Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT00344318
Status:
COMPLETED
Last Update Posted:
2018-12-07
First Post:
2006-06-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
To Assess the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Pneumococcal Conjugate Vaccine Compared to Prevenar™, Co-administered With DTPw-HBV/Hib & 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-HBV/Hib 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-HBV/Hib 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-HBV/Hib 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:
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?: