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Clinical Trial of Quadrivalent Subunit Influenza Vaccine (Adjuvant) in Chinese Population Aged 65 Years and Older | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1

Clinical Trial of Quadrivalent Subunit Influenza Vaccine (Adjuvant) in Chinese Population Aged 65 Years and Older

A Randomized, Blinded, Controlled Phase I Clinical Trial to Evaluate the Safety of a Quadrivalent Subunit Influenza Vaccine (Adjuvant) in Adults Aged 65 Years and Older

NCT07421037•Ab&B Bio-tech Co., Ltd.JS

View on ClinicalTrials.gov

Summary

The objective of this study was to evaluate the safety of quadrivalent subunit influenza vaccine (adjuvant) in people aged 65 years and older.

Eligibility

Age

65 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Age at enrollment is ≥65 years (including the 65th birthday).
•The participant voluntarily agrees to take part in the trial and has signed the informed consent form.
•The participant is able to comply with the trial follow-up schedule as required by the protocol (i.e., no plans for long-term absence or relocation from the study site).
•Medically stable: The participant may have underlying chronic conditions such as hypertension, diabetes, ischemic heart disease, or hypothyroidism, but symptoms/signs must be controlled. If the participant is on any medication, the dosage must have remained stable for at least three weeks prior to vaccination.

Exclusion Criteria

•Axillary temperature \>37.0°C.
•Confirmed influenza virus infection by laboratory test or self-test kit positive within the past 12 months.
•Received any influenza vaccine (licensed or investigational) within the past 12 months or plans to receive any influenza vaccine during the study.
•Known or suspected allergic to any component of the investigational vaccine.
•A history of severe allergic reactions to any vaccines or medications (for example, but not limited to: anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrotic reaction (Arthus reaction)).
•Congenital malformations or developmental disorders, and genetic defects or severe malnutrition.
•History of convulsions or seizures, epilepsy, psychiatric disorders, or relevant family history.
•Severe liver and kidney diseases, malignant tumors, various acute diseases, or being in the acute exacerbation stage of a chronic disease.
•Diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, or other immune-mediated/autoimmune diseases.
•A history of asthma, unstable within the past two years requiring emergency treatment, hospitalization, intubation, or oral/intravenous corticosteroids.
+11 more criteria

Locations (1)

Yunxi County Center for Disease Control and Prevention

Shiyan, Hubei, China

Key Dates

Start Date

November 13, 2025

Primary Completion Date

December 13, 2026

Completion Date

December 13, 2026

Last Updated

February 19, 2026

Enrollment

ACTUAL participants

Conditions

InfluenzaInfluenza Vaccine

Interventions

Quadrivalent Subunit Influenza Vaccine (Adjuvant)

BIOLOGICAL

Quadrivalent Subunit Influenza Vaccine (Adjuvant)

BIOLOGICAL

MF59

BIOLOGICAL

0.9% sodium chloride injection (normal saline)

BIOLOGICAL

Phase 1/2 Study of a Plant-Based Seasonal Recombinant Trivalent VLP Influenza Vaccine

NCT07291635

Influenza

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RECRUITINGPHASE3

A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts

NCT06094010

Influenza

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RECRUITINGNA

Dime La VerDAD: Verify, Debunk, and Disseminate

NCT06417762

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 19, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Clinical Trial of Quadrivalent Subunit Influenza Vaccine (Adjuvant) in Chinese Population Aged 65 Years and Older

Inclusion Criteria

Exclusion Criteria

Phase 1/2 Study of a Plant-Based Seasonal Recombinant Trivalent VLP Influenza Vaccine

A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts

Dime La VerDAD: Verify, Debunk, and Disseminate

Clinical Outcomes and Pharmacotherapy Effectiveness in the VA Health Care System (COPE-VA)

Effectiveness and Implementation of a National Guideline for Acute Respiratory Tract Infections to Reduce Antibiotic Prescribing in Swiss Primary Care

Administration of the Nasal Influenza Vaccine to Children in Daycare or at a Healthcare Facility