Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-30 @ 4:38 PM
Study NCT ID:
NCT03893669
Status:
COMPLETED
Last Update Posted:
2019-03-28
First Post:
2012-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability and Immunogenicity of an Trivalent Inactivated Cell-Culture Influenza Vaccine in Healthy Adults
Sponsor:
SK Chemicals Co., Ltd.
Organization:
Study Overview
Official Title:
Randomized, Double-blinded, Controlled, Phase I Trial to Assess Safety, Tolerability and Immunogenicity of 'NBP607(Trivalent Inactivated Cell-Culture Influenza Vaccine)' Compared to Egg-based Influenza Vaccine in Healthy Adult
Status:
COMPLETED
Status Verified Date:
2012-10
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:
A randomized, double-blinded, controlled, Phase I clinical trial to assess the safety, tolerability and immunogenicity of 'NBP607(trivalent inactivated cell-culture influenza vaccine)' compared to egg-based influenza vaccine in healthy adult volunteers
Detailed Description:
1. Assessment of Safety
2. Assessment of Immunogenicity
3. Estimated Enrollment: 100
2. Assessment of Immunogenicity
3. Estimated Enrollment: 100
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: