Safety and Immunogenicity Study of Inactivated Vaccine for Prophylaxis of SARS CoV-2 Infection (COVID-19)
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is a randomized, double-blinded, and placebo controlled phase Ⅰ/Ⅱ clinical trial
      of the SARS-CoV-2 inactivated vaccine manufactured by Sinovac Research & Development Co.,
      Ltd. The purpose of this study is to evaluate the safety and immunogenicity of the
      experimental vaccine in healthy adults aged 18~59 Years.
    

Detailed description: 
      This study is a randomized, double-blinded, single-center, placebo-controlled phase Ⅰ/Ⅱ
      clinical trial in adults aged 18~59 years. The purpose of this study is to evaluate the
      immunogenicity and safety of the experimental SARS-CoV-2 inactivated vaccine. The
      experimental vaccine and placebo were both manufactured by Sinovac Research & Development
      Co., Ltd. A total of 744 subjects will be enrolled, with 144 at phase Ⅰ, and 600 at phase Ⅱ.
      All of participants in phase Ⅰ will be assigned to receive two doses of experimental vaccine
      or placebo on the schedule of day 0,14 or day 0,28.300 participants in phase Ⅱ will be
      assigned to receive two doses of experimental vaccine or placebo on the schedule of day 0,14
      or day 0,28 and one dose of booster immunization will be given 6 months after primary
      immunization of day 0,14 or day 0,28.The other 300 participants in phase Ⅱ will be assigned
      to receive three doses of experimental vaccine or placebo on the schedule of day 0,14,42 or
      0,28,56 .
    

Intervention name(s): Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule; Two doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule; Two doses of placebo at the emergency vaccination schedule; Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule; Two doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule; Two doses of placebo at the routine vaccination schedule; Three doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule; Three doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule; Three doses of placebo at the emergency vaccination schedule; Three doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule; Three doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule; Three doses of placebo at the routine vaccination schedule
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Two doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,14,and one dose of booster immunization with medium dosage (600SU/0.5ml) experimental vaccine 6 months after the schedule of day 0,14 in phaseⅡ.; Two doses of high dosage (1200 SU/0.5ml) experimental vaccine at the schedule of day 0,14 and one dose of booster immunization with high dosage (1200SU/0.5ml) experimental vaccine 6 months after the schedule of day 0,14 in phaseⅡ.; Two doses of placebo at the schedule of day 0,14 and one dose of booster immunization with placebo 6 months after the schedule of day 0,14 in phaseⅡ.; Two doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,28 and one dose of booster immunization with medium dosage (600SU/0.5ml) experimental vaccine 6 months after the schedule of day 0,28 in phaseⅡ.; Two doses of high dosage (1200 SU/0.5ml) experimental vaccine at the schedule of day 0,28 and one dose of booster immunization with high dosage (1200SU/0.5ml) experimental vaccine 6 months after the schedule of day 0,28 in phaseⅡ; Two doses of placebo at the schedule of day 0,28 and one dose of booster immunization with placebo 6 months after the schedule of day 0,28 in phaseⅡ.; Three doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,14,42; Three doses of high dosage (1200 SU/0.5ml) experimental vaccine at the schedule of day 0,14,42; Three doses of placebo at the schedule of day 0,14,42; Three doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,28,56; Three doses of high dosage (1200 SU/0.5ml) experimental vaccine at the schedule of day 0,28,56; Three doses of placebo at the schedule of day 0,28,56
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention