Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00334607
Status:
COMPLETED
Last Update Posted:
2016-11-04
First Post:
2006-06-07
Brief Title:
Study of 2 Doses of HRV Vaccine Given Concomitantly or Separately With Routine Vaccinations in Healthy Infants in USA
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Assess the Immunogenicity of 3 Doses of Pediarix Prevnar ActHIB Given to Healthy Infants When Administered With GSK Biologicals 2 Dose Oral Live Attenuated Human Rotavirus Vaccine Given During the Same Vaccination Visit or Separately
Status:
COMPLETED
Status Verified Date:
2016-11
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 aim of this this study is to confirm absence of immune interference between HRV vaccine and routine infant vaccinations currently in use in the USA
Detailed Description:
A phase III randomized multi-center study to assess the immunogenicity of three doses of Pediarix Prevnar and ActHIB given to healthy infants at 2 4 and 6 months of age when administered with GlaxoSmithKline GSK Biologicals two-dose oral live attenuated human rotavirus HRV vaccine given during the same vaccination visit at 2 and 4 months of age or given separately at 3 and 5 months of age
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