Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00139347
Status:
COMPLETED
Last Update Posted:
2016-10-28
First Post:
2005-08-30
Brief Title:
Study of 2 Doses of HRV Vaccine Given Concomitantly With Routine EPI Vaccinations Including OPV in Healthy Infants
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Multi-country Multi-center Study to Assess the Efficacy Immunogenicity Safety of Two Doses of GSK Biologicals Oral Live Attenuated HRV Vaccine Given Concomitantly With Routine EPI Vaccinations Including OPV in Healthy Infants
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:
The main objectives of this study is to determine vaccine efficacy against severe rotavirus RV gastroenteritis GE during the period starting from 2 weeks after Dose 2 until one year of age
Detailed Description:
The study has two groups Group HRV and Group Placebo Two oral doses administered to healthy infants who are 6-12 weeks of age at the time of Dose 1 according to a 0 1 to 2-month schedule Routine EPI vaccinations are given at the discretion of the investigator and according to local National Plans of Immunisation schedule in each participating country
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