Preliminary Study on Safety and Immunogenicity of Influenza A (H7N9) Vaccine in the Population
Influenza A
About this trial
This is an interventional health services research trial for Influenza A focused on measuring safety investigation
Eligibility Criteria
Inclusion Criteria:
- Permanent healthy residents with normal intelligence meet the minimum age requirement. Literate and willing to provide written informed consent.
- A signed informed consent.
- Willing to comply with the rules of the clinical trial scheme. Accept the blood examination before and after immunization and cooperate follow-up visit.
Exclusion Criteria:
- Exclusion criteria of the first vaccination A person with a history of H7N9 virus infection or suspected infection; Who is allergic to any component of trial vaccine (and past history of any allergy vaccination), especially allergic to eggs; No spleen, or the spleen isn't working; Autoimmune diseases or immunodeficiency, have been treated with immunosuppressant over the past six months; Acute attack of acute illness or chronic disease in almost 7 days; Accept blood products in three months before getting inoculated testing vaccine; Got inoculated active virus vaccine in 14 days or subtype or inactivated virus in 7 days before getting inoculated testing vaccine; Who had been infected by any acute diseases ;
- Who had fever in past 3 days (axillary temperature ≥ 38 ℃);
- Who is participating another clinical trial
- Who had allergies, convulsions, epilepsy, encephalopathy, psychosis history or family history;
- Who is suffering from thrombocytopenia or other coagulation disorder, which may result to intramuscular injection contraindication; The laboratory detection indexes are abnormal before getting inoculated testing vaccine; The females are in suckling period, pregnancy, plan of pregnant or pregnancy tests (positive).
- Who had fever in the past 3 days (axillary temperature ≥ 37.1 ℃). Any other situations investigator think about may affect trial evaluation. Exclusion criteria of the second vaccination Level 3 and above allergic reactions (local and general side effect, vital signs and abnormal laboratory index) related to vaccine were appeared after the first vaccination.
Level 2 and above allergic reactions related to vaccine were appeared after the first vaccination.
-Any other situations investigator think about may affect trial evaluation.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Placebo Comparator
Placebo Comparator
Placebo Comparator
Placebo Comparator
H7N9 split influenza vaccine (15μg/dose)
H7N9 split influenza vaccine (30μg/dose)
H7N9 whole virus influenza vaccine (7.5μg/dose)
H7N9 whole virus influenza vaccine (15μg/dose)
This group was divided into three subgroups according ages of subjects, the ages of those subjects are: 3 to 11(36 subjects got inoculated test vaccines, 18 subjects got inoculated reference vaccines),12 to 17(36 subjects got inoculated test vaccines, 12 subjects got inoculated reference vaccines),≥18 (36 subjects got inoculated test vaccines, 12 subjects got inoculated reference vaccines). Immune procedure: 0,21st day; Physical examination: 0,4th, 21st,25th day; Antibody detection: 0,21st,42nd day.
This group was divided into three subgroups according ages of subjects, the ages of those subjects are: 3 to 11(36 subjects got inoculated test vaccines, 18 subjects got inoculated reference vaccines),12 to 17(36 subjects got inoculated test vaccines, 12 subjects got inoculated reference vaccines),≥18 (36 subjects got inoculated test vaccines, 12 subjects got inoculated reference vaccines). Immune procedure: 0,21st day; Physical examination: 0,4th, 21st,25th day; Antibody detection: 0,21st,42nd day.
This group was divided into two subgroups according ages of subjects, the ages of those subjects are: 12 to 17(54 subjects got inoculated test vaccines,18 subjects got inoculated reference vaccines),≥18 (54 subjects got inoculated test vaccines, 18 subjects got inoculated reference vaccines). Immune procedure: 0,21st day; Physical examination: 0,4th, 21st,25th day; Antibody detection: 0,21st,42nd day.
This group was divided into two subgroups according ages of subjects, the ages of those subjects are: 12 to 17(54 subjects got inoculated test vaccines,18 subjects got inoculated reference vaccines),≥18 (54 subjects got inoculated test vaccines, 18 subjects got inoculated reference vaccines). Immune procedure: 0,21st day; Physical examination: 0,4th, 21st,25th day; Antibody detection: 0,21st,42nd day.