Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00224471
Status:
COMPLETED
Last Update Posted:
2016-09-21
First Post:
2005-09-21
Brief Title:
Study to Compare Safety and Immunogenicity of Commercial Scale Consistency Lots of Herpes Simplex Vaccine
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Phase III Double-blind Randomized Study to Compare 1 the Immunogenicity and Safety of 3 Commercial Scale Consistency Lots of GlaxoSmithKline GSK Biologicals Herpes Simplex Candidate Vaccine in Healthy HSV-1 and -2 Seronegative HSV 1-2- Female Subjects Aged 10 - 17 Years and 2 Vaccine Immunogenicity in Healthy HSV 1-2- Females Aged 10 - 17 Years With Healthy HSV 1-2- Adult Females
Status:
COMPLETED
Status Verified Date:
2016-09
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:
Evaluate one month after the third dose the lot-to-lot consistency of 3 different commercial scale production lots of the candidate vaccine in healthy HSV 1-2- females aged 10-17 years determined by ELISA Absence in significant variation for both parameters among the tested lots was hypothesized
Detailed Description:
At month 0 1 and 6 3 groups of 184 subjects received each 3 doses of herpes simplex vaccine lot A B or C respectively The study took 14 months to complete including screening and 6 visits were required The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
Study Oversight
Has Oversight DMC:
None
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?:
None