Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00454987
Status:
COMPLETED
Last Update Posted:
2020-06-16
First Post:
2007-03-30
Brief Title:
Study of Long-term Antibody Persistence After a Booster Dose of Menitorix Vaccine
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Assessment of Long-term Antibody Persistence After a Booster Dose of GSK Biologicals Hib Meningococcal C Vaccine Menitorix 811936 Given at 12-15 Months of Age to Subjects Primed With 3 Doses of Menitorix at 2 3 4 Months of Age
Status:
COMPLETED
Status Verified Date:
2020-06
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:
The purpose of this study is to evaluate the long-term antibody persistence at 12 24 and 48 months after the administration of a booster dose of Menitorix given at 12-15 months of age The children had previously received 3 doses of Menitorix and Infanrix IPV or Meningitec and Pediacel in infancy In addition the antibody persistence is to be investigated in children of 40-43 months of age who received a 3-dose primary vaccination of a MenC conjugate vaccine and a Hib containing vaccine in infancy without a booster dose of MenC conjugate and Hib vaccine in the second year of life
This protocol posting deals with objectives outcome measures of the extension phases at 12 24 and 48 months after the booster phase The links to objectives and outcome measures of the primary phase booster phase at 12 to 15 months are provided below
httpswwwgsk-studyregistercomstudy2747 Primary phase httpswwwgsk-studyregistercomstudy2755 Booster phase
This protocol posting deals with objectives outcome measures of the extension phases at 12 24 and 48 months after the booster phase The links to objectives and outcome measures of the primary phase booster phase at 12 to 15 months are provided below
httpswwwgsk-studyregistercomstudy2747 Primary phase httpswwwgsk-studyregistercomstudy2755 Booster phase
Detailed Description:
This multicentre multicountry study is open and has 2 study groups at Visits 1 and 3 HibMenC and LicMenC An additional control group in the UK at the time of the second year follow-up for persistence subjects aged 40-43 months primed with MenC conjugate and Hib vaccines in infancy with no subsequent booster dose group NoBoost at Visit 2 These subjects will receive a Hib catch-up vaccine at 40-43 months of age The subjects of groups HibMenC and LicMenC were randomized in the primary vaccination study 103974 and will not be further randomized The subjects of group NoBoost will not be randomized All subjects at the UK centre will receive Infanrix-IPV at the second visit ie 24 months after Menitorix booster or at 40-43 months of age In addition the subjects of group NoBoost will receive a Hib catch-up vaccine Menitorix at the same visit
Subjects of groups HibMenC and LicMenC will have 3 blood samples taken for immunogenicity analyses at 12 24 48 months after the booster vaccination Subjects of group NoBoost will have 1 blood sample taken for immunogenicity analyses at 40-43 months of age 75 new subjects will be enrolled in this study group NoBoost
Subjects of groups HibMenC and LicMenC will have 3 blood samples taken for immunogenicity analyses at 12 24 48 months after the booster vaccination Subjects of group NoBoost will have 1 blood sample taken for immunogenicity analyses at 40-43 months of age 75 new subjects will be enrolled in this study group NoBoost
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 |
|---|---|---|---|
| 2006-006460-32 | EUDRACT_NUMBER | GSK | None |
| 109666 | OTHER | None | None |
| 109668 | OTHER | None | None |