Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT05568693
Status:
UNKNOWN
Last Update Posted:
2022-10-06
First Post:
2022-09-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sequential Enhanced Safety Study of a Novel Coronavirus Messenger RNA (mRNA) Vaccine in Adults Aged 18 Years and Older.
Sponsor:
Yu Qin
Organization:
Study Overview
Official Title:
Sequential Enhanced Safety Study of a Novel Coronavirus mRNA Vaccine in Adults Aged 18 Years and Older Who Have Completed 3 Doses of a New Inactivated Coronavirus Vaccine.
Status:
UNKNOWN
Status Verified Date:
2022-10
Last Known Status:
ENROLLING_BY_INVITATION
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 trial is a clinical study to evaluate the safety of sequential boosters of novel coronavirus mRNA vaccine in adults aged 18 years and older who have completed three doses of novel inactivated coronavirus vaccination. According to the results of the previous phase I clinical trial, the incidence of adverse reactions in the 0.3 ml dose group was lower than that in the 0.5 ml dose group, and the degree of adverse reactions was weaker. The dose of 0.3ml was chosen for the current study, and a 1-dose immunization program was completed for safety observation.
Detailed Description:
According to the results of the preliminary phase I clinical trial, the incidence of adverse reactions in subjects in the 0.3 ml dose group was lower than in the 0.5 ml dose group and the degree of adverse reactions was weaker. The dose of 0.3ml was chosen for the current study.
The trial was designed to enroll 800 adult subjects aged 18 years and older who had completed three doses of inactivated New Coronavirus vaccine with an interval of more than 6 months between doses, and the proportion of elderly people aged 60 years and older was approximately 20%. Subjects will receive 0.3 ml of mRNA vaccine, complete a 1-dose immunization program, and undergo safety observations.
The trial was designed to enroll 800 adult subjects aged 18 years and older who had completed three doses of inactivated New Coronavirus vaccine with an interval of more than 6 months between doses, and the proportion of elderly people aged 60 years and older was approximately 20%. Subjects will receive 0.3 ml of mRNA vaccine, complete a 1-dose immunization program, and undergo safety observations.
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?: