Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00390910
Status:
COMPLETED
Last Update Posted:
2018-12-17
First Post:
2006-10-20
Brief Title:
Study to Evaluate the Safety and Immunogenicity of a 10-valent Pneumococcal Conjugate Vaccine in Preterm Infants
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Study to Assess the Safety and Immunogenicity of GSK Biologicals 10-valent Pneumococcal Conjugate Vaccine When Co-administered With DTPa-HBV-IPVHib Infanrix-Hexa Vaccine in Preterm Infants as a 3-dose Primary Immunization Course During the First 6 Months of Life
Status:
COMPLETED
Status Verified Date:
2017-05
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 aims to evaluate the safety reactogenicity and immunogenicity of GlaxoSmithKline GSK Biologicals 10-valent pneumococcal conjugate vaccine when co-administered with diphtheria tetanus acellular pertussis-hepatitis B virus-inactivated polio virusHaemophilus influenzae type b DTPa-HBV-IPVHib vaccine in preterm infants as a 3-dose primary immunization course during the first 6 months of life
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 00609492
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 00609492
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