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Boosted flu shot tested in hospital workers – could it offer better protection?

NCT ID NCT06054269

Vaccine Sponsor: Centers for Disease Control and Prevention Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed Phase 3 trial tested whether an adjuvanted flu vaccine (FLUAD Quadrivalent) triggers a stronger immune response than a standard flu vaccine (FluQuadri) in 192 healthcare workers in Lima, Peru. Participants received one dose of either vaccine, and researchers measured antibody levels at 28 days and 6 months after vaccination. The goal is to see if the adjuvanted version offers better protection against influenza.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
FLUAD Quadrivalent (adjuvanted influenza vaccine)
What this could lead to
If it works, this could show that an adjuvanted flu vaccine provides stronger or longer-lasting protection for healthcare workers than the standard vaccine.
What could go wrong
This is a completed Phase 3 trial with 192 participants, so results are reliable but may not apply to other populations or flu seasons. Adjuvanted vaccines can cause more local side effects like soreness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

192 people

The number who actually took part.

Started

Nov 2022

Finished

May 2026

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * ≥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); * Women of childbearing age must complete the following criteria to be eligible: 1. Have a negative urine pregnancy test performed by the study staff ≤24 hours preceding receipt of the vaccine; 2. 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; 3. Must not be breastfeeding. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

influenza prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Influenza

Contacts and locations

Locations

  • Hospital Nacional Arzobispo Loayza

    Lima, 15082, Peru

  • Hospital Nacional Cayetano Heredia

    Lima, 15102, Peru

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