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Large-Scale flu vaccine safety study targets rare side effects

NCT ID NCT07710586

Vaccine Sponsor: Ab&B Bio-tech Co., Ltd.JS 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Last updated Jul 21, 2026 · Updated 2 times

Summary

This study evaluates the safety of a quadrivalent subunit influenza vaccine in over 3,000 healthy individuals aged 3 years and older in Jiangsu Province, China. Researchers track rare adverse reactions, including cerebral infarction, and monitor side effects within 30 minutes, 7 days, and 28 days after vaccination, as well as serious events up to 6 months. The goal is to confirm the vaccine's safety profile in a real-world setting.

What this could mean

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

Active substance
a quadrivalent subunit influenza vaccine
What this could lead to
If successful, this study could confirm the safety profile of this flu vaccine in a large population, supporting its continued use.
What could go wrong
This is a post-marketing safety study, not a test of efficacy. It may detect rare side effects but cannot prove the vaccine prevents flu.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

3,105 people

The number who actually took part.

Started

Nov 2024

Finished

May 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

3 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 1. Healthy individuals aged 3 years or above. 2. The participant (and/or their guardian/legal representative) has provided informed consent, voluntarily agreed to participate, signed the Informed Consent Form, and is able to comply with the requirements of this study protocol. Exclusion Criteria 1. Individuals with a known allergy to any component of the vaccine, including eggs, excipients, formaldehyde, or Triton N-101. 2. Individuals suffering from an acute illness, severe chronic disease, an acute exacerbation of a chronic disease, common cold, or fever. 3. Individuals with uncontrolled epilepsy or other progressive neurological disorders, or a history of Guillain-Barré syndrome. 4. Any other condition considered by the investigator as inappropriate for participation in this study.

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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 vaccine

Contacts and locations

Locations

  • Dongtai Center for Disease Control and Prevention

    Dongtai, Jiangsu, 224200, China

  • Lianshui County Center for Disease Control and Prevention

    Lianshui, Jiangsu, 223400, China

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