Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00289796
Status:
COMPLETED
Last Update Posted:
2017-02-08
First Post:
2006-02-09
Brief Title:
Assess Feasibility of an Acellular Pertussis Vaccine Pa Given Soon After Birth Followed by 3-dose Primary Vaccination With the DTPa-HBV-IPVHib Vaccine
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Assess the Feasibility of an Investigational Vaccination Regimen Compared to a 3-dose Primary Vaccination With GSK Biologicals Infanrix Hexa DTPa-HBV-IPVHib Vaccine Following Hepatitis B Vaccination at Birth Primary Vaccination is Followed in the 2nd Year of Life by a Booster Dose of Infanrix-hexa
Status:
COMPLETED
Status Verified Date:
2017-02
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 assess immunogenicity safety and reactogenicity of primary and booster vaccination
Detailed Description:
There will be two groups in this study
one group will receive a birth dose of Pa vaccine and 3 doses of DTPa-HBV-IPVHib vaccine as primary vaccination and a dose of DTPa-HBV-IPVHib vaccine as booster vaccination
the control group will receive a birth dose of hepatitis B vaccine and 3 doses of DTPa-HBV-IPVHib vaccine as primary vaccination and a dose of DTPa-HBV-IPVHib vaccine as booster vaccination
one group will receive a birth dose of Pa vaccine and 3 doses of DTPa-HBV-IPVHib vaccine as primary vaccination and a dose of DTPa-HBV-IPVHib vaccine as booster vaccination
the control group will receive a birth dose of hepatitis B vaccine and 3 doses of DTPa-HBV-IPVHib vaccine as primary vaccination and a dose of DTPa-HBV-IPVHib vaccine as booster vaccination
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 |
|---|---|---|---|
| 105752 | OTHER | GSK | None |