Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00196950
Status:
COMPLETED
Last Update Posted:
2016-09-07
First Post:
2005-09-13
Brief Title:
Study to Evaluate Meningococcal Serogroups ACW-135Y Conjugate Vaccine When Given as 1 Dose to Healthy Subjects Aged 18-25 Years
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Assess the Safety Reactogenicity Immunogenicity Long-term Persistence of One Intramuscular Dose of GSK Biologicals MenACWY Conjugate Vaccine vs One Subcutaneous Dose of Mencevax ACWY in Healthy Adults Aged 18-25 Yrs
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:
The purpose of this study is to evaluate the safety reactogenicity immunogenicity and persistence up to three years after administration of one dose of the MenACWY conjugate vaccine when given to young adults aged 18-25 years
Detailed Description:
Administration of the candidate vaccine or of the active control Mencevax ACWY will be done in an open manner The study consists of a vaccination phase during which subjects receive one vaccine dose GSKs MenACWY conjugate vaccine or Mencevax ACWY vaccine and 3 years of follow-up There are in total 7 visits to the doctor before and 2 7 and 30 days after vaccination vaccination phase as well as 12 24 and 36 months after vaccination follow-up phase 7 blood samples are taken one at each visit
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 |
|---|---|---|---|
| 102254 | OTHER | GSK | None |
| 102252 | OTHER | None | None |
| 102253 | OTHER | None | None |