Clinical Trial of Immunogenicity Bridging of a Recombinant New Coronavirus（COVID-19） Vaccine (CHO Cell)
Condition: COVID-19
MeSH terms: COVID-19; Coronavirus Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      Popular topic: A clinical trial comparing the immunogenicity of recombinant New Coronavirus
      vaccine (CHO cells) among people aged 3 to 17 and 18 to 59 years of age.

      Overall design:Non inferiority test design was used to evaluate the immunogenicity of the
      vaccine inoculated to the age group of 3~17 and the age of 18~59. The non inferiority
      hypothesis test was conducted with the results of immunogenicity of the 18-59 year old group
      in China in the phase III clinical trial of recombinant New Coronavirus vaccine (CHO cell).

      Study population:400 healthy people aged 3 to 17 years old, both male and female.
    

Detailed description: 
      Study population:A total of 400 healthy people aged 3 ~ 17 were enrolled (including 130 cases
      aged 3 ~ 5, 150 cases aged 6 ~ 11, and 120 cases aged 12 ~ 17)，both male and female.

      Overall design:Non inferiority test design was used to evaluate the immunogenicity of the
      vaccine inoculated to the age group of 3~17 and the age of 18~59. The non inferiority
      hypothesis test was conducted with the results of immunogenicity of the 18-59 year old group
      in China in the phase III clinical trial of recombinant New Coronavirus vaccine (CHO cell).

      Immunization program: Three doses were inoculated in 0, 1 and 2 months. Dose:25μg/0.5mL/dose.

      Safety endpoint:

        1. AE and SAE:Collect all adverse events (AES) 30 minutes after each dose of vaccination,
           all AES 0-7 days (including solicited and non solicited AES), all AES 8-30 days (non
           solicited AES), and all SAE from the first dose of vaccination to 12 months after the
           whole course of immunization.

        2. Vital signs and physical examination:

           All subjects underwent axillary temperature examination every day during the screening
           period, before the next dose of vaccination and within 7 days after each dose of
           vaccination.

           All subjects underwent physical examination (skin and cardiopulmonary auscultation)
           during the screening period.

        3. Pregnancy events:

           For women of childbearing age, urine pregnancy test should be carried out before each
           dose of vaccination.

           The pregnancy events occurred within 12 months from the first dose of vaccine to the
           whole course of immunization were collected.

        4. ADE / VED risk monitoring:

      After vaccination (at least one dose of test vaccine) (at each visit), remind the subjects to
      contact the investigator in time for fever and / or respiratory symptoms (such as dyspnea,
      sore throat, etc.) and covid-19 suspected or confirmed cases during the study. If the subject
      is suspected or confirmed to be infected with sars-cov-2 during the test, he must go to the
      local Xinguan designated hospital for hospitalization diagnosis and treatment. Detailed case
      investigation shall be conducted for confirmed cases. In case of severe or dead cases of new
      crown infection, an expert meeting shall be held to conduct special investigation and
      evaluate whether it is ADE/ VED.
    

Intervention name(s): Recombinant new coronavirus vaccine (CHO cell)
Intervention type(s): Biological
Intervention description(s): Intramuscular injection of deltoid muscle of upper arm of 25μg/0.5ml/person /dose Recombinant new coronavirus vaccine (CHO cells).
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Recombinant Novel Coronavirus Vaccine