Actively Recruiting
A Randomized, Double-blind, Controlled Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of the Influenza Virus Split Vaccine for Individuals Aged 60 Years and Above
Led by Shanghai Institute Of Biological Products · Updated on 2026-01-14
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive one dose of the influenza virus split vaccine or placebo.
1 vaccination visit (in-person)
Duration - 6 months
Participants are monitored for adverse events and immune response after vaccination.
Visits at 7 days, 30 days, and up to 6 months after vaccination
Trial Site Locations
Total: 1 location
1
Danjiangkou Disease Prevention and Control Center
Wuhan, Hubei, China
Actively Recruiting
Research Team
Y
Yang Liu
C
Chaorong Xu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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