Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00197015
Status:
COMPLETED
Last Update Posted:
2018-07-31
First Post:
2005-09-13
Brief Title:
Immunogenicity Safety of Hepatitis A Vaccine Co-admin With a MeaslesMumpsRubella a Varicella Vaccine in Children
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Immunogenicity Safety of GSK Biologicals Inactivated Hepatitis A Vaccine Havrix Co-administered With Merck Company Inc Measles-Mumps-Rubella Vaccine M-M-RII Merck Co Varicella Vaccine VARIVAX to Children 15 Months of Age
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 is a study to evaluate the immune response and safety of GSK Biologicals 2-dose inactivated hepatitis A vaccine when administered with a measlesmumpsrubella vaccine and a varicella chickenpox vaccine in children as young as 15 months of age
The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
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 MMR II and Varivax The three groups evaluated are 1 Havrix alone 2 Havrix MMR II and Varivax and 3 MMR II and Varivax 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