Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00169481
Status:
COMPLETED
Last Update Posted:
2017-01-10
First Post:
2005-09-12
Brief Title:
A Study in Children With Different Formulations of GSK Biologicals 11 Valent Pneumococcal Conjugate Vaccine
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Randomized Controlled Phase II Study to Evaluate the Safety and Immunogenicity of Different Formulations of GlaxoSmithKline Biologicals 11-valent Pneumococcal Conjugate Vaccine When Administered Intramuscularly as a 3-dose Primary Immunization 2-3-4 Month Schedule Before 6 Months of Age
Status:
COMPLETED
Status Verified Date:
2017-01
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 with 11-valent pneumococcal conjugate vaccine administered concomitantly with Infanrix hexa to healthy infants between 8 to 16 weeks of age at the time of first vaccination
Detailed Description:
Test groups 9 groups receiving different formulations of 11PN-PD-DiT vaccine DTPa-HBV-IPVHib Infanrix hexa Comparator 11Pn-PD Infanrix hexa Control Prevenar Infanrix hexa
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