Prevention of influenza caused by vaccine-associated influenza viruses
Conditions
Interventions
Experimental vaccine group:Subjects in the 9 years and older group received 1 full dose
Subjects in the 3-8 years old test group with no prior history of influenza vaccination received 2 full doses (days 0 and 28), and subjects with prior history of influenza vaccination received 1 full
Subjects 6-35 months of age received 2 doses (0 and 28 days).
Control vaccine group 1:Subjects in the 9 years and older group received 1 full dose
Subjects aged 3-8 years with a history of previous influenza vaccination received one full dose
Control vaccine group 2:Subjects 6-35 months of age received 2 doses (0 and 28 days).
Sponsors
Yunnan Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
0.5 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. the age of 6 months; 2. the subject or the subject's legal guardian voluntarily agrees to participate in the trial (=18 years old subject: the subject himself/herself voluntarily agrees to participate in the trial and signs the informed consent form; 8-17 years old subject: the subject himself/herself and his/her legal guardian voluntarily agrees to participate in the trial and his/her legal guardian/delegate signs the informed consent form, and the subject himself/herself signs the informed consent form of a minor; 6 months old - 7 years old (For subjects, the subject's legal guardian voluntarily agrees to the child's participation in the trial, and the informed consent form is signed by the subject's legal guardian/delegate); 3.the subject or the subject's legal guardian is capable of understanding the trial procedures and is able to attend all scheduled follow-up visits; 4.axillary temperature <= 37.0°C on the day of enrollment.
Exclusion criteria
Exclusion criteria: 1. subjects 6-35 months of age who have received any influenza vaccine prior to enrollment (from birth to the day of enrollment) or who are scheduled to receive another influenza vaccine during the trial; 2. subjects 6-35 months of age had a febrile illness within 7 days prior to vaccination, or were using antipyretic and analgesic medications and/or anti-allergic and/or antiviral medications within 7 days prior to vaccination; 3. 6-35 months old and 3-8 years old subjects: those with abnormal growth and development, and those with severe eczema; 4. subjects enrolled at =3 years of age with a febrile illness within 3 days prior to vaccination, or use of antipyretic and analgesic medications and/or anti-allergic and/or antiviral medications within 3 days prior to vaccination; 10. subjects >= 18 years of age with medically uncontrollable hypertension (abnormal blood pressure: systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg on physical examination prior to (on the day of) the first experimental vaccination); 11. Influenza disease (confirmed by any of the clinical, serologic or microbiologic methods) within the previous 6 months; 12. any known or suspected allergy to any component of influenza vaccine; or previous history of severe allergic reaction to any vaccine or drug (including anaphylaxis, anaphylactoid laryngeal edema, anaphylactoid purpura, localized anaphylactic necrotic reaction, etc.); 13. suffering from an acute illness or in the acute exacerbation phase of a chronic disease; 14. epilepsy, history of convulsions or seizures, or a family history of hereditary psychosis 15. autoimmune disease or immunodeficiency, or chronic use of immunosuppressants or other immunomodulatory drugs (defined as use for more than 14 consecutive days), such as systemic use of glucocorticoids (inhaled and topical steroids are not restricted), within 3 months prior to e
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Any local and systemic adverse event (AE)/incidence of adverse reactions;Incidence of serious adverse events and serious adverse reactions;Incidence of abnormal laboratory test indicators; | — |
Secondary
| Measure | Time frame |
|---|---|
| GMT, positive conversion rate (SCR), seroprotection rate (SPR) and GMT growth multiplier (GMI) of HI antibodies by type; | — |
Countries
China
Contacts
Public ContactLiu Xiaoqiang
Yunnan Center for Disease Control and Prevention
Outcome results
None listed