Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00129129
Status:
COMPLETED
Last Update Posted:
2018-08-24
First Post:
2005-08-10
Brief Title:
Comparison of GSKBiologicals Hib-MenCY-TT Vaccine vs Licensed Hib Conjugate or Meningococcal Vaccine
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Evaluate Immuno and Safety of GSKBiologicals HibMenCYTT vs Licensed Hib Conjugate Vaccine Each Coadministered With Pediarix and Prevnar in Healthy Infants An Exploratory Control Group Will Receive Licensed Menomune at 3 to 5 Years
Status:
COMPLETED
Status Verified Date:
2016-09
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 is evaluating the safety and immunogenicity of GSK Biologicals Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine each administered at 2 4 and 6 months of age and compared to licensed meningococcal serogroups A C Y and W-135 polysaccharide vaccine administered at 3 to 5 years of age
The safety and immunogenicity of a booster dose of Hib-MenCY-TT vaccine will be compared to a booster dose of licensed Hib conjugate vaccine each administered at 12 to 15 months of age The group primed with the Hib conjugate vaccine will re-randomized at 12-15 months of age to receive a booster dose of Hib-MenCY-TT or a booster dose of the Hib conjugate vaccine
The safety and immunogenicity of a booster dose of Hib-MenCY-TT vaccine will be compared to a booster dose of licensed Hib conjugate vaccine each administered at 12 to 15 months of age The group primed with the Hib conjugate vaccine will re-randomized at 12-15 months of age to receive a booster dose of Hib-MenCY-TT or a booster dose of the Hib conjugate vaccine
Detailed Description:
The non-inferiority of the immunogenicity safety and antibody persistence of Hib-MenCY-TT vaccine will be compared to ActHIB a monovalent Hib conjugate vaccine licensed in the US
All subjects will be vaccinated at 2 4 6 and 12 to 15 months The immunogenicity of the MenC and MenY antigens will be summarized
MenC and MenY immunogenicity will be compared to Menomune a quadrivalent meningococcal A C Y and W-135 plain polysaccharide vaccine licensed in the US administered to children 3 to 5 years of age
The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
All subjects will be vaccinated at 2 4 6 and 12 to 15 months The immunogenicity of the MenC and MenY antigens will be summarized
MenC and MenY immunogenicity will be compared to Menomune a quadrivalent meningococcal A C Y and W-135 plain polysaccharide vaccine licensed in the US administered to children 3 to 5 years of age
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 102015 | OTHER | GSK | None |