Safety and Immunogenicity Study of Inactivated Vaccine for Prophylaxis of SARS CoV-2 Infection (COVID-19)

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

744

Participants

Timeline

Start Date

April 16, 2020

Primary Completion Date

July 10, 2020

Study Completion Date

July 24, 2021

Conditions
COVID-19
Interventions
BIOLOGICAL

Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule

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.

BIOLOGICAL

Two doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule

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.

BIOLOGICAL

Two doses of placebo at the emergency vaccination schedule

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.

BIOLOGICAL

Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule

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.

BIOLOGICAL

Two doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule

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

BIOLOGICAL

Two doses of placebo at the routine vaccination schedule

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.

BIOLOGICAL

Three doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule

Three doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,14,42

BIOLOGICAL

Three doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule

Three doses of high dosage (1200 SU/0.5ml) experimental vaccine at the schedule of day 0,14,42

BIOLOGICAL

Three doses of placebo at the emergency vaccination schedule

Three doses of placebo at the schedule of day 0,14,42

BIOLOGICAL

Three doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule

Three doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,28,56

BIOLOGICAL

Three doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule

Three doses of high dosage (1200 SU/0.5ml) experimental vaccine at the schedule of day 0,28,56

BIOLOGICAL

Three doses of placebo at the routine vaccination schedule

Three doses of placebo at the schedule of day 0,28,56

Trial Locations (1)

221200

Suining County Center for Disease Control and Prevention, Xuzhou

All Listed Sponsors
lead

Sinovac Research and Development Co., Ltd.

INDUSTRY

NCT04352608 - Safety and Immunogenicity Study of Inactivated Vaccine for Prophylaxis of SARS CoV-2 Infection (COVID-19) | Biotech Hunter | Biotech Hunter