old
- Currently employed or enrolled as a student at GWU, GW MFA or CNH
- Eligible for institutional influenza vaccination
- Able to complete the survey in English
Who cannot join
- On long-term leave at the time of survey launch
- Contractors without institutional email access
- Contraindication to receiving influenza vaccination
- Contraindication to receiving COVID-19 vaccination
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Annie Roberts contact
United States2 sites
Children's National Hospital
Washington D.C., District of Columbia, 20020
Sarah Schaffer DeRoo, MD, 202-545-2900, sschafferd@childrensnational.org
Sarah Schaffer DeRoo, MD
George Washington University
Washington D.C., District of Columbia, 20037
Annie Roberts, 610-283-4402, annieroberts@email.gwu.edu
ddiemert@email.gwu.edu
About this study
Official title: Factors Driving Willingness to Receive Influenza, COVID-19, and Combination Influenza/COVID-19 Vaccines Among Health Care Workers
This study addresses a critical evidence gap relevant to implementation strategies for combination vaccines in health care settings. This study will specifically investigate healthcare worker (HCWs) attitudes around and willingness to receive combination influenza/COVID-19 vaccines. Findings will identify determinants of hesitancy and acceptance among HCWs and support effective rollout strategies and communication approaches. Cross-sectional surveys and qualitative interviews will be conducted with healthcare workers to characterize HCW willingness to be vaccinated and to identify demographic, attitudinal, and structural predictors of vaccination.
Read the detailed description
This study uses a sequential explanatory mixed-methods design. The first phase utilizes a cross-sectional, multi-site electronic survey. The quantitative survey will characterize willingness of approximately 550 HCWs to receive a combination influenza/COVID-19 vaccine and to identify demographic, attitudinal, and structural predictors of vaccination. Participants will complete a one-time REDCap survey (approximately 20-30 minutes).
In the second phase, a subset of 10-20 HCWs will be invited to participate in qualitative interviews that will be used to interpret and elaborate on quantitative findings. Specifically, the qualitative analysis allows for exploration of the nuanced rationale behind reported willingness to vaccinate, gives additional context to latent constructs identified in factor analysis, and identifies communication preferences that are not adequately captured by closed-ended questions. Integration will occur at the interpretation stage: quantitative results will inform purposive sampling for the qualitative phase, and qualitative themes will be used to contextualize and explain patterns observed in the quantitative analysis. A joint display table will be used in reporting to show how qualitative findings confirm, extend, or challenge quantitative results.
- Conditions
- Influenza, COVID-19, Vaccination Willingness
- Being tested
- Survey
- Medical subject headings
- Influenza, Human, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
One-time RedCAP electronic survey on the willingness of healthcare workers to receive a combination influenza/COVID-19 vaccine and factors that might influence this decision.
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of health care workers (HCWs) who indicate that they would "definitely" or "probably" receive a combination influenza and COVID-19 vaccine.
Measured: Day 1
Secondary outcomes (7)
Proportion of HCWs willing to receive standalone seasonal influenza vaccines.
Measured: Day 1
Proportion of HCWs willing to receive standalone COVID-19 vaccines, also stratified by COVID-19 vaccine platform (mRNA vs. protein-based).
Measured: Day 1
Determinants of willingness to receive combination influenza and COVID-19 vaccines as assessed by multivariable logistic regression.
Adjusted odds ratios (aOR) for demographic, occupational, behavioral, attitudinal, and emotional predictors associated with vaccination willingness, measured using responses from the REDCap electronic survey.
Measured: Day 1
Categorization of attitudes toward co-administration compared with true combination vaccine formulations as assessed by semi-structured qualitative interviews.
Qualitative thematic analysis of healthcare worker attitudes and preferences recorded using a semi-structured qualitative interview guide.
Measured: Day 1 through completion of the qualitative surveys, an average of 1 month.
Participant ranking of messaging options associated with willingness to receive combination vaccines as assessed by REDCap survey.
Mean ranking scores of communication messaging options measured via ordinal ranking items in the REDCap electronic survey.
Measured: Day 1 through completion of the qualitative surveys, an average of 1 month.
Proportion of participants in different thematic categories regarding concerns, motivations, and preferred communication strategies as assessed by qualitative thematic analysis.
Identified qualitative themes and sub-themes synthesized using qualitative thematic analysis from REDCap survey free-text fields and semi-structured interview transcripts.
Measured: Day 1 through completion of the qualitative surveys, an average of 1 month.
Proportion of participants in different thematic categories associated with willingness to receive combination vaccines as assessed by semi-structured qualitative interviews.
Qualitative themes identified through inductive thematic analysis of semi-structured interview transcripts.
Measured: Day 1 through completion of the qualitative surveys, an average of 1 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi Pasteur, a Sanofi Company
- Responsible party
- Principal investigator, Daniel Park, George Washington University
- Investigators
- Daniel Park, PhD, Principal investigator, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07871448
- Sponsor's protocol ID
- VBA511
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Driving Willingness to Receive Influenza, COVID-19, and Combination Influenza/COVID-19 Vaccines Among Health Care Workers
- ClinicalTrials.gov ID
- NCT07871448
- Acronym / sponsor ID
- VBA511
- Conditions
- Influenza, COVID-19, Vaccination Willingness
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Collaborators
- Sanofi Pasteur, a Sanofi Company
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 13 Oct 2026 (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 addresses a critical evidence gap relevant to implementation strategies for combination vaccines in health care settings. This study will specifically investigate healthcare worker (HCWs) attitudes around and willingness to receive combination influenza/COVID-19 vaccines. Findings will identify determinants of hesitancy and acceptance among HCWs and support effective rollout strategies and communication approaches. Cross-sectional surveys and qualitative interviews will be conducted with healthcare workers to characterize HCW willingness to be vaccinated and to identify demographic, attitudinal, and structural predictors of vaccination.
Detailed description
This study uses a sequential explanatory mixed-methods design. The first phase utilizes a cross-sectional, multi-site electronic survey. The quantitative survey will characterize willingness of approximately 550 HCWs to receive a combination influenza/COVID-19 vaccine and to identify demographic, attitudinal, and structural predictors of vaccination. Participants will complete a one-time REDCap survey (approximately 20-30 minutes).
In the second phase, a subset of 10-20 HCWs will be invited to participate in qualitative interviews that will be used to interpret and elaborate on quantitative findings. Specifically, the qualitative analysis allows for exploration of the nuanced rationale behind reported willingness to vaccinate, gives additional context to latent constructs identified in factor analysis, and identifies communication preferences that are not adequately captured by closed-ended questions. Integration will occur at the interpretation stage: quantitative results will inform purposive sampling for the qualitative phase, and qualitative themes will be used to contextualize and explain patterns observed in the quantitative analysis. A joint display table will be used in reporting to show how qualitative findings confirm, extend, or challenge quantitative results.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthcare workers who are eligible for seasonal influenza vaccination, encompassing both clinical and non-clinical positions (physicians, advanced practice providers, nurses, allied health professionals, administrative and support staff, trainees, and students). We are targeting enrollment of 275 participants per site (George Washington University and Children's National Hospital), for a study-wide total of 550.
Key inclusion criteria (4 listed)
- Age 18-89 years old
- Currently employed or enrolled as a student at GWU, GW MFA or CNH
- Eligible for institutional influenza vaccination
- Able to complete the survey in English
Key exclusion criteria (4 listed)
- On long-term leave at the time of survey launch
- Contractors without institutional email access
- Contraindication to receiving influenza vaccination
- Contraindication to receiving COVID-19 vaccination
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 |
|---|---|---|
| SurveyOne-time RedCAP electronic survey on the willingness of healthcare workers to receive a combination influenza/COVID-19 vaccine and factors that might influence this decision. | Other | – |
Primary outcome
Proportion of health care workers (HCWs) who indicate that they would "definitely" or "probably" receive a combination influenza and COVID-19 vaccine.
Time frame: Day 1
7 secondary outcomes
Proportion of HCWs willing to receive standalone seasonal influenza vaccines.
Time frame: Day 1
Proportion of HCWs willing to receive standalone COVID-19 vaccines, also stratified by COVID-19 vaccine platform (mRNA vs. protein-based).
Time frame: Day 1
Determinants of willingness to receive combination influenza and COVID-19 vaccines as assessed by multivariable logistic regression.
Time frame: Day 1
Categorization of attitudes toward co-administration compared with true combination vaccine formulations as assessed by semi-structured qualitative interviews.
Time frame: Day 1 through completion of the qualitative surveys, an average of 1 month.
Participant ranking of messaging options associated with willingness to receive combination vaccines as assessed by REDCap survey.
Time frame: Day 1 through completion of the qualitative surveys, an average of 1 month.
Proportion of participants in different thematic categories regarding concerns, motivations, and preferred communication strategies as assessed by qualitative thematic analysis.
Time frame: Day 1 through completion of the qualitative surveys, an average of 1 month.
Proportion of participants in different thematic categories associated with willingness to receive combination vaccines as assessed by semi-structured qualitative interviews.
Time frame: Day 1 through completion of the qualitative surveys, an average of 1 month.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
Annie Roberts contact
Daniel Park, PhD principal investigator
George Washington University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza and COVID-19, run by George Washington University at 2 sites 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 4 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: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Park, PhD (202-994-0218, danpark@email.gwu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of health care workers (HCWs) who indicate that they would "definitely" or "probably" receive a combination influenza and COVID-19 vaccine. (time frame: Day 1). 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 13 Oct 2026.