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New flu vaccine for toddlers shows promise in large trial

NCT ID NCT05645900

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This large Phase 3 trial tested a new quadrivalent flu vaccine in over 2,700 healthy children aged 6 to 35 months. The study compared two doses of the experimental vaccine against a standard flu vaccine to see how well it triggers an immune response and whether it is safe. Researchers monitored side effects and collected blood samples to measure antibody levels. The trial is now complete, and results will show if this vaccine is a good option for protecting young children from the 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 virus subunit vaccine
What this could lead to
If successful, this could provide a safe and effective flu vaccine option for young children, helping to reduce flu illness in this age group.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. The vaccine may not prove more effective than existing options, and side effects like fever or injection site reactions are possible.

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

2,772 people

The number who actually took part.

Started

Feb 2023

Finished

Oct 2023

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

6 to 35 months

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: * 6-35 months healthy infants; * The legal guardian voluntarily consented to the subject's participation in the study, and the legal guardian/trustee signed the Informed Consent Form and complied with the requirements of the protocol. Exclusion Criteria: 1. Exclusion criteria for the first dose: * Armpit temperature ≥37.3℃ on the day of enrollment; * Persons infected with influenza virus confirmed by laboratory testing within the previous 6 months; * Received any influenza vaccine (registered or experimental) within the previous 12 months or planned to receive any influenza vaccine during the study period; * Allergic to any components of the vaccine, such as eggs, excipients, formaldehyde, etc; * Previous history of severe allergy to any vaccine or drug (e.g., but not limited to: anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local anaphylactic necrosis reaction (Arthus reaction); * 6-23 months: premature (delivered before the 37th week of gestation), low weight (birth weight \<2500g) , or a history of dystocia, asphyxia rescue, and neurological damage; * Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc; * Acute disease, serious chronic disease or acute attack of chronic disease on the day of vaccination; * Congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), juvenile rheumatoid arthritis (JRA), or other autoimmune diseases; * History of asthma, instability within the past two years requiring emergency treatment, hospitalization, intubation, oral or intravenous corticosteroids; * Progressive neurological disease, history of seizures, epilepsy, encephalopathy, Guillain-Barre syndrome, or history or family history of mental illness; * Suffering from serious cardiovascular disease (heart disease, pulmonary heart disease, pulmonary edema); * Asplenia, functional asplenia, and asplenia or splenectomy resulting from any condition; Resection or partial resection of other important organs; * History of coagulation dysfunction (e.g., coagulation factor deficiency, coagulation disease); * A history of live attenuated vaccine vaccination within 14 days and a history of other vaccines within 7 days before vaccination; * Immune-boosting or suppressant therapy within 3 months (continuous oral or intravenous infusion for more than 14 days); * Received blood or blood-related products; * Plan to relocate prior to the completion of the study or to be away for an extended period during the scheduled study visit; * Being or planning to participate in other clinical trials in the near future; * Any ineligibility to participate in the trial was determined by the investigator. 2. Exclusion criteria for the second dose: * Severe allergic reaction after the first dose of vaccine; * Serious adverse reactions related to the first dose of vaccine; * The investigator will decide whether to continue to participate in the study if new findings or new occurrence after the first dose inoculation do not meet the inclusion criteria of the first dose or the exclusion criteria of the first dose; * Other reasons for exclusion, according to 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

  • Ab&b Biotechnology Co., Ltd.JS

    Taizhou, Jiangsu, 225300, China

More trials for these conditions

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