A Clinical Trial of Influenza Virus Split Vaccine for Individuals Aged 60 Years and Above

NCT07302256 | Recruiting Phase 1 DMC

• 1 other identifier: SIBP-V05-001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, blinded, controlled phase I clinical trial with a total of 120 participants aged ≥ 60 years. Experimental group: Influenza virus split vaccine (0.7mL/vial), control group 1: Influenza virus split vaccine, control group 2: placebo group. The three groups were recruited at a ratio of 1:1:1, and 40 individuals were randomly vaccinated in each group. Each person was injected with one dose of the vaccine into the deltoid muscle of the upper arm. Participants in each study group are required to undergo laboratory indicator tests before and on the 4th day after vaccination.

Conditions

Influenza

Keywords

Influenza virus split vaccine; The elderly; Immunogenicity; Safety

Outcome Measures

Primary Outcomes (3)

• Unsolicited Adverse Events

  Other adverse events that occurred among participants within 0-30 days after vaccination, in addition to the solicited adverse events.

  30 days after vaccination

• Solicited Adverse Events (AEs)

  Adverse events defined by the protocol that occurred to the participant during 0-7 days after vaccination.

  7 days after vaccination

• Serious Adverse Events (SAE)

  That is serious adverse events, any serious adverse events that occurred to the participant during the study period.

  6 months after vaccination

Secondary Outcomes (4)

• Seroconversion rate

  30 days after vaccination

• Ratio of ≥1:40

  30 days after vaccination

• Geometric mean titer (GMT)

  30 days after vaccination

• Geometric mean increase (GMI)

  30 days after vaccination

Study Arms (3)

Experimental group

EXPERIMENTAL

Influenza virus split vaccine, with a specification of 0.7mL/bottle

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

Control group 1

ACTIVE COMPARATOR

Influenza virus split vaccine, with a specification of 0.5mL/bottle

Biological: Influenza virus split vaccine

Control group 2

PLACEBO COMPARATOR

Phosphate buffer solution

Biological: Phosphate buffer solution (PBS)

Interventions

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

Experimental group

Influenza virus split vaccine BIOLOGICAL

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

Control group 1

Phosphate buffer solution (PBS) BIOLOGICAL

PBS, with a specification of 0.5mL/bottle.

Control group 2

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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;

Sponsors & Collaborators

• Shanghai Institute Of Biological Products: lead

Study Sites (1)

Danjiangkou Disease Prevention and Control Center

Wuhan, Hubei, China

RECRUITING

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Yeqing Tong

  Hubei Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Liu

CONTACT

86-010-65777702; liuyang30@sinopharm.com

Chaorong Xu

CONTACT

86-021-62800991; xuchaorong@sinopharm.com

Study Design

• Study Type: interventional
• Phase: phase 1
• 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 11, 2025
• First Posted: December 24, 2025
• Study Start: December 16, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: January 14, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)