Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00316147
Status:
COMPLETED
Last Update Posted:
2016-09-28
First Post:
2006-02-21
Brief Title:
Immunogenicity Safety of GSKs Combined DTPa-HBV-IPVHib Vaccine in Indian Infants at 2 Diff Vaccination Schedules
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Phase IIIb Open Randomized Multicenter Study to Assess the Immunogenicity Safety of GSK Biologicals Combined DTPa-HBV-IPVHib Vaccine in Indian Infants When Given at 6-10-14 Weeks of Age or at 2-4-6 Months of Age
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:
In this study infants who were previously vaccinated with hepatitis B vaccine at birth will be randomly allocated into two groups
one group of subjects will receive diphtheria tetanus acellular pertussis- hepatitis B virus-inactivated poliovirusHaemophilus influenzae type b DTPa-HBV-IPVHib vaccine at 6-10-14 weeks of age
the second group of subjects will receive DTPa-HBV-IPVHib vaccine at 2-4-6 months of age
one group of subjects will receive diphtheria tetanus acellular pertussis- hepatitis B virus-inactivated poliovirusHaemophilus influenzae type b DTPa-HBV-IPVHib vaccine at 6-10-14 weeks of age
the second group of subjects will receive DTPa-HBV-IPVHib vaccine at 2-4-6 months of age
Detailed Description:
DTPa-HBV-IPVHib vaccine will be administered at two schedules ie 6-10-14 weeks of age OR 2-4-6 months of age in infants who were previously vaccinated with hepatitis B vaccine at birth The duration of the study will be approximately 3 months for each subject who will receive vaccination at 6-10-14 weeks of age and approximately 5 months for each subject who will receive vaccination at 2-4-6 months of age Intervention name Diphteria tetanus acellular pertussis hepatitis B poliovirus types 1 2 3 Haemophilus influenzae type b vaccine
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