Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-29 @ 7:21 AM
Study NCT ID:
NCT00877357
Status:
UNKNOWN
Last Update Posted:
2009-05-06
First Post:
2009-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Long Term Immunogenicity and Lot Consistency Study of Liquid Pentavalent Combination Vaccine
Sponsor:
Shantha Biotechnics Limited
Organization:
Study Overview
Official Title:
Open Label Multicentric Randomized Phase IV Post Marketing Safety, Immunogenicity and Lot-to-Lot Consistency Analysis of Shan 5 [DTPwHB-Hib (Liquid) Pentavalent Combination Vaccine] in Indian Infants
Status:
UNKNOWN
Status Verified Date:
2009-04
Last Known Status:
RECRUITING
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 phase IV study of the liquid pentavalent combination vaccine to evaluate the safety, immunogenicity (short term and long term) and clinical consistency of three production lots of the vaccine.
Detailed Description:
None
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?: