Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00345358
Status:
COMPLETED
Last Update Posted:
2019-01-15
First Post:
2006-06-27
Brief Title:
Immunogenicity and Safety Study of GlaxoSmithKline GSK Biologicals 10-valent Pneumococcal Conjugate Vaccine
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Evaluate Immunogenicity Safety Reactogenicity of GSK Biologicals 10-valent Pneumococcal Conjugate Vaccine Given as Catch-up Immunization in Children Older Than 7 mo of Age or as 3-dose Primary Immunization in Children Before 6 mo of Age
Status:
COMPLETED
Status Verified Date:
2018-07
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:
The purpose of this phase IIIb study is to determine whether children who have not received a 3-dose primary vaccination with the pneumococcal conjugate vaccine before their 6 months of age can receive the vaccine as part of a catch-up immunization schedule The immunogenicity safety and reactogenicity of GSK Biologicals pneumococcal conjugate vaccine will be evaluated for four different age groups with different schedules
6 months of age group 3-dose primary vaccination a booster dose 7 to 11 months of age group 2-dose primary vaccination a booster dose 12 to 23 months of age group 2-dose vaccination no booster dose 24 months to 5 years of age group 1-dose vaccination no booster dose Children below 6 months of age will receive concomitantly a DTPa-IPVHib vaccine
6 months of age group 3-dose primary vaccination a booster dose 7 to 11 months of age group 2-dose primary vaccination a booster dose 12 to 23 months of age group 2-dose vaccination no booster dose 24 months to 5 years of age group 1-dose vaccination no booster dose Children below 6 months of age will receive concomitantly a DTPa-IPVHib vaccine
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