NCT07327398

Brief Summary

To evaluate the immunogenicity of administering one dose of influenza virus split vaccine (0.7mL/dose) to individuals aged 60 and above.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for phase_2

Timeline
5mo left

Started Jan 2026

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress45%
Jan 2026Sep 2026

First Submitted

Initial submission to the registry

December 25, 2025

Completed
13 days until next milestone

Study Start

First participant enrolled

January 7, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 8, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

January 15, 2026

Status Verified

December 1, 2025

Enrollment Period

9 months

First QC Date

December 25, 2025

Last Update Submit

January 13, 2026

Conditions

Influenza

Keywords

Influenza virus split vaccineSafetyImmunogenicityThe elderly

Outcome Measures

Primary Outcomes (4)

  • Seroconversion rate

    30 days after vaccination of all participants with the experimental vaccine or control vaccines, the HI antibody seroconversion rate against any subtype of influenza virus in the experimental vaccine group or the control vaccine groups.

    30 days after vaccination

  • Ratio of ≥1:40

    30 days after vaccination of all participants with the experimental vaccine or control vaccines, the ratio of HI antibody titers ≥ 1:40 against any subtype of influenza virus in the experimental vaccine group or the control vaccine groups.

    30 days after vaccination

  • Geometric mean titer (GMT)

    30 days after vaccination of all participants with the experimental vaccine or control vaccines, GMT of HI antibodies against any subtype of influenza virus in the experimental vaccine group or the control vaccine groups.

    30 days after vaccination

  • Geometric mean increase (GMI)

    30 days after vaccination of all participants with the experimental vaccine or control vaccines, GMI of HI antibodies against any subtype of influenza virus in the experimental vaccine group or the control vaccine groups.

    30 days after vaccination

Secondary Outcomes (3)

  • Solicited Adverse Events (AEs)

    7 days after vaccination

  • Unsolicited Adverse Events

    30 days after vaccination

  • Serious Adverse Events (SAEs)

    6 months after vaccination

Study Arms (2)

Influenza virus split vaccine (0.7mL/vial)

EXPERIMENTAL

Influenza virus split vaccine (0.7mL/vial)

Biological: Influenza virus split vaccine (0.7mL/vial)

Influenza virus split vaccine

ACTIVE COMPARATOR

Influenza virus split vaccine

Biological: Influenza virus split vaccine

Interventions

Influenza virus split vaccineBIOLOGICAL

Influenza virus split vaccine, with a specification of 0.5mL/bottle, containing 15 μ g of hemagglutinin from H1N1, H3N2, and B influenza virus strains each.

Influenza virus split vaccine
Influenza virus split vaccine (0.7mL/vial)BIOLOGICAL

Influenza virus split vaccine, with a specification of 0.7mL/bottle, containing 60 μ g of hemagglutinin from H1N1, H3N2, and B influenza virus strains each Control: Influenza virus split vaccine.

Influenza virus split vaccine (0.7mL/vial)

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age over 60 years old, gender not limited, and able to provide legal identification;
  • Volunteers voluntarily participate in the study and sign an informed consent form;
  • Volunteers have the ability to understand research procedures, use thermometers, scales, and fill out diary cards as required, and can participate in all planned follow-up visits.

You may not qualify if:

  • On the day of enrollment, the axillary temperature was ≥ 37.3 ℃;
  • Those who have had influenza in the past 6 months or meet the definition of influenza like cases;
  • Have received any influenza vaccine within the past 12 months or have planned to receive any influenza vaccine during the study period;
  • Allergies to any components of the research vaccine, history of allergic reactions to the use of gentamicin sulfate, history of severe allergies to any vaccine/drug, or history of asthma;
  • Suffering from a serious illness that prevents the completion of the entire study; Within 3 days prior to vaccination, there is an acute illness or an acute exacerbation of a chronic disease;
  • Have used antipyretic or analgesic drugs or anti allergic drugs within 3 days before vaccination;
  • Have received any vaccine within 2 weeks prior to vaccination;
  • Have received immunosuppressive therapy or other immunomodulatory drugs within 6 months prior to receiving the experimental vaccine, For example, immunosuppressive doses of glucocorticoids, monoclonal antibodies, thymosin, interferon, etc., or planned to receive such treatment within one month after the first dose of vaccination to full immunization, but local medication is allowed;
  • Suffering from congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, or other autoimmune diseases;
  • Suffering from serious chronic diseases, serious cardiovascular diseases, such as hypertension that cannot be controlled by drugs, diabetes that cannot be controlled by drugs or has serious complications, liver and kidney diseases, pulmonary edema, malignant tumors, etc;
  • Have received blood or blood related products within the past 6 months;
  • Individuals with progressive neurological disorders, including a history of seizures, epilepsy, encephalopathy, Guillain Barr é syndrome, psychiatric or family history;
  • Have a history of abnormal coagulation function and have been using anticoagulants within 3 weeks before vaccination;
  • Patients with splenectomy, functional splenectomy, splenectomy, or other important organ resection or partial resection;
  • Plan to move before the end of the study or leave the local area for a long time during the scheduled study visit;
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Danjiangkou City Center for Disease Control and Prevention

Wuhan, Hubei, China

Location

Yunxi County Center for Disease Control and Prevention

Wuhan, Hubei, China

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Central Study Contacts

Yang Liu

CONTACT

86-010-65777702liuyang30@sinopharm.com

Chaorong Xu

CONTACT

86-021-62800991xuchaorong@sinopharm.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 25, 2025

First Posted

January 8, 2026

Study Start

January 7, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

January 15, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)