Ignite Creation Date:
2024-05-06 @ 3:55 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04801888
Status:
COMPLETED
Last Update Posted:
2021-07-26
First Post:
2021-03-15
Brief Title:
Study on Combined Vaccination With SARS-CoV-2 Inactivated Vaccine and Quadrivalent Influenza Vaccine
Sponsor:
Sinovac Research and Development Co Ltd
Organization:
Sinovac Biotech Co Ltd
Study Overview
Official Title:
A Study to Evaluate the Safety and Immunogenicity of Concomitant Administration of the SARS-CoV-2 Inactivated Vaccine Vero Cell With Quadrivalent Influenza Vaccine in Adults Aged From 18 to 59 Years
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is an open-label single-center randomized phase IV 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 concomitant administration of the SARS-CoV-2 Inactivated Vaccine Vero cell with Quadrivalent Influenza Vaccine in adults aged from 18 to 59 Years
Detailed Description:
This study is an open-label single-center randomized phase IV clinical trial of the SARS-CoV-2 inactivated vaccine Vero cell manufactured by Sinovac Research Development Co Ltd The purpose of this study is to evaluate the safety and immunogenicity of concomitant administration of the SARS-CoV-2 Inactivated Vaccine Vero cell with Quadrivalent Influenza Vaccine in adults aged from 18 to 59 Years 480 healthy adults as participants are randomly assigned into two groups in the ratio 11 The first group was the combined immunization group which is randomly divided into two subgroups 120 subjects in each group The combined immunization subgroup Ⅰ receive SARS-CoV-2 inactivated vaccine Quadrivalent Influenza Vaccine on day 0 and SARS-CoV-2 inactivated vaccine second dose on day 28The combined immunization subgroup Ⅱ receive SARS-CoV-2 inactivated vaccine on day 0 and SARS-CoV-2 inactivated vaccine second dose Quadrivalent Influenza Vaccine on day 28 The second group was the non combined immunization groupwhich receive SARS-CoV-2 inactivated vaccine first dose on day 0 Quadrivalent Influenza Vaccine on day 14 and SARS-CoV-2 inactivated vaccine second dose on day 28
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None