Preliminary Study on Safety and Immunogenicity of Influenza A (H7N9) Vaccine in the Population
Condition: Influenza A
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      Adopt the design of random, blind method and placebo to parallel control and progressive
      methods of groups to study and evaluate the safety and immunogenicity of influenza A (H7N9)
      vaccine (two types, one type with two specifications) on people of different ages. The
      vaccines used for testing include: influenza A (H7N9) virus inactivated vaccine/split
      influenza vaccine (15μg /dose), influenza A (H7N9) virus inactivated vaccine/split influenza
      vaccine (30μg / dose), influenza A (H7N9) virus inactivated vaccine/whole influenza vaccine
      (7.5μg / dose) and influenza A (H7N9) virus inactivated vaccine/ whole influenza vaccine
      (15μg / dose).

      The study between different subgroups was carried out in an orderly and progressive manner,
      that is, each kind of vaccine by the dose is from low to high according to the order of age
      from old to young. Firstly, the study on 15μg/dose split vaccine group (aged 18 and above)
      and 7.5μg/dose whole-virus vaccine group (aged 18 and above) was carried out and then the
      study on 15μg/dose split vaccine group (aged 12-17) and 7.5μg/dose whole-virus vaccine group
      (aged 12-17) was conducted upon 7-day safety was confirmed after the vaccination, finally the
      study on 30μg/dose split vaccine group (aged 18 and above) and 15μg/dose whole-virus vaccine
      group (aged 18 and above) was done. By that analogy for the same conditions, the next group
      of test can be done after the 7-day safety of the last group of vaccine is confirmed.

      Subjects and researchers didn't know the formulations of the vaccines used. The vaccine is
      injected into the upper arm deltoid muscle. After 30 minutes of field observation on safety,
      the subjects' axillary temperature shall be recorded on the Record Book prepared by the
      research and local and systemic reactions to injection at the 6th, 24th, 48th, and 72th hour
      and on the 4th, 8th, 21st and 30th day shall also be recorded. This paper collected 5 serum
      samples: day 0 (before the first-dose vaccination), day 4 (after the first-dose vaccination),
      day 21 (before the second-dose vaccination), day 25 (fourth day after the second-dose
      vaccination) and day 42 (21st day after the second-dose vaccination), of which, blood samples
      on day 0, 21 and 42 should be stored at 18℃ for antibody detection and the remaining 2 blood
      samples are only used for blood routine examination, routine urine test, blood biochemistry
      and other laboratory examinations.
    


Intervention name(s): Influenza A (H7N9) virus vaccine
Intervention type(s): Biological
Intervention description(s): To prevent the infection of H7N9 virus.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects were inoculated with influenza A (H7N9) virus inactivated vaccine/split influenza vaccine or placebo.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: safety investigation