Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
Study NCT ID:
NCT01621802
Status:
COMPLETED
Last Update Posted:
2019-11-25
First Post:
2012-06-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Subjects Four to Six Years of Age
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
Immunogenicity and Safety Study of GSK Biologicals' Combined Measles-mumps-rubella Vaccine in Subjects Four to Six Years of Age (209762)
Status:
COMPLETED
Status Verified Date:
2019-11
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:
The purpose of this study is to support licensure of GSK Biologicals' MMR vaccine (Priorix®) in the US by generating immunogenicity and safety data in contrast to the US standard of care, Merck's MMR vaccine (M-M-R®II), when given as a second dose to children four to six years of age.
Detailed Description:
The GSK Biologicals' MMR vaccine (Priorix®) and Merck's MMR vaccine (M-M-R®II) are referred to as Inv\_MMR vaccine and Com\_MMR vaccine respectively. 2 lots of the comparator vaccine (Com\_MMR\_L1 and Com\_MMR\_L2) will be used, but the 2 lots will be analysed as a pool.
The Inv\_MMR vaccine will be administered as a second dose to children who already received a first dose Com\_MMR vaccine. Since the second dose of a MMR vaccine in the US is routinely co-administered with DTaP-IPV vaccine (Kinrix®) and varicella vaccine (VV) (ProQuad® or Varivax®), some children will receive one dose of these vaccines along with either of the MMR vaccines.
The Inv\_MMR vaccine will be administered as a second dose to children who already received a first dose Com\_MMR vaccine. Since the second dose of a MMR vaccine in the US is routinely co-administered with DTaP-IPV vaccine (Kinrix®) and varicella vaccine (VV) (ProQuad® or Varivax®), some children will receive one dose of these vaccines along with either of the MMR vaccines.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2011-004638-32 | EUDRACT_NUMBER | None | View |