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Massive flu vaccine safety check finds no major red flags

NCT ID NCT07332689

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study checked the safety of a quadrivalent flu vaccine in over 42,800 people aged 3 and older. Researchers looked for side effects within 30 minutes, 7 days, and 28 days after vaccination. The goal was to find any very rare adverse reactions. Results help confirm the vaccine's safety for widespread use.

What this could mean

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

Active substance
quadrivalent subunit influenza vaccine
What this could lead to
If successful, this study confirms the vaccine's safety in a large population, supporting its continued use to prevent flu.
What could go wrong
This is a completed safety study, not a test of effectiveness. Rare side effects may still emerge in even larger populations.

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.

Participants

42,881 people

The number who actually took part.

Started

Oct 2023

Finished

Apr 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.

Who is studied

Healthy individuals aged 3 years or above

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.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Gansu Provincial Center for Disease Control and Prevention

    Lanzhou, Gansu, 730000, China

  • Guangdong Provincial Institute of Biological Products and Materia Medica

    Guangzhou, Guangdong, 510440, China

  • Hubei Provincial Center for Disease Control and Prevention

    Wuhan, Hubei, 430079, China

  • Jiangsu Provincial Academy of Preventive Medicine

    Nanjing, Jiangsu, 210009, China

  • Qinghai Provincial Center for Disease Control and Prevention

    Xining, Qinghai, 810007, China

  • Shandong Center for Disease Control and Prevention

    Jinan, Shandong, 250014, China

  • Shanghai Municipal Center for Disease Control and Prevention

    Shanghai, Shanghai Municipality, 200336, China

  • Xinjiang Uygur Autonomous Region Center for Disease Control and Prevention

    Ürümqi, Xinjiang Uygur Autonomous Region, 830002, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.