Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00356369
Status:
COMPLETED
Last Update Posted:
2018-07-03
First Post:
2006-07-25
Brief Title:
Study in AdolescentsAdults to Evaluate Non-inferiorityPersistence up to 5 Years of GSK Bio MenACWY Conjugate Vaccine
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Phase IIb Primary Vaccination Study to Evaluate Non-Inferiority Persistence of the Immune Response of GSK Biologicals MenACWY Conjugate Vaccine Intramuscularly vs Mencevax ACWY Subcutaneously to Healthy Subjects 11-55 Years of Age
Status:
COMPLETED
Status Verified Date:
2018-05
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:
Meningococcal disease is mostly caused by N meningitidis of serogroups A B C W-135 Y Meningococcal polysaccharide-conjugate vaccines have the advantage to induce a T-cell dependant immune response while the existing polysaccharide vaccines induce a T-cell independent response ie with no immune memory response GSK Biologicals has developed a combined Men ACWY conjugate vaccine intended to protect against meningococcal disease due to serogroups A C W-135 and Y In the vaccination phase of this study the new MenACWY-TT conjugate vaccine will be evaluated in adolescents and adults using Mencevax ACWY as control In the long-term follow-up phase extension phase of the study the long-term protection offered by the new MenACWY-TT conjugate vaccine will be assessed up to five years after the vaccination in adolescents and adults using Mencevax ACWY as control This protocol posting deals with objectives outcome measures of both the primary extension phases
Detailed Description:
All subjects will have 7 blood samples taken prior to and one month after vaccination and one two three four and five years after vaccination No new subjects will be enrolled in the extension phases of this Phase IIb study
The Protocol Posting has been updated in order to comply with the FDA Amendment Act September 2007
The Protocol Posting has been updated in order to comply with the FDA Amendment Act September 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 107406 Ext Y5 | OTHER | GSK | None |
| 107392 Ext Y1 | OTHER | None | None |
| 107398 Ext Y2 | OTHER | None | None |
| 107402 Ext Y3 | OTHER | None | None |
| 107404 Ext Y4 | OTHER | None | None |