Massive flu vaccine safety check finds no major red flags
NCT ID NCT07332689
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
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42,881 people
The number who actually took part.
- Started
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Oct 2023
- Finished
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Apr 2025
- Lead sponsor
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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
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3 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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
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Gansu Provincial Center for Disease Control and Prevention
Lanzhou, Gansu, 730000, China
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Guangdong Provincial Institute of Biological Products and Materia Medica
Guangzhou, Guangdong, 510440, China
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Hubei Provincial Center for Disease Control and Prevention
Wuhan, Hubei, 430079, China
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Jiangsu Provincial Academy of Preventive Medicine
Nanjing, Jiangsu, 210009, China
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Qinghai Provincial Center for Disease Control and Prevention
Xining, Qinghai, 810007, China
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Shandong Center for Disease Control and Prevention
Jinan, Shandong, 250014, China
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Shanghai Municipal Center for Disease Control and Prevention
Shanghai, Shanghai Municipality, 200336, China
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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.
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