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Flu vaccine study in kids aims to find best dosing strategy

NCT ID NCT06095947

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a quadrivalent influenza vaccine in 652 healthy children aged 3-8 years. Researchers compared immune responses after one dose versus two doses, and also checked for side effects. The goal was to find the best way to protect children against flu.

What this could mean

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

Active substance
quadrivalent influenza vaccine (split virion, inactivated)
What this could lead to
If successful, this could help determine the best dosing schedule for flu protection in young children.
What could go wrong
This is a completed study focused on immune response and safety, not on preventing actual flu illness. Results may not apply to other age groups or flu seasons.

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

652 people

The number who actually took part.

Started

Sep 2021

Finished

Feb 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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 people aged 3-8 years old

Ages

3 to 8 years

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: * 3-8 years old; * The legal guardian / authorized agent gives the informed consent and voluntarily signs the informed consent to comply with the requirements of the clinical trial protocol; * Medical history, physical examination and clinical diagnosis, who to the immunization of this product. * children who have received two or more doses of influenza vaccine (4 weeks apart) before the season of this influenza epidemic (2 doses of influenza vaccine do not need to be vaccinated in the same epidemic season or consecutive epidemic season, but can be interpreted as children who have received two or more cumulative shots). History of l No immunization: children who had not been vaccinated or had previously received \<2 doses of influenza vaccine before the influenza season. Exclusion Criteria: 1.1.1The exclusion criteria for the first needle To l allergic to any component of the quadrialent influenza vaccine (history of any previous vaccine allergy), especially those allergic to eggs; The l axillary body temperature was 37.5℃ before inoculation; * Any influenza vaccine (registered or research) within 6 months prior to enrollment; or planned for use during the study period; * Use of immunoglobulin and / or any blood products within 3 months prior to enrollment; or planned for use during the study (before blood sampling); * Patients with a history of Guillain-Barre syndrome; l Acute disease, severe chronic disease, acute onset of chronic disease, cold; * Uncontrolled epilepsy; * Has been diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, or other autoimmune diseases; * those receiving immune booster or inhibitor treatment within 3 months (continuous oral or drip for more than 14 days); * History of abnormal coagulation function (such as lack of coagulation factors, coagulation disease); * Primary and secondary impaired immunity (history of thyroid, pancreas, liver and spleen resection); * A history of severe allergic reactions to vaccination; * live attenuated vaccine within 14 days before vaccination and other vaccines within 7 days before vaccination; * Is in or recently planning to participate in other clinical trials; * Other conditions judged by the investigator as not suitable for participation in this clinical trial. 1.1.2 Exclusion criteria for the second needle * Patients with severe allergic reactions after the previous dose of vaccination; * Serious adverse reactions with a causal relationship with the previous dose of vaccination; l For newly detected or those who do not meet the inclusion criteria of the first injection or meet the exclusion criteria of the first injection, the investigator will determine whether to continue to participate in the study; * Other reasons for exclusion as considered by the investigator.

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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

  • Kou Zengqiang

    Jinan, Shandong, 250000, China