Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00134719
Status:
COMPLETED
Last Update Posted:
2018-07-19
First Post:
2005-08-10
Brief Title:
Hib-MenCY-TT Vaccine Study Compared to Licensed Hib and Meningococcal Serogroup C Conjugate Vaccines
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Multicentre Primary Booster Vaccination Study of GSK Biologicals Hib-MenCY-TT Conjugate Vaccine vs ActHIB MenC Conjugate Licensed Vaccine When Given According to the 2-4-6 Month Schedule to Healthy Infants With Booster Dose at 12 to 15 Months
Status:
COMPLETED
Status Verified Date:
2018-05
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 Hib-MenCY-TT vaccine compared to control groups receiving licensed Hib or MenC conjugate vaccines each administered at 2 4 6 and 12 to 15 months of age Co-administration with live attenuated measles mumps and rubella combination vaccine and with live attenuated varicella vaccine will be assessed with administration of the booster dose The Protocol Posting has been updated in order to comply with the FDA Amendment Act September 2007
Detailed Description:
The study will be conducted in 2 stages a 3-dose primary vaccination at 2 4 and 6 months of age and a booster vaccination at 12 to 15 months of age All subjects will have 3 blood samples taken Half of the subjects of each group will have a blood sample taken just prior to the administration of the third dose of the primary vaccination and the other half of the subjects of each group will have a blood sample taken at one month after the third vaccine dose of the primary vaccination phase In addition all subjects of all groups will have a blood sample taken before and 42 days after administration of the booster dose
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 |
|---|---|---|---|
| 102371 | OTHER | GSK | None |