Actively Recruiting
A Clinical Trial of 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
36 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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
- Volunteers willing to participate and sign informed consent
- Ability to understand study procedures, use thermometers and scales, fill out 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 flu-like illness within the past 6 months
- Receipt of any influenza vaccine within the past 12 months or plans to receive one during the study
- Allergies to vaccine components, gentamicin sulfate, any vaccine/drug, or history of asthma
- Serious illness preventing study completion or acute illness/exacerbation within 3 days before vaccination
- Use of antipyretic, analgesic, or anti-allergic drugs within 3 days before vaccination
- Vaccination with any other vaccine within 2 weeks before vaccination
- Immunosuppressive or immunomodulatory therapy within 6 months before vaccination or planned within 1 month after vaccination, except local medication
- Congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, or autoimmune diseases
- Serious chronic diseases, uncontrolled hypertension or diabetes, liver/kidney diseases, pulmonary edema, malignant tumors
- Blood or blood product transfusion within 6 months
- Progressive neurological disorders or related family history
- Abnormal coagulation or use of anticoagulants within 3 weeks before vaccination
- History of splenectomy or important organ resection
- Plans to move or be away during the study period
- 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
Trial Site Locations
Total: 1 location
1
Danjiangkou Disease Prevention and Control Center
Wuhan, Hubei, China
Actively Recruiting
Research Team
Y
Yang Liu
CONTACT
C
Chaorong Xu
CONTACT
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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