Influenza
Conditions
Keywords
Influenza virus split vaccine, The elderly, Immunogenicity, Safety
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.
Interventions
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
BIOLOGICALInfluenza virus split vaccine
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
BIOLOGICALPhosphate buffer solution (PBS)
PBS, with a specification of 0.5mL/bottle.
Sponsors
Shanghai Institute Of Biological Products
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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; * Currently or recently planning to participate in other clinical trials; * Abnormal laboratory test indicators before vaccination; * Researchers determine any situation that is not suitable for clinical trials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unsolicited Adverse Events | 30 days after vaccination | Other adverse events that occurred among participants within 0-30 days after vaccination, in addition to the solicited adverse events. |
| Solicited Adverse Events (AEs) | 7 days after vaccination | Adverse events defined by the protocol that occurred to the participant during 0-7 days after vaccination. |
| Serious Adverse Events (SAE) | 6 months after vaccination | That is serious adverse events, any serious adverse events that occurred to the participant during the study period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Seroconversion rate | 30 days after vaccination | 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. |
| Geometric mean increase (GMI) | 30 days after vaccination | 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. |
| Ratio of ≥1:40 | 30 days after vaccination | 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. |
| Geometric mean titer (GMT) | 30 days after vaccination | 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. |
Countries
China
Contacts
Primary ContactYang Liu
Backup ContactChaorong Xu
Outcome results
None listed