Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00197236
Status:
COMPLETED
Last Update Posted:
2018-08-20
First Post:
2005-09-15
Brief Title:
Immunogenicity and Safety of Havrix Co-Administered With a Diphtheria Tetanus and Pertussis and a Haemophilus b Vaccine in Children Aged 15 Months
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Immunogenicity and Safety of GSK Biologicals Inactivated Hepatitis A Vaccine Havrix Co-administered With GSK Biologicals DTaP Vaccine Infanrix and Aventis Pasteurs Haemophilus b Conjugate Vaccine ActHIB in Healthy Children 15 Months of Age
Status:
COMPLETED
Status Verified Date:
2017-01
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 is a study to evaluate the immune response and safety of GSK Biologicals 2-dose inactivated hepatitis A vaccine when administered with a diphtheria tetanus and pertussis combination DTaP vaccine and a Haemophilus influenza type B Hib vaccine in children 15 months of age The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
Detailed Description:
An open controlled comparison of Havrix administered alone or with Infanrix and ActHIB The three groups evaluated are 1 Havrix alone 2 Havrix Infanrix and ActHIB and 3 Infanrix and ActHIB followed by Havrix one month later
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