Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00370396
Status:
COMPLETED
Last Update Posted:
2019-06-10
First Post:
2006-08-30
Brief Title:
Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals 10-valent Pneumococcal Conjugate Vaccine
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
To Assess the Safety Reactogenicity Immunogenicity of a 4th Dose of GSK Biologicals Pneumococcal Vaccine or Prevenar in Children 12-18 Months Previously Vaccinated in the Primary Study NCT00307554 With Either Pneumococcal Vaccine or Prevenar
Status:
COMPLETED
Status Verified Date:
2019-06
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 the safety reactogenicity and immunogenicity of a booster dose of GSK Biologicals pneumococcal conjugate vaccine compared to Prevenar given at 12-18 mo of age to children primed with either pneumococcal vaccine or Prevenar in study 105553 Antibody persistence will be evaluated at 8-14 mo after completion of the 3-dose immunization course in study 105553 NCT00307554 The immune response to a booster dose of GSK Biologicals pneumococcal conjugate vaccine will also be evaluated when given at 12-18 mo to subjects not primed with GSK Biologicals vaccine but with Prevenar
The study has 3 groups 1 group of children primed with GSK Biologicals pneumococcal conjugate vaccine will receive a booster dose of the same vaccine 2nd group of children primed with Prevenar will receive a booster dose of Prevenar control group 3rd group of children primed with Prevenar will receive a booster dose of GSK Biologicals pneumococcal conjugate vaccine All children will receive concomitantly a booster dose of DTPa-HBV-IPVHib vaccine
The study has 3 groups 1 group of children primed with GSK Biologicals pneumococcal conjugate vaccine will receive a booster dose of the same vaccine 2nd group of children primed with Prevenar will receive a booster dose of Prevenar control group 3rd group of children primed with Prevenar will receive a booster dose of GSK Biologicals pneumococcal conjugate vaccine All children will receive concomitantly a booster dose of DTPa-HBV-IPVHib vaccine
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006-001628-38 | EUDRACT_NUMBER | None | None |