Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-29 @ 7:36 PM
Study NCT ID:
NCT02093260
Status:
COMPLETED
Last Update Posted:
2015-04-29
First Post:
2014-03-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunogenocity and Safety of Flubio (Influenza HA) Vaccine in Infants and Children (Bridging Study)
Sponsor:
PT Bio Farma
Organization:
Study Overview
Official Title:
Phase II b Study of Immunogenicity and Safety of Flubio Vaccine in Infants and Children
Status:
COMPLETED
Status Verified Date:
2015-04
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 Asses the Immunogenicity and Safety of Flubio (Influenza HA) Vaccine in Infants and Children (Bridging Study)
Detailed Description:
Too see percentage of subjects with HI titer \>= 1:40, 28 days after two doses in infants and children (6 months-8 years old) and one dose in children 9-11 years old for each strain.
Study Oversight
Has Oversight DMC:
False
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?: