InfluenzaPhase 4NCT06020118

Comparative Immunogenicity of Concomitant vs Sequential mRNA COVID-19 and Influenza Vaccinations

A Phase 4 study testing Simultaneous Vaccination (Influenza Vaccine and mRNA COVID booster), Sequential Vaccination (Influenza vaccine then mRNA COVID booster) and Sequential Vaccination (mRNA COVID booster then Influenza vaccine) in people with Influenza and COVID-19, run by Duke University at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a prospective, randomized randomized immunologic study of response to influenza and SARS-CoV-2 vaccination across four of the US Influenza Vaccine Effectiveness (Flu VE) Network study sites. Read more about this study

Who is it for?: Ages 6 to 64 yearsHealthy volunteers can take part
Conditions the study is for: Influenza, COVID-19
What is being tested?: Simultaneous Vaccination (Influenza Vaccine and mRNA COVID booster), Sequential Vaccination (Influenza vaccine then mRNA COVID booster) and Sequential Vaccination (mRNA COVID booster then Influenza vaccine)
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 455 participants
Where: 8 sitesUnited States
Study dates: 25 Sep 2023to 17 May 2024
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 6 to 64 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Healthy children aged 6-11 years and healthy adults aged 18-64 years that have not received the current season's influenza vaccination or a mRNA COVID-19 vaccination in the past 6 months and have already completed at least a two-dose primary series of an mRNA COVID-19 vaccination
English or Spanish literate
Email or text message capability for weekly follow-up
Intention of receiving influenza vaccine and mRNA COVID-19 vaccine based on ACIP-CDC guidelines
Willing to provide written/electronic informed consent
Intention of being available for entire study period and able to complete all relevant study procedures, including follow-up phone calls and clinic visits

Who cannot join

Self-reported COVID-19 infection within 3 months prior to enrollment
Received COVID-19 vaccine within 6 months prior to enrollment
Received influenza vaccine during the respective influenza season in which the participants are being enrolled
< 9 years of age and recommended to receive two doses of IIV4 during the respective influenza season in which they are being enrolled
History of severe allergic reaction after a previous dose of any influenza or COVID-19 mRNA vaccine; or to an influenza or COVID-19 mRNA vaccine component
Receipt of any licensed vaccine within 6 weeks prior to enrollment in this study or planning receipt of any vaccines within 4 weeks after the receipt of the second vaccine dose administered during study procedures

Show all 18Show fewer

Has an immunocompromising condition or taking immunosuppressive medication*
Received oral, intramuscular or intravenous systemic immunosuppressants, or immune modifying drugs for >14 days in total within 6 months prior to any study vaccine dose (for corticosteroids ≥ 20 mg/day of prednisone equivalent).
Note: Topical medications are allowed
Received immunoglobulin, SARS-CoV-2 immunoglobulin, SARS-CoV-2 monoclonal antibody, or blood-derived products, within 3 months prior any study vaccine dose.
History of Guillain-Barré syndrome
History of myocarditis or pericarditis
History of multisystem inflammatory syndrome in children (MIS-C) or adults (MIS-A)
Currently pregnant, planning to become pregnant within the first three months of the study per participant self-report or likely to be pregnant per screening criteria
Bleeding disorder diagnosed by a healthcare provider or bleeding difficulties with intramuscular injections or blood draws.
Has injury or other reason why deltoid site on both arms cannot be used for vaccinations
Any condition which, in the opinion of the investigators, may pose a health risk to the participant or interfere with the evaluation of the study objectives
Temporary Delay Criteria: History of febrile illness (> 100.0°F or 37.8°C) within the past 72 hours prior to vaccine administration

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

Centers for Disease Control and Prevention
Atlanta, Georgia, 30333
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
VA Northeast Ohio Healthcare System (VANEOHS)
Cleveland, Ohio, 44106
Valleywise Health Comprehensive Health Center
Phoenix, Arizona, 85008
Department of Family Medicine, University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, 15260
Senders Pediatrics
South Euclid, Ohio, 44121
Washington University IDCRU
St Louis, Missouri, 63110
ASU Biodesign Institute
Tempe, Arizona, 85281

Other trials in United States

About this study

Official title: Randomized Study of the Immunogenicity and Duration of Antibody Response Against Circulating SARS-CoV-2 Variant and Influenza Viruses Following Concomitant Versus Sequential Administration of mRNA COVID-19 Vaccine and Quadrivalent Cell Culture-based Influenza Vaccine Among Children and Adults

This is a prospective, randomized randomized immunologic study of response to influenza and SARS-CoV-2 vaccination across four of the US Influenza Vaccine Effectiveness (Flu VE) Network study sites.

Read the detailed description

This study is a prospective, randomized comparative immunogenicity study in an enrolled cohort. During this study, eligible participants will be randomly assigned to receive an approved quadrivalent cell culture-based influenza vaccine (ccIIV4, Seqirus) and an approved mRNA COVID-19 vaccine (Moderna) either concomitantly or sequentially, 28 days apart. Participants (aged 6-11 years and 18-64 years) will be enrolled in the 2023-2024 influenza season.

Demographic and health data (including influenza and COVID-19 vaccination and infection history) will be collected upon enrollment. Enrolled participants will be randomized to one of the following interventions (2:1:1) (i) concomitant administration of the mRNA COVID-19 vaccine (Moderna) and quadrivalent influenza vaccine (ccIIV4, Seqirus); (ii)sequential administration of the quadrivalent influenza vaccine (ccIIV4, Seqirus) at Visit 1 (day 0) and the mRNA COVID-19 vaccine(Moderna) at Visit 2 (day 28); (iii) sequential administration of the mRNA COVID-19 vaccine (Moderna) at Visit 1 (day 0) followed by the quadrivalent influenza vaccine (ccIIV4, Seqirus) at Visit 2 (day 28). Participants will not be blinded to vaccine group.

Whole blood samples to isolate sera for immune assays will be collected prior to vaccination administration at Visit 1 (day 0), Visit 2 (day 28) Visit 3 (day 56; post-vaccination 2) and Visit 4 (day180; end of local flu circulation). Blood samples to isolate PBMC and plasma will be collected from a subset of 250 participants (200 adults and 50 children). If participants exhibit ARI during the study period, the participants may be asked to present for collection of a nasal swab for viral testing for acute influenza or SARS-CoV-2 infection (within 10 days after symptom onset), and blood specimen to isolate sera for immune assays. For participants with confirmed acute infection, the participants may be asked to present for collection of a convalescent-phase blood specimen approximately 28 days after acute visit for isolation of sera, PBMC and plasma.

Conditions: Influenza, COVID-19
Being tested: Simultaneous Vaccination (Influenza Vaccine and mRNA COVID booster), Sequential Vaccination (Influenza vaccine then mRNA COVID booster), Sequential Vaccination (mRNA COVID booster then Influenza vaccine)
Keywords: Influenza, COVID-19, Immunogencity, Health, Reactogenicity
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.

Simultaneous Vaccination (Influenza Vaccine and mRNA COVID booster)Biological
Influenza vaccination and mRNA COVID-19 booster will be given at Visit 1.
Sequential Vaccination (Influenza vaccine then mRNA COVID booster)Biological
Influenza vaccine will be given at Visit 1 and mRNA COVID booster will be given at Visit 2.
Sequential Vaccination (mRNA COVID booster then Influenza vaccine)Biological
mRNA COVID booster will be given at Visit 1 and Influenza vaccine will be given at Visit 2.

Study groups in NCT06020118
Study group	Role	What they receive
Group i: Concomitant Vaccination	Experimental	Concomitant Vaccination (Influenza vaccine and mRNA COVID booster) at Visit 1 Receives: Biological: Simultaneous Vaccination (Influenza Vaccine and mRNA COVID booster)
Group ii: Influenza Vaccination at Visit 1	Experimental	Sequential vaccination with Influenza vaccination at Visit 1 and mRNA COVID booster at Visit 2 Receives: Biological: Sequential Vaccination (Influenza vaccine then mRNA COVID booster)
Group iii: mRNA COVID-19 Vaccination at Visit 1	Experimental	Sequential vaccination with mRNA COVID booster at Visit 1 and Influenza vaccination at Visit 2 Receives: Biological: Sequential Vaccination (mRNA COVID booster then Influenza vaccine)

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With HAI Seroconversion
Number of participants with a seroconversion HAI Titer ≥1:40 at Day 29 if Day 1 titer is <1:10 or a four-fold rise at Day 29 if Day 1 titer is ≥1:10 for each ccIIV4 antigen in the 2023-2024 influenza season.
Measured: Visit 1 (day 1; baseline) to Visit 2 (days 28-42; post-vaccination) for all arms/groups
Percentage of Participants With HAI Seroprotection
Number of participants with a seroprotective HAI titer (≥ 1:40) pre- and post-immunization at day 29 for each ccIIV4 antigen in the 2023-2024 influenza season.
Measured: Visit 1 (day 1; baseline; pre-immunization) and Visit 2 (days 28-42; post-immunization) for all arms/groups
HAI Geometric Mean Titer
The geometric mean HAI titer (GMT) for each ccIIV4 antigen in the 2023-2024 influenza season. GMTs were derived by using the anti-log of the mean of the log transformed titers.
Measured: Visit 1 (day 1; baseline; pre-immunization) and Visit 2 (days 28-42; post-immunization) for all arms/groups
HAI Geometric Mean Fold Rise (GMFR)
GMFRs and 95% confidence intervals were calculated using a t-distribution on log 2-transformed titers.
Measured: Visit 1 (day 1; baseline) to Visit 2 (days 28-42; post-vaccination) for all arms/groups

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Sep 202317 May 2024

First posted31 Aug 2023
Study start25 Sep 2023
Primary completion7 Mar 2024
Study completion17 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for InfluenzaStudies of the same condition, open and under way.
More trials run by Duke UniversityThe 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: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 455 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06020118
Sponsor's protocol ID: Pro00113674
Status last verified: Jun 2025
First submitted: 30 Aug 2023
Last updated: 13 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Study of the Immunogenicity and Duration of Antibody Response Against Circulating SARS-CoV-2 Variant and Influenza Viruses Following Concomitant Versus Sequential Administration of mRNA COVID-19 Vaccine and Quadrivalent Cell Culture-based Influenza Vaccine Among Children and Adults
ClinicalTrials.gov ID: NCT06020118
Acronym / sponsor ID: Pro00113674
Conditions: Influenza, COVID-19
Keywords: Influenza, COVID-19, Immunogencity, Health, Reactogenicity
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 455 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Collaborators: Centers for Disease Control and Prevention, Arizona State University, University Hospitals Cleveland Medical Center, University of Pittsburgh, Washington University School of Medicine, Valleywise Health, Cleveland VA Medical Center, Senders Pediatrics
Study start: 25 Sep 2023 (actual)
Primary completion: 7 Mar 2024 (actual)
Study completion: 17 May 2024 (actual)
First posted: 31 Aug 2023 (actual)
Results: Posted 13 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a prospective, randomized randomized immunologic study of response to influenza and SARS-CoV-2 vaccination across four of the US Influenza Vaccine Effectiveness (Flu VE) Network study sites.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Group i: Concomitant Vaccination	Experimental	Biological: Simultaneous Vaccination (Influenza Vaccine and mRNA COVID booster)Concomitant Vaccination (Influenza vaccine and mRNA COVID booster) at Visit 1
Group ii: Influenza Vaccination at Visit 1	Experimental	Biological: Sequential Vaccination (Influenza vaccine then mRNA COVID booster)Sequential vaccination with Influenza vaccination at Visit 1 and mRNA COVID booster at Visit 2
Group iii: mRNA COVID-19 Vaccination at Visit 1	Experimental	Biological: Sequential Vaccination (mRNA COVID booster then Influenza vaccine)Sequential vaccination with mRNA COVID booster at Visit 1 and Influenza vaccination at Visit 2

Who may qualify

Ages: 6 to 64 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (6 listed)

Healthy children aged 6-11 years and healthy adults aged 18-64 years that have not received the current season's influenza vaccination or a mRNA COVID-19 vaccination in the past 6 months and have already completed at least a two-dose primary series of an mRNA COVID-19 vaccination
English or Spanish literate
Email or text message capability for weekly follow-up
Intention of receiving influenza vaccine and mRNA COVID-19 vaccine based on ACIP-CDC guidelines
Willing to provide written/electronic informed consent

Key exclusion criteria (18 listed)

Self-reported COVID-19 infection within 3 months prior to enrollment
Received COVID-19 vaccine within 6 months prior to enrollment
Received influenza vaccine during the respective influenza season in which the participants are being enrolled
< 9 years of age and recommended to receive two doses of IIV4 during the respective influenza season in which they are being enrolled
History of severe allergic reaction after a previous dose of any influenza or COVID-19 mRNA vaccine; or to an influenza or COVID-19 mRNA vaccine component

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
Simultaneous Vaccination (Influenza Vaccine and mRNA COVID booster)Influenza vaccination and mRNA COVID-19 booster will be given at Visit 1.	Biological	Group i: Concomitant Vaccination
Sequential Vaccination (Influenza vaccine then mRNA COVID booster)Influenza vaccine will be given at Visit 1 and mRNA COVID booster will be given at Visit 2.	Biological	Group ii: Influenza Vaccination at Visit 1
Sequential Vaccination (mRNA COVID booster then Influenza vaccine)mRNA COVID booster will be given at Visit 1 and Influenza vaccine will be given at Visit 2.	Biological	Group iii: mRNA COVID-19 Vaccination at Visit 1

Primary outcome

Percentage of Participants With HAI Seroconversion
Time frame: Visit 1 (day 1; baseline) to Visit 2 (days 28-42; post-vaccination) for all arms/groups
Number of participants with a seroconversion HAI Titer ≥1:40 at Day 29 if Day 1 titer is <1:10 or a four-fold rise at Day 29 if Day 1 titer is ≥1:10 for each ccIIV4 antigen in the 2023-2024 influenza season.
Percentage of Participants With HAI Seroprotection
Time frame: Visit 1 (day 1; baseline; pre-immunization) and Visit 2 (days 28-42; post-immunization) for all arms/groups
Number of participants with a seroprotective HAI titer (≥ 1:40) pre- and post-immunization at day 29 for each ccIIV4 antigen in the 2023-2024 influenza season.
HAI Geometric Mean Titer
Time frame: Visit 1 (day 1; baseline; pre-immunization) and Visit 2 (days 28-42; post-immunization) for all arms/groups
The geometric mean HAI titer (GMT) for each ccIIV4 antigen in the 2023-2024 influenza season. GMTs were derived by using the anti-log of the mean of the log transformed titers.
HAI Geometric Mean Fold Rise (GMFR)
Time frame: Visit 1 (day 1; baseline) to Visit 2 (days 28-42; post-vaccination) for all arms/groups
GMFRs and 95% confidence intervals were calculated using a t-distribution on log 2-transformed titers.

Results and safety

Results posted to the registry on 13 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group i: Concomitant Vaccination at Visit 1	223	219
Group ii: Influenza Vaccination at Visit 1	111	102
Group Iii: mRNA COVID-19 Vaccination at Visit 1	113	111

Primary outcome: Percentage of Participants With HAI Seroconversion

Time frame: Visit 1 (day 1; baseline) to Visit 2 (days 28-42; post-vaccination) for all arms/groups. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Group i n = 197	Group ii n = 95	Group Iii n = 107
A(H1N1)pdm09	53.3 (46.1 to 60.4)	52.6 (42.1 to 63.0)	0.9 (0.02 to 5.1)
A(H3N2)	33.5 (27.0 to 40.6)	36.8 (27.2 to 47.4)	1.9 (0.2 to 6.6)
B/Victoria	47.7 (40.6 to 54.9)	48.4 (38.0 to 58.9)	4.7 (1.5 to 10.6)
B/Yamagata	18.8 (13.6 to 25.0)	14.7 (8.3 to 23.5)	1.9 (0.2 to 6.6)

Group i vs Group ii: p = 0.938, Regression, Logistic
Group i vs Group ii: p = 0.451, Regression, Logistic
Group i vs Group ii: p = 0.819, Regression, Logistic

Population analysed: Influenza Immunogenicity Population: Subset of the modified intention-to-treat (mITT) Population that includes only subjects who received both vaccines, provide visit 1 and visit 2 blood draws available with HAI titer results for analysis within the protocol-defined time frame, did not have an influenza or SARS-CoV-2 infection between visits 1 and 2, and had no protocol violations affecting immunogenicity.

Primary outcome: Percentage of Participants With HAI Seroprotection

Time frame: Visit 1 (day 1; baseline; pre-immunization) and Visit 2 (days 28-42; post-immunization) for all arms/groups. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Group i n = 197	Group ii n = 95	Group Iii n = 107
A(H1N1)pdm09	88.3 (83.0 to 92.5)	87.4 (79.0 to 93.3)	58.9 (49.0 to 68.3)
A(H3N2)	71.1 (64.2 to 77.3)	80.0 (70.5 to 87.5)	36.5 (27.4 to 46.3)
B/Victoria	84.3 (78.4 to 89.1)	85.3 (76.5 to 91.7)	38.3 (29.1 to 48.2)
B/Yamagata	95.4 (91.5 to 97.9)	97.9 (92.6 to 99.7)	87.8 (80.2 to 93.4)

Group i vs Group ii: p = 0.894, Regression, Logistic
Group i vs Group ii: p = 0.104, Regression, Logistic
Group i vs Group ii: p = 0.815, Regression, Logistic

Population analysed: Influenza Immunogenicity Population: Subset of the mITT Population that includes only subjects who received both vaccines, provide visit 1 and visit 2 blood draws available with HAI titer results for analysis within the protocol-defined time frame, did not have an influenza or SARS-CoV-2 infection between visits 1 and 2, and had no protocol violations affecting immunogenicity.

Primary outcome: HAI Geometric Mean Titer

Time frame: Visit 1 (day 1; baseline; pre-immunization) and Visit 2 (days 28-42; post-immunization) for all arms/groups. Geometric mean (95% Confidence Interval). Unit: Titer

Measure	Group i n = 197	Group ii n = 95	Group Iii n = 107
Pre-vaccine: A(H1N1)pdm09	31.7 (25.8 to 38.8)	33.6 (24.9 to 45.2)	34.1 (26.6 to 43.8)
Post-vaccine: A(H1N1)pdm09	148.3 (122.6 to 179.5)	146.6 (110.5 to 194.5)	34.5 (27.0 to 44.0)
Pre-vaccine: A(H3N2)	20.9 (17.1 to 25.4)	22.5 (16.8 to 30.0)	21.3 (16.3 to 28.0)
Post-vaccine: A(H3N2)	58.5 (47.0 to 72.8)	72.0 (54.6 to 94.8)	21.7 (16.6 to 28.4)
Pre-vaccine: B/Victoria	24.9 (20.6 to 30.0)	29.3 (22.9 to 37.7)	22.0 (17.2 to 28.3)
Post-vaccine: B/Victoria	103.8 (85.7 to 125.6)	120.4 (94.3 to 153.7)	24.4 (19.3 to 31.0)
Pre-vaccine: B/Yamagata	119.3 (100.6 to 141.4)	143.4 (114.7 to 179.3)	107.4 (86.1 to 134.0)
Post-vaccine: B/Yamagata	223.9 (193.4 to 259.2)	245.2 (203.8 to 295.0)	110.6 (89.1 to 137.3)

Group i vs Group ii: p = 0.699, Regression, Linear
Group i vs Group ii: p = 0.880, Regression, Linear
Group i vs Group ii: p = 0.720, Regression, Linear

Primary outcome: HAI Geometric Mean Fold Rise (GMFR)

Time frame: Visit 1 (day 1; baseline) to Visit 2 (days 28-42; post-vaccination) for all arms/groups. Mean (95% Confidence Interval). Unit: Fold Change

Measure	Group i n = 197	Group ii n = 95	Group Iii n = 107
A(H1N1)pdm09	4.7 (3.8 to 5.8)	4.4 (3.3 to 5.7)	1.0 (0.9 to 1.1)
A(H3N2)	2.8 (2.3 to 3.4)	3.2 (2.5 to 4.2)	1.0 (0.9 to 1.1)
B/Victoria	4.2 (3.5 to 5.0)	4.1 (3.2 to 5.3)	1.1 (1.0 to 1.2)
B/Yamagata	1.9 (1.7 to 2.1)	1.7 (1.5 to 2.0)	1.0 (0.9 to 1.1)

Group i vs Group ii: p = 0.793, Regression, Linear
Group i vs Group ii: p = 0.326, Regression, Linear
Group i vs Group ii: p = 0.933, Regression, Linear

Adverse events

Time frame: Up to approximately 8 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group i: Concomitant	0 of 223 (0%)	0 of 0	0 of 223
Group ii: Influenza Visit 1	0 of 111 (0%)	0 of 0	0 of 111
Group Iii: mRNA COVID-19 Visit 1	0 of 113 (0%)	0 of 0	0 of 113

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 18 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 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With HAI Seroconversion (time frame: Visit 1 (day 1; baseline) to Visit 2 (days 28-42; post-vaccination) for all arms/groups). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06020118.

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 Jun 2025.