What is the influenza virus split vaccine studying for people aged 60 and above?

This clinical trial is studying the safety and immune response of an influenza virus split vaccine in adults aged 60 years and older. Researchers aim to evaluate how well the vaccine triggers an immune response and monitor any side effects. The Shanghai Institute Of Biological Products is leading this research to better understand influenza vaccination in this age group.

Who may be eligible for this influenza clinical trial?

Adults aged 60 years and older of any gender who can understand the study and participate in follow-up visits may be eligible. Participants should not have had influenza recently or received an influenza vaccine in the past year. People with certain allergies or serious illnesses may be excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this influenza clinical trial?

Study-related care, including the vaccine and all trial visits, is provided at no cost. Personal travel and other expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any costs related to attending study visits.

Actively Recruiting

Phase 1

Age: 60Years +

All Genders

Healthy Volunteers

ID07302256

Phase I Randomized, Double-Blind Study Testing Safety and Immune Response of Influenza Virus Split Vaccine in Adults 60 Years and Older

Led by Shanghai Institute Of Biological Products · Updated on 2026-01-14

120

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and immune response of an influenza virus split vaccine in adults aged 60 years and older through a randomized, double-blind, controlled phase I clinical trial. The study includes 120 participants divided into three groups to compare an experimental vaccine dose, a control vaccine dose, and a placebo. This research aims to understand how well the vaccine works and its side effects in this age group. Participants receive one injection of either the experimental influenza vaccine 0.7 mL, a control vaccine 0.5 mL, or a placebo, each administered into the upper arm muscle. Forty individuals are randomly assigned to each group in equal proportions. Laboratory tests are performed before vaccination and on the fourth day after vaccination to monitor immune response and safety. During the study, participants are closely monitored for any side effects for up to 30 days, including both expected and unexpected adverse events. Serious side effects are tracked for six months after vaccination. Researchers measure immune responses 30 days post-vaccination by checking antibody levels and rates of immune reaction. The study involves follow-up visits to assess safety and vaccine effectiveness, with participation lasting several months.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 60Years +

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Age over 60 years old, any gender, able to provide legal identification
Willing to voluntarily participate and sign an informed consent form
Able to understand the study procedures, use thermometers and scales, complete diary cards, and attend all follow-up visits

You will not qualify if you...

Axillary temperature of 37.3°C or higher on enrollment day
Influenza or influenza-like illness in the past 6 months
Received any influenza vaccine within the past 12 months or plans to receive one during the study
Allergies to vaccine components, gentamicin sulfate, history of severe allergies, or asthma
Serious illness preventing study completion or acute illness in 3 days before vaccination
Use of antipyretic, analgesic, or anti-allergic drugs within 3 days before vaccination
Received any vaccine within 2 weeks before vaccination
Immunosuppressive or immunomodulatory therapy within 6 months before vaccination or planned within 1 month after vaccination, except local medications
Congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, or autoimmune diseases
Serious chronic diseases or uncontrolled cardiovascular, diabetic, liver, kidney, pulmonary, or malignant conditions
Blood or blood product transfusion within past 6 months
Progressive neurological disorders or related psychiatric/family history
Abnormal coagulation or use of anticoagulants within 3 weeks before vaccination
History of splenectomy or important organ resection
Plans to move or leave local area during study visits
Current or planned participation in other clinical trials
Abnormal laboratory test results before vaccination
Any other condition deemed unsuitable by researchers

Research Team

Yang Liu

Chaorong Xu

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