Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00226499
Status:
COMPLETED
Last Update Posted:
2019-09-23
First Post:
2005-09-23
Brief Title:
Evaluate Vaccine Against Chickenpox and a Combined Vaccine Against 4 Viral Childhood Diseases Measles Mumps Rubella and Chickenpox
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Study in Healthy Children 2 Years to Evaluate the Safety and Efficacy of GSK Biologicals Live Attenuated Varicella Vaccine VarilrixTM and of GSK Biologicals Combined Measles-Mumps-Rubella-Varicella Vaccine
Status:
COMPLETED
Status Verified Date:
2019-08
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:
An observer-blind study to evaluate GlaxoSmithKline Biologicals live attenuated varicella vaccine and GlaxoSmithKline Biologicals combined measles-mumps-rubella-varicella vaccine in the prevention of varicella disease in children The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
Detailed Description:
According to treatment group allocation participants will receive study vaccines and be followed for antibody titres and occurrence of varicella disease
This study is conducted in 2 phases Phase A includes the vaccination period and an observation period for efficacy The efficacy endpoints will be evaluated over at least two years after vaccination During this period the immunogenicity endpoints will be evaluated with respect to the immune response 43 days after vaccination and the persistence of antibodies over two years to varicella for all subjects and to measles mumps and rubella for a subset of subjects Regarding the safety endpoints SAEs including any complicated varicella cases if observed will be assessed for all subjects during the whole Phase A duration whereas solicited local and general and unsolicited adverse events will be assessed in a subset of subjects within a 43-day period after vaccination
Phase B is an extension of Phase A It is a long-term follow-up until Year 10 to examine the long-term efficacy of the study vaccines against clinical varicella disease as well as the long-term persistence of antibodies to varicella for all subjects and to measles mumps and rubella in a subset of subjects after vaccination
This study is conducted in 2 phases Phase A includes the vaccination period and an observation period for efficacy The efficacy endpoints will be evaluated over at least two years after vaccination During this period the immunogenicity endpoints will be evaluated with respect to the immune response 43 days after vaccination and the persistence of antibodies over two years to varicella for all subjects and to measles mumps and rubella for a subset of subjects Regarding the safety endpoints SAEs including any complicated varicella cases if observed will be assessed for all subjects during the whole Phase A duration whereas solicited local and general and unsolicited adverse events will be assessed in a subset of subjects within a 43-day period after vaccination
Phase B is an extension of Phase A It is a long-term follow-up until Year 10 to examine the long-term efficacy of the study vaccines against clinical varicella disease as well as the long-term persistence of antibodies to varicella for all subjects and to measles mumps and rubella in a subset of subjects after vaccination
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 104105 EXT FU Y2 | OTHER | None | None |
| 103494 EXT FU Y1 | OTHER | None | None |
| 104106 EXT FU Y4-Y6-Y8-Y10 | OTHER | None | None |
| 2004-002676-41 | EUDRACT_NUMBER | GSK | None |