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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

422

Participants

Timeline

Start Date

May 22, 2020

Primary Completion Date

December 28, 2021

Study Completion Date

May 31, 2022

Conditions
COVID-19
Interventions
BIOLOGICAL

Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28

The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research \& Development Co., Ltd..Two doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,28,and one dose of booster immunization(the third dose) with medium dosage (600SU/0.5ml) experimental vaccine 1 year after primary immunization at the schedule of day 0,28 in phaseⅠand 6 months after primary immunization at the schedule of day 0,28 in phase Ⅱ.And the second booster dose (the fourth dose) 1 year after the second dose.

BIOLOGICAL

Two doses of high dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28

The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research \& Development Co., Ltd..Two doses of high dosage (1200SU/0.5ml) experimental vaccine at the schedule of day 0,28,and one dose of booster immunization(the third dose) with medium dosage (1200SU/0.5ml) experimental vaccine 1 year after primary immunization at the schedule of day 0,28 in phaseⅠand 6 months after primary immunization at the schedule of day 0,28 in phase Ⅱ.And the second booster dose (the fourth dose) 1 year after the second dose.

BIOLOGICAL

Two doses of placebo at the schedule of day 0,28

The placebo was manufactured by Sinovac Research \& Development Co., Ltd., Two doses of placebo at the schedule of day 0,28,and one dose of booster immunization with placebo 1 year after primary immunization at the schedule of day 0,28 in phaseⅠand 6 months after primary immunization at the schedule of day 0,28 in phase Ⅱ.

BIOLOGICAL

Two doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28

The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research \& Development Co., Ltd..Two doses of low dosage (300SU/0.5ml)experimental vaccine at the schedule of day 0,28,and one dose of booster immunization with low dosage (300SU/0.5ml) experimental vaccine 6 months after primary immunization at the schedule of day 0,28 in phase Ⅱ.

Trial Locations (1)

062550

Renqiu City Center for Disease Control and Prevention, Renqiu

All Listed Sponsors
lead

Sinovac Life Sciences Co., Ltd.

INDUSTRY

NCT04383574 - Safety and Immunogenicity Study of Inactivated Vaccine for Prevention of SARS-CoV-2 Infection(COVID-19) | Biotech Hunter | Biotech Hunter