Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00307541
Status:
COMPLETED
Last Update Posted:
2020-01-02
First Post:
2006-03-07
Brief Title:
Assess the Immunogenicity of GSK Biologicals 10-valent Pneumococcal Conjugate Vaccine
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Phase IIIa Randomized Controlled Study to Assess the Immunogenicity of GlaxoSmithKline GSK Biologicals 10-valent Pneumococcal Conjugate Vaccine When Administered as a 3-dose Primary Immunization Course Before 6 Months of Age
Status:
COMPLETED
Status Verified Date:
2019-12
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 the immune response of GSK Biologicals 10-valent pneumococcal conjugate vaccine one month after completion of a 3-dose primary vaccination course administered at 2 3 4 months of age
Detailed Description:
Test groups 2 groups 60 subjectsgroup 10Pn-PD-DiT group receiving GSK Biologicals 10-valent pneumococcal conjugate vaccine DTPa-HBV-IPVHib Control group receiving Prevenar DTPa-HBV-IPVHib
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 |
|---|---|---|---|
| 2005-003299-40 | EUDRACT_NUMBER | None | None |