Trial NCT04352608
Publication Zhang Y, MedRxiv, 2020
Dates: 4/29/2020 to 5/5/2020
Funding: Mixed
(Sponsor: Sinovac Biotech Co., Ltd) (Sinovac Biotech Co., National Key Research and Development Program, Beijing Science and Technology Program )
Conflict of interest: Yes
| Methods | |
| RCT | |
| Location :
* / China Follow-up duration (days): 43 | |
| Inclusion criteria | healthy adults aged 18-59 years |
| Exclusion criteria | The main exclusion criteria included high-risk epidemiological history, positive IgG, IgM or nucleic acid test of pharyngeal or anal swab, axillary temperature >37.0, allergy to a vaccine component, and other unsuitable conditions. |
| Interventions | |
| Treatment 1 Corona Vac 3μg-D0/14 | |
| Control Adjuvant | |
| Treatment 3 Corona Vac 6μg-D0/14 | |
| Treatment 4 Corona Vac 3μg-D0/28 | |
| Treatment 5 Corona Vac 6μg-D0/28 | |
| Participants | |
| Randomized 300 participants n1=120/ n2=60/ n3=120/ n4=120/ n5=120/ | |
| Characteristics of participants Type of participants: Healthy volunteers N=300 Adults: 300 Children: 0 Pregnant women: 0 HIV patients: 0 Health care workers: 0 Participants close contacts to COVID-19 patients: 0 Mean age : 42.5 127 males | |
| Description of participants Healthy volunteers aged 18-59, negative in COVID-19 serum antibodies and SARS CoV-2 infection-free, in a single centre in China. | |
| Primary outcome | |
| In the register 1. Safety indexes of adverse reactions 2.Immunogenicity indexes of neutralizing-antibody seroconversion rates for the emergency vaccination schedule 3.Immunogenicity indexes of neutralizing-antibody seroconversion rates for the routine vaccination schedule. | |
| In the report Not reported | |
| Documents avalaible |
Protocol NR Statistical plan NR Data-sharing stated Yes |
| Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
Some concerns |
| General comment | * |