Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00129116
Status:
COMPLETED
Last Update Posted:
2018-08-27
First Post:
2005-08-10
Brief Title:
3 Formulations of Hib-MenCY-TT Vaccine 1 Formulation of Hib-MenC-TT Vaccine Compared to Licensed Meningococcal Serogroup C Conjugate Vaccine Each Administered at 234 Mths of Age
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Phase II Open Partially Double-blind Randomised Controlled Multicentre Primary Vaccination Study to Evaluate the Immunogenicity Reactogenicity and Safety of Three Different Formulations of GSK Biologicals Combined Haemophilus Influenzae Type B-meningococcal Serogroups C and Y- Conjugate Vaccine and One Formulation of GSK Biologicals Haemophilus Influenzae Type B-meningococcal Serogroup C Conjugate Vaccine Each Given Concomitantly With InfanrixTM Penta Versus MeningitecTM Given Concomitantly With InfanrixTM Hexa in Infants According to a 2-3-4 Month Schedule
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 evaluated the safety and immunogenicity of 3 formulations of Hib-MenCY-TT vaccine and 1 formulation of Hib-MenC-TT vaccine compared to a control group receiving licensed meningococcal serogroup C conjugate vaccine each administered at 2 3 and 4 months of age Antibody persistence and immune responses to booster vaccinations were additionally assessed at 12 to 18 months of age
Detailed Description:
Primary booster vaccination study to evaluate the immunoreacto safety of 3 diff formulations of GSKBiocombined Haemophilus influenzae typeb-meningococcal serogroups C Y-conjugate vaccine one formulation of GSKBio Haemophilus influenzae typeb-meningococcal serogroup C conjugate vaccine each given concomitantly With Infanrix penta DTaP-IPV-HepB vaccine vs Meningitec meningococcal SerogroupC conjvaccine given concomitantly With Infanrix hexa DTaP-IPV-HepB-Hib vaccine in infants according a 2-3-4 mth schedule
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 |
|---|---|---|---|
| 100381 | OTHER | GSK | None |