Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00338351
Status:
COMPLETED
Last Update Posted:
2016-09-28
First Post:
2006-06-16
Brief Title:
Safety and Immunogenicity Study of GlaxoSmithKline GSK Biologicals 10-valent Pneumococcal Conjugate Vaccine
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
To Assess Reactogenicity and Immunogenicity of GSK Biologicals 10-valent Pneumococcal Conjugate Vaccine When Co-administered With GSK Biologicals DTPa-HBV-IPVHib Vaccine Infanrix Hexa at 2 4 and 6 Months of Age
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:
Three dose primary vaccination study of reactogenicity and immunogenicity in healthy infants between 6-12 weeks of age at the time of the first vaccination against Streptococcus pneumoniae
Detailed Description:
Test groups 2 120 subjectsgroup 1 group receiving GSK Biologicals 10-valent pneumococcal conjugate vaccine DTPa combined vaccine Control group receiving GSK Biologicals Havrix DTPa combined vaccine
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