Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00370227
Status:
COMPLETED
Last Update Posted:
2016-10-28
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 Safety Reactogenicity Immunogenicity of a Booster Dose of Pneumococcal Conjugate Vaccine Co-admin With GSK Biologicals MMRV Vaccine in Children 2nd yr of Life Primed With the Pneumococcal Conjugate Vaccine in Study 105553
Status:
COMPLETED
Status Verified Date:
2016-10
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 the pneumococcal conjugate vaccine co-admin with a 1st dose or a 2nd dose of MMRV vaccine at 12-14 or respectively 14-16 months of age in children primed with the pneumococcal conjugate vaccine in study 105553 Antibody persistence will be evaluated at 8-10 months after completion of the 3-dose immunization course in study 105553 The immunogenicity safety and reactogenicity of the 1st and 2nd dose of MMRV vaccine will also be evaluated when co-admin with the pneumococcal conjugate vaccine between 12-16 months of age
The study has 3 groups
The 1st group will receive the booster dose of pneumococcal conjugate vaccine 1st dose of MMRV vaccine at 12-14 mo of age and the booster dose of Infanrix hexa 2nd dose of MMRV vaccine at 14-16 mo of age
The 2nd group will receive the booster dose of Infanrix hexa 1st dose of MMRV vaccine at 12-14 mo of age and the booster dose of pneumococcal conjugate vaccine 2nd dose of MMRV vaccine at 14-16 mo of age
The 3rd group will receive the booster dose of pneumococcal conjugate vaccine the booster dose of Infanrix hexa at 12-14 mo Subjects will be offered one dose of Priorix and Varilrix at 14-16 mo of age outside the study
The study has 3 groups
The 1st group will receive the booster dose of pneumococcal conjugate vaccine 1st dose of MMRV vaccine at 12-14 mo of age and the booster dose of Infanrix hexa 2nd dose of MMRV vaccine at 14-16 mo of age
The 2nd group will receive the booster dose of Infanrix hexa 1st dose of MMRV vaccine at 12-14 mo of age and the booster dose of pneumococcal conjugate vaccine 2nd dose of MMRV vaccine at 14-16 mo of age
The 3rd group will receive the booster dose of pneumococcal conjugate vaccine the booster dose of Infanrix hexa at 12-14 mo Subjects will be offered one dose of Priorix and Varilrix at 14-16 mo of age outside the study
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