Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00344318
Status:
COMPLETED
Last Update Posted:
2018-12-07
First Post:
2006-06-23
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 the Safety Reactogenicity and Immunogenicity of GSK Biologicals Pneumococcal Conjugate Vaccine Compared to Prevenar Co-administered With DTPw-HBVHib OPV or IPV Vaccines as a 3-dose Primary Immunization Course During the First 6 Months of Age
Status:
COMPLETED
Status Verified Date:
2018-05
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:
This study will evaluate safety reactogenicity and immunogenicity of GSK Biologicals pneumococcal conjugate vaccine compared to Prevenar when co-administered with DTPw-HBVHib and OPV or IPV vaccines according to 2 different schedules 6-10-14 weeks or 2-4-6 months of age
The study has 2 groups
One group of subjects will receive a 3-dose primary vaccination with the GSK Biologicals pneumococcal conjugate vaccine three different lots will be used and randomly allocated
The 2nd group of subjects will receive a 3-dose primary vaccination with Prevenar
All children will receive concomitantly DTPw-HBVHib and OPV or IPV vaccines This protocol posting deals with objectives outcome measures of the primary study The objectives outcome measures of the Booster study are presented in a separate protocol posting NCT number 00547248
The study has 2 groups
One group of subjects will receive a 3-dose primary vaccination with the GSK Biologicals pneumococcal conjugate vaccine three different lots will be used and randomly allocated
The 2nd group of subjects will receive a 3-dose primary vaccination with Prevenar
All children will receive concomitantly DTPw-HBVHib and OPV or IPV vaccines This protocol posting deals with objectives outcome measures of the primary study The objectives outcome measures of the Booster study are presented in a separate protocol posting NCT number 00547248
Detailed Description:
The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
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