influenza
Conditions
Interventions
Phase I cohort 1 low-dose group(aged 18~49):inject one dose of the low-dose experimental vaccine
Phase I cohort 1 low-dose placebo group(aged 18~49):inject one dose of the low-dose placebo
Phase I cohort 2 high-dose group(aged 18~49):inject one dose of the high-dose experimental vaccine
Phase I cohort 2 high-dose placebo group(aged 18~49):inject one dose of the high-dose placebo
Phase I cohort 3 low-dose group(aged 50 and above):inject one dose of the low-dose experimental vaccine
Phase I cohort 3 low-dose placebo group(aged 50 and above):inject one dose of the low-dose placebo
Phase I cohort 4 high-dose group(aged 50 and above):inject one dose of the high-dose experimental vaccine
Phase I cohort 4 high-dose placebo group(aged 50 and above):inject one dose of the high-dose placebo
Phase II low-dose group (18-49 years old):inject one dose of the low-dose experimental vaccine
Phase II high-dose group (18-49 years old):inject one dose of the high-dose experimental vaccine
Phase II positive control group(18-49 years old):inject one dose of the positive control vaccine
Phase II low-dose group (aged 50 and above):inject one dose of the low-dose experimental vaccine
Phase II high-dose group (aged 50 and above):inject one dose of the high-dose experimental vaccine
Phase II positive control group(aged 50 and above):inject one dose of the positive control vaccine
Sponsors
Hebei Province Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.When signing the informed consent form, be at least 18 years old and provide valid identification; 2.The subject is able to understand the procedures and methods of this clinical trial, has given sufficient informed consent, voluntarily participated, and signed an informed consent form by the subject themselves; 3.On the day of enrollment, axillary temperature was <= 37.0 ?; 4.Female and male participants of childbearing age: agree to take effective contraceptive measures within 6 months after vaccination.
Exclusion criteria
Exclusion criteria: 1.The laboratory test indicators specified in the protocol are abnormal and clinically significant before vaccination (only for Phase I); 2.Have contracted influenza within the past 6 months prior to enrollment (confirmed by any clinical or microbiological method); 3.Previously or currently suffering from autoimmune or immunodeficiency diseases; 4.Previous history of severe allergies to any vaccine/drug or any component of the experimental vaccine, such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, respiratory distress, angioneurotic edema, or individuals with an allergic constitution (such as allergies to two or more drugs, food, or pollen); History of severe allergy to eggs or egg protein; 5.Have received any influenza vaccine within the 6 months prior to enrollment, or plan to receive influenza vaccine other than the vaccine used in this trial during the trial period (before completing the immunization and collecting blood samples); 6.Within 30 days prior to enrollment, any investigational or unregistered products (drugs, vaccines, or devices) have been used, or are planned to be used during the trial period (except for the vaccine used in this trial) (before completing the immunization and collecting blood samples); 7.The interval between receiving attenuated live vaccines before enrollment is less than 30 days, and the interval between receiving other non live vaccines is less than 14 days; 8.Within the first 3 days of enrollment, have experienced acute illness or are in the acute phase of chronic illness; 9.Used antipyretic, analgesic, or anti allergic drugs within 3 days prior to enrollment; 10.Use immunoglobulin and/or any blood products within 3 months prior to enrollment, or plan to use them during the trial period (before completing immunization and collecting blood samples); 11.Long term use of immunosuppressants or other immunomodulatory drugs (defined as continuous use for more than 14 days) within the first 3 months of enrollment, such as a glucocorticoid dose of = 0.5 mg/kg/day (inhalation and local steroid hormones are not restricted); 12.Absence of spleen, functional absence of spleen, and splenectomy caused by any condition; 13.Any obvious coagulation dysfunction or history of anticoagulant therapy; 14.History of epilepsy, encephalopathy, and malignant tumors; 15.Suffering from serious cardiovascular system diseases, serious hypertension with unstable drugs (systolic pressure >=160mmHg and/or diastolic pressure >= 100mmHg), diabetes with serious complications and other serious chronic diseases; 16.Currently suffering from respiratory system diseases (including pneumonia, tuberculosis, severe asthma, chronic bronchitis, etc.), acute liver and kidney diseases (severe impairment of liver and kidney function), mental disorders (such as schizophrenia, depression, affective disorders, etc.), etc; 17.Women of childbearing age who are breastfeeding, pregnant, or have a positive urine pregnancy test before enrollment; 18.Plan to move out of the local area before the end of the study or plan to leave the local area for a long time during the study visit; 19.According to the researchers' judgment, the subjects have any other factors that are not suitable for participating in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All adverse event occurrences;All adverse event of special interest occurrences;All serious adverse event occurrences;Changes in clinical significance of laboratory test indicators on the 4th day after vaccination compared to before vaccination (applicable only to Phase I);Positive conversion rate of Hemagglutination Inhibition antibodies against 4 types of influenza virus;Serum protection rate of Hemagglutination Inhibition antibodies against 4 types of influenza virus;Neutralizing antibodies Geometric mean titers of Hemagglutination Inhibition antibodies against 4 types of influenza virus;Geometric increase of Hemagglutination Inhibition antibodies against 4 types of influenza virus; | — |
Countries
China
Contacts
Public ContactJin Fei
Hebei Province Center for Disease Control and Prevention
Outcome results
None listed