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Safety and Immunogenicity of Sinovac's COVID-19 Vaccine (CoronaVac) in Healthy Elderly
NCT04383574Phase 2
Key facts
- Status
- Completed
- Start
- May 2020
- Primary completion
- Dec 2021
- Countries
- 1
- Sponsor
- Sinovac Life Sciences
- Modality
- Whole Inactivated Vaccines
- Drugs
- coronavac
- Conditions
- coronavirus disease 2019 (COVID-19)
01
Overview
Phase 2, randomised, double-blind trial of coronavac in coronavirus disease 2019 (COVID-19) (7 arms), sponsored by Sinovac Life Sciences. Primary endpoints: Incidence of adverse reactions and Seroconversion rates of neutralizing antibody. Started May 2020; status: completed.
02
Design
7 arms- Study design
- RandomizedDouble-blind
Phase 1 Medium
Medium dosage (600SU), 2 doses + booster at 1 year
Phase 1 High
High dosage (1200SU), 2 doses + booster at 1 year
Phase 1 Placebo
Placebo, 2 doses + booster at 1 year
Phase 2 Low
Low dosage (300SU), 2 doses + booster at 6 months
Phase 2 Medium
Medium dosage (600SU), 2 doses + booster at 6 months + 2nd booster at 1 year post-dose 2
Phase 2 High
High dosage (1200SU), 2 doses + booster at 6 months + 2nd booster at 1 year post-dose 2
1 more in the full profile.
03
Who it enrols
Healthy elderly adults aged 60 and above with no history of SARS-CoV-2 infection or recent travel to high-risk areas.
04
Endpoints
Primary
Incidence of adverse reactions
Seroconversion rates of neutralizing antibody
Secondary
Incidence rate of adverse reactions within 7 days
Incidence rate of serious adverse events in Phase 1
Incidence rate of serious adverse events in Phase 2
Seropositive rate, GMT, and GMI of neutralizing antibodies
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