Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 10:56 PM
Study NCT ID:
NCT04718467
Status:
WITHDRAWN
Last Update Posted:
2021-05-25
First Post:
2021-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase IIb Clinical Trial of Recombinant Novel Coronavirus Pneumonia (COVID-19) Vaccine (Sf9 Cells)
Sponsor:
Jiangsu Province Centers for Disease Control and Prevention
Organization:
Study Overview
Official Title:
A Single-center, Randomized, Double-Blinded, Placebo-Controlled, Phase Ⅱb Clinical Trial of Recombinant COVID-19 Vaccine (Sf9 Cells), in the Subjects From Healthy Aged 18 to 85 Years Old
Status:
WITHDRAWN
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decided to cancel this trial.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase Ⅱb, single-center, randomized, double-blind, placebo-controlled study, to evaluate the immunogenicity and safety of the recombinant COVID-19 vaccine (Sf9 cells) in the subjects from healthy adults and elderly adults aged 18 years and above (aged 18-59 and 60-85 years) with immunization procedures 0, 21, 42 days and doses 40μg.
Detailed Description:
This is a phase Ⅱb, single-center, randomized, double-blind, placebo-controlled study, to evaluate the immunogenicity and safety of the recombinant COVID-19 vaccine (Sf9 cells) in the subjects from healthy adults and elderly adults aged 18 years and above (aged 18-59 and 60-85 years) . The phase Ⅱb clinical trials designed two research group, including adults group (aged 18-59 years) and elderly adults group (aged 60-85 years). Each group including 2000 participants. Vaccination or placebo group will be randomly assigned to receive in a 3:1 ratio, 4000 in total.
Study Oversight
Has Oversight DMC:
True
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?: