Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-02-25 @ 5:52 PM
Study NCT ID:
NCT00338351
Status:
COMPLETED
Last Update Posted:
2016-09-28
First Post:
2006-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine.
Sponsor:
GlaxoSmithKline
Organization:
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-IPV/Hib 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 subjects/group). 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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: