Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06342349
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-03-26
Brief Title:
A Clinical Trial of Quadrivalent Influenza Virus Split Vaccine MDCK Cells for Individuals Aged 6 Months and Above
Sponsor:
Shanghai Institute Of Biological Products
Organization:
Shanghai Institute Of Biological Products
Study Overview
Official Title:
A Randomized Double-blind Controlled Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of the Quadrivalent Influenza Virus Split Vaccine MDCK Cells for Individuals Aged 6 Months and Above
Status:
RECRUITING
Status Verified Date:
2024-03
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:
To evaluate the safety of administering 1 or 2 doses of the quadrivalent influenza virus split vaccine MDCK cells 05mldose in individuals aged 6 months and above
Detailed Description:
This is a single center randomized double-blind controlled phase I clinical trial Plan to include 300 participants aged 6 months and above The experiment was divided into 5 age groups with 60 cases each aged 6-35 months 3-8 years 9-17 years 18-59 years and 60 years old Each age group was randomly assigned to the experimental group control group or placebo group in a 111 ratio Among them the participants aged 6 to 35 months and 3 to 8 years old will receive 2 doses throughout the entire process with an interval of 28 days between each dose Participants aged 9-17 18-59 and 60 years old are vaccinated with one dose throughout the entire process
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