InfluenzaPhase 3EDUCATENCT06054269

Clinical Trial to Evaluate the Immunogenicity of an Adjuvanted Influenza Vaccine Among HCP

A Phase 3 study testing FLUAD Quadrivalent and FluQuadri in people with Influenza, run by Centers for Disease Control and Prevention at 2 sites in Peru.

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 randomized, double-blinded trial will assess humoral immune responses to adjuvanted, egg-based quadrivalent influenza vaccines compared to standard dose, egg-based quadrivalent influenza vaccines among healthcare personnel (HCP). The trial will be conducted at two sites in Lima, Peru during 2022 and 2023. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: FLUAD Quadrivalent and FluQuadri
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 192 participants
Where: 2 sitesPeru
Study dates: 4 Nov 2022to 4 May 2026
Phase: Phase 3
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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

≥18 years old;
Have participated in the healthcare personnel cohort study at Hospital Nacional Cayetano Heredia or Hospital Nacional Arzobispo Loayza during 2016-2021;
Work at the facility full-time (≥30 hours per week);
Have routine, direct, hands-on or face-to-face contact with patients (≤1 meter) as part of a typical work shift, including, but not limited to, physicians, nurses, respiratory therapists, physical therapists, unit clerks, radiograph technicians, medical assistants, and transporters;
Work at the facility for ≥1 year prior to enrollment and planning to continue working at the facility for one year after enrollment;
Willing to receive influenza vaccination (adjuvanted or standard dose);

Show all 10Show fewer

Women of childbearing age must complete the following criteria to be eligible:
Have a negative urine pregnancy test performed by the study staff ≤24 hours preceding receipt of the vaccine;
Be willing to use a reliable form of contraception approved by the Investigator for ≤2 months after receiving the vaccine. If they are not currently using an approved contraceptive, study staff will provide access to contraceptives;
Must not be breastfeeding.

Who cannot join

Have received a vaccine against influenza during the 2022 influenza season (season of clinical trial);
Have a severe, life-threatening allergy to influenza vaccines, eggs, or influenza vaccine components;
Have a history of Guillain-Barre Syndrome or other autoimmune diseases;
Received blood or blood products within 3 months of enrollment;
Be pregnant, confirmed by rapid pregnancy test.

Trial locations and contacts

2 sites in 1 country.

Peru2 sites

Hospital Nacional Arzobispo Loayza
Lima, 15082
Hospital Nacional Cayetano Heredia
Lima, 15102

Other trials in Peru

About this study

Official title: Randomized Controlled Trial, Double Blind, Phase III, to Evaluate the Immunogenicity of an Adjuvanted Influenza Vaccine Among Health Care Personnel (EDUCATE)

Read the detailed description

The trial will be conducted at two hospital sites in Lima, Peru during 2022-2023 among HCP who were previously enrolled in the Cohort study of Influenza and other Respiratory Viruses among HCP in Peru (cohort size: approximately 1500 participants). The minimum number of participants to be enrolled is 248 in total (142 subjects per vaccine group), and the aim is to enroll approximately 800 participants (400 subjects per vaccine group). The study design is a randomized, double-blind vaccine trial. Eligible HCP at each site who consent to participate will be randomized 1:1 to receive either a single dose of adjuvanted egg-based quadrivalent influenza vaccine (AD, FLUAD Quadrivalent by Seqirus, 15 µg of hemagglutinin [HA] from each strain) or standard dose, egg-based quadrivalent influenza vaccine (SD, FluQuadri by Sanofi-Pasteur, 15 µg of HA from each strain).

Participants will be invited to come to the study site to be screened for eligibility to participate in the clinical trial. After they consent to participate and sign informed consent form, participants will visit the site for medical assessment and vaccination. Additional brief medical adverse event assessments will be performed on days 3 and 7. Participants will be followed up to twice per week via SMS or phone calls to assess if they become sick with a respiratory event. In the event they become sick, they will be asked questions about their illness through an acute illness survey and a mid-turbinate nasal swab specimen will be collected and tested for influenza virus. Additional surveys will be administered on day 28 post-vaccination as well as at the end of the influenza season.

Participants will have blood collected just prior to vaccination (Day 0) and at approximately 28 days and 6 months post-vaccination (or at the end of influenza virus circulation as determined by active surveillance data) to evaluate humoral immune responses to vaccination. After these specimens are tested, differences in seroconversion and seroprotection between AD and SD vaccination groups will be assessed. In addition, we multivariable modelling will be used to assess risk factors for poor immunogenicity and to assess possible effects of repeated vaccination.

As an optional sub-study, indicators of cell-mediated immune (CMI) responses to influenza vaccination will be examined. This part of the study, which is optional to participants, will require collection of additional blood samples at prior to vaccination (Day 0) and at 7 and 28 days post-vaccination.

Conditions: Influenza
Being tested: FLUAD Quadrivalent, FluQuadri
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FLUAD QuadrivalentBiological
0.5 mL intramuscular dose of FLUAD Quadrivalent
FluQuadriBiological
0.5 mL intramuscular dose of FluQuadri

Study groups in NCT06054269
Study group	Role	What they receive
FLUAD Quadrivalent	Experimental	Participants administered a single dose of adjuvanted egg-based quadrivalent influenza vaccine (FLUAD Quadrivalent by Seqirus, 15 µg of HA from each strain). Receives: Biological: FLUAD Quadrivalent
FluQuadri	Active comparator	Participants administered a single dose of standard dose egg-based quadrivalent influenza vaccine (FluQuadri by Sanofi-Pasteur, 15 µg of HA from each strain). Receives: Biological: FluQuadri

What is being measured

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

Hemagglutination Inhibition (HI) Geometric Mean Titers (GMT) Post-vaccination (Day 28) of Each Vaccine Reference Virus
The geometric mean of antibody titers after a single dose of FLUAD Quadrivalent (adjuvanted dose, AD) vs. FluQuadri (standard dose, SD) as measured by HI assay for egg-grown influenza A(H1N1)pdm09, A(H3N2), B/Yamagata, and B/Victoria vaccine reference viruses at approximately 28 days post-vaccination
Measured: 28 days post-vaccination
HI GMT Post-vaccination (6 Months) of Each Vaccine Reference Virus
The geometric mean of antibody titers after a single dose of AD vs SD vaccine as measured by HI assay for egg-grown influenza A(H1N1)pdm09, A(H3N2), B/Yamagata, and B/Victoria vaccine reference viruses at approximately 6 months post-vaccination
Measured: 6 months post-vaccination
Seroconversion Rate (SCR) to Each Vaccine Reference Virus Post-vaccination
The percent of participants with paired samples that achieved ≥4-fold rises comparing post- (approximately 28 days) versus pre-vaccination titers, and post-vaccination titers ≥40 for each vaccine reference virus (egg-grown influenza A(H1N1)pdm09, A(H3N2), B/Yamagata, and B/Victoria vaccine reference viruses) following a single dose of AD vs. SD vaccine.
Measured: 28 days post-vaccination
SCR to Each Vaccine Reference Virus Post-vaccination
The percent of participants with paired samples that achieved ≥4-fold rises comparing post- (approximately 6 months) versus pre-vaccination titers, and post-vaccination titers ≥40 for each vaccine reference virus (egg-grown influenza A(H1N1)pdm09, A(H3N2), B/Yamagata, and B/Victoria vaccine reference viruses) following a single dose of AD vs. SD vaccine.
Measured: 6 months post-vaccination
Seroprotection Rate (SPR) to Each Vaccine Reference Virus Post-vaccination
The percent of participants with post-vaccination titers ≥40 for each vaccine reference virus (egg-grown influenza A(H1N1)pdm09, A(H3N2), B/Yamagata, and B/Victoria vaccine reference viruses) following a single dose of AD vs. SD vaccine.
Measured: 28 days post-vaccination
SPR to Each Vaccine Reference Virus Post-vaccination
The percent of participants with post-vaccination titers ≥40 for each vaccine reference virus (egg-grown influenza A(H1N1)pdm09, A(H3N2), B/Yamagata, and B/Victoria vaccine reference viruses) following a single dose of AD vs. SD vaccine.
Measured: 6 months post-vaccination

Timeline

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

4 Nov 20224 May 2026

First posted26 Sep 2023
Study start4 Nov 2022
Primary completion25 Jul 2023
Study completion4 May 2026

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.
Publications (1)Papers the sponsor has linked to this study.
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: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 192 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06054269
Sponsor's protocol ID: NAMRU6.2019.0011
Acronym: EDUCATE
Status last verified: May 2026
First submitted: 19 Sep 2023
Last updated: 19 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: No current plans to share IPD

Publications

Marcenac P, Soto G, Yau T, Carreon JD, Romero C, Gonzales M, La Rosa S, Arriola CS, Prouty M, Diaz RAH, Romero FA, Llanos-Cuentas A, Prado EDM, Silva M, Fowlkes A, Levine MZ, Azziz-Baumgartner E, Duca LM, Neyra J. Comparison of the immunogenicity of adjuvanted and conventional egg-based quadrivalent influenza vaccines among healthcare personnel in Lima, Peru: A randomized controlled trial. Int J Infect Dis. 2026 Jan;162:108205. doi: 10.1016/j.ijid.2025.108205. Epub 2025 Nov 11.
PubMed 41232749

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 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Controlled Trial, Double Blind, Phase III, to Evaluate the Immunogenicity of an Adjuvanted Influenza Vaccine Among Health Care Personnel (EDUCATE)
ClinicalTrials.gov ID: NCT06054269
Acronym / sponsor ID: EDUCATE / NAMRU6.2019.0011
Conditions: Influenza
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 192 participants (actual)
Lead sponsor: Centers for Disease Control and PreventionUS federal agency
Collaborators: Peruvian Clinical Research, Hospital Nacional Cayetano Heredia, Hospital Nacional Arzobispo Loayza, U.S. Naval Medical Research Unit No.6 (NAMRU-6)
Study start: 4 Nov 2022 (actual)
Primary completion: 25 Jul 2023 (actual)
Study completion: 4 May 2026 (actual)
First posted: 26 Sep 2023 (actual)
Results: Posted 29 May 2025

Clinical summary

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

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
FLUAD Quadrivalent	Experimental	Biological: FLUAD QuadrivalentParticipants administered a single dose of adjuvanted egg-based quadrivalent influenza vaccine (FLUAD Quadrivalent by Seqirus, 15 µg of HA from each strain).
FluQuadri	Active comparator	Biological: FluQuadriParticipants administered a single dose of standard dose egg-based quadrivalent influenza vaccine (FluQuadri by Sanofi-Pasteur, 15 µg of HA from each strain).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

≥18 years old;
Have participated in the healthcare personnel cohort study at Hospital Nacional Cayetano Heredia or Hospital Nacional Arzobispo Loayza during 2016-2021;
Work at the facility full-time (≥30 hours per week);
Have routine, direct, hands-on or face-to-face contact with patients (≤1 meter) as part of a typical work shift, including, but not limited to, physicians, nurses, respiratory therapists, physical therapists, unit clerks, radiograph technicians, medical assistants, and transporters;
Work at the facility for ≥1 year prior to enrollment and planning to continue working at the facility for one year after enrollment;

Key exclusion criteria (5 listed)

Have received a vaccine against influenza during the 2022 influenza season (season of clinical trial);
Have a severe, life-threatening allergy to influenza vaccines, eggs, or influenza vaccine components;
Have a history of Guillain-Barre Syndrome or other autoimmune diseases;
Received blood or blood products within 3 months of enrollment;
Be pregnant, confirmed by rapid pregnancy test.

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
FLUAD Quadrivalent0.5 mL intramuscular dose of FLUAD Quadrivalent	Biological	FLUAD Quadrivalent
FluQuadri0.5 mL intramuscular dose of FluQuadri	Biological	FluQuadri

Primary outcome

Hemagglutination Inhibition (HI) Geometric Mean Titers (GMT) Post-vaccination (Day 28) of Each Vaccine Reference Virus
Time frame: 28 days post-vaccination
The geometric mean of antibody titers after a single dose of FLUAD Quadrivalent (adjuvanted dose, AD) vs. FluQuadri (standard dose, SD) as measured by HI assay for egg-grown influenza A(H1N1)pdm09, A(H3N2), B/Yamagata, and B/Victoria vaccine reference viruses at approximately 28 days post-vaccination
HI GMT Post-vaccination (6 Months) of Each Vaccine Reference Virus
Time frame: 6 months post-vaccination
The geometric mean of antibody titers after a single dose of AD vs SD vaccine as measured by HI assay for egg-grown influenza A(H1N1)pdm09, A(H3N2), B/Yamagata, and B/Victoria vaccine reference viruses at approximately 6 months post-vaccination
Seroconversion Rate (SCR) to Each Vaccine Reference Virus Post-vaccination
Time frame: 28 days post-vaccination
The percent of participants with paired samples that achieved ≥4-fold rises comparing post- (approximately 28 days) versus pre-vaccination titers, and post-vaccination titers ≥40 for each vaccine reference virus (egg-grown influenza A(H1N1)pdm09, A(H3N2), B/Yamagata, and B/Victoria vaccine reference viruses) following a single dose of AD vs. SD vaccine.
SCR to Each Vaccine Reference Virus Post-vaccination
Time frame: 6 months post-vaccination
The percent of participants with paired samples that achieved ≥4-fold rises comparing post- (approximately 6 months) versus pre-vaccination titers, and post-vaccination titers ≥40 for each vaccine reference virus (egg-grown influenza A(H1N1)pdm09, A(H3N2), B/Yamagata, and B/Victoria vaccine reference viruses) following a single dose of AD vs. SD vaccine.
Seroprotection Rate (SPR) to Each Vaccine Reference Virus Post-vaccination
Time frame: 28 days post-vaccination
The percent of participants with post-vaccination titers ≥40 for each vaccine reference virus (egg-grown influenza A(H1N1)pdm09, A(H3N2), B/Yamagata, and B/Victoria vaccine reference viruses) following a single dose of AD vs. SD vaccine.
SPR to Each Vaccine Reference Virus Post-vaccination
Time frame: 6 months post-vaccination
The percent of participants with post-vaccination titers ≥40 for each vaccine reference virus (egg-grown influenza A(H1N1)pdm09, A(H3N2), B/Yamagata, and B/Victoria vaccine reference viruses) following a single dose of AD vs. SD vaccine.

Results and safety

Results posted to the registry on 29 May 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
FLUAD Quadrivalent	95	95
FluQuadri	97	97

Primary outcome: Hemagglutination Inhibition (HI) Geometric Mean Titers (GMT) Post-vaccination (Day 28) of Each Vaccine Reference Virus

Time frame: 28 days post-vaccination. Geometric least squares mean (95% Confidence Interval). Unit: antibody titer

Measure	FLUAD Quadrivalent n = 95	FluQuadri n = 95
Influenza A(H1N1)pdm09	584.2 (453.1 to 753.3)	342.8 (265.9 to 442.0)
Influenza A(H3N2)	217.4 (173.0 to 273.1)	169.0 (134.5 to 212.3)
Influenza B/Victoria	102.1 (76.5 to 136.2)	107.8 (80.8 to 143.9)
Influenza B/Yamagata	211.1 (170.5 to 261.4)	184.4 (148.9 to 228.4)

FLUAD Quadrivalent vs FluQuadri: p = 0.004, Wilcoxon (Mann-Whitney)
FLUAD Quadrivalent vs FluQuadri: p = 0.066, Wilcoxon (Mann-Whitney)
FLUAD Quadrivalent vs FluQuadri: p = 0.694, Wilcoxon (Mann-Whitney)

Primary outcome: HI GMT Post-vaccination (6 Months) of Each Vaccine Reference Virus

Time frame: 6 months post-vaccination. Geometric least squares mean (95% Confidence Interval). Unit: antibody titer

Measure	FLUAD Quadrivalent n = 94	FluQuadri n = 96
Influenza A(H1N1)pdm09	177.4 (137.2 to 229.3)	128.4 (99.6 to 165.5)
Influenza A(H3N2)	94.1 (75.0 to 118.0)	67.2 (53.7 to 84.1)
Influenza B/Victoria	34.5 (25.8 to 46.1)	41.2 (30.9 to 54.9)
Influenza B/Yamagata	55.5 (43.2 to 71.4)	57.0 (44.4 to 73.0)

FLUAD Quadrivalent vs FluQuadri: p = 0.164, Wilcoxon (Mann-Whitney)
FLUAD Quadrivalent vs FluQuadri: p = 0.113, Wilcoxon (Mann-Whitney)
FLUAD Quadrivalent vs FluQuadri: p = 0.404, Wilcoxon (Mann-Whitney)

Primary outcome: Seroconversion Rate (SCR) to Each Vaccine Reference Virus Post-vaccination

Time frame: 28 days post-vaccination. Number (95% Confidence Interval). Unit: percentage of participants

Measure	FLUAD Quadrivalent n = 95	FluQuadri n = 95
Influenza A(H1N1)pdm09	88.4 (80.4 to 93.4)	62.1 (52.1 to 71.2)
Influenza A(H3N2)	82.1 (73.2 to 88.5)	62.1 (52.1 to 71.2)
Influenza B/Victoria	47.4 (37.6 to 57.3)	52.6 (42.7 to 62.4)
Influenza B/Yamagata	63.2 (53.1 to 72.2)	49.5 (39.6 to 59.4)

FLUAD Quadrivalent vs FluQuadri: p <0.001, Chi-squared
FLUAD Quadrivalent vs FluQuadri: p = 0.002, Chi-squared
FLUAD Quadrivalent vs FluQuadri: p = 0.468, Chi-squared

Primary outcome: SCR to Each Vaccine Reference Virus Post-vaccination

Time frame: 6 months post-vaccination. Number (95% Confidence Interval). Unit: percentage of participants

Measure	FLUAD Quadrivalent n = 94	FluQuadri n = 96
Influenza A(H1N1)pdm09	53.2 (43.2 to 63.0)	41.7 (32.3 to 51.7)
Influenza A(H3N2)	50.0 (40.1 to 59.9)	39.6 (30.4 to 49.6)
Influenza B/Victoria	18.1 (11.6 to 27.1)	28.1 (20.1 to 37.8)
Influenza B/Yamagata	16.0 (9.9 to 24.7)	10.4 (5.8 to 18.1)

FLUAD Quadrivalent vs FluQuadri: p = 0.112, Chi-squared
FLUAD Quadrivalent vs FluQuadri: p = 0.149, Chi-squared
FLUAD Quadrivalent vs FluQuadri: p = 0.101, Chi-squared

Adverse events

Time frame: Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FLUAD Quadrivalent	0 of 95 (0%)	70 of 95 (73.7%)	0 of 95
FluQuadri	0 of 97 (0%)	61 of 97 (62.9%)	0 of 97

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41232749Marcenac P, Soto G, Yau T, Carreon JD, Romero C, Gonzales M, La Rosa S, Arriola CS, Prouty M, Diaz RAH, Romero FA, Llanos-Cuentas A, Prado EDM, Silva M, Fowlkes A, Levine MZ, Azziz-Baumgartner E, Duca LM, Neyra J. Comparison of the immunogenicity of adjuvanted and conventional egg-based quadrivalent influenza vaccines among healthcare personnel in Lima, Peru: A randomized controlled trial. Int J Infect Dis. 2026 Jan;162:108205. doi: 10.1016/j.ijid.2025.108205. Epub 2025 Nov 11.
Individual participant dataSharing planned: No. No current plans to share IPD

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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.

Giselle Soto, MD, MPH principal investigator

Naval Medical Research Unit- 6

Roger Antonio Hernandez Diaz, MD, MSc principal investigator

Hospital Nacional Cayetano Heredia

Eduardo Demetrio Matos Prado, MD principal investigator

Hospital Nacional Arzobispo Loayza

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FLUAD Quadrivalent and FluQuadri in people with Influenza, run by Centers for Disease Control and Prevention at 2 sites in Peru.

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 10 inclusion and 5 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 19 May 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 Peru. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 29 May 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?

Hemagglutination Inhibition (HI) Geometric Mean Titers (GMT) Post-vaccination (Day 28) of Each Vaccine Reference Virus (time frame: 28 days post-vaccination). The study lists 6 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 NCT06054269, which also lists 1 linked publication.

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 19 May 2026.