Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00140673
Status:
COMPLETED
Last Update Posted:
2019-12-30
First Post:
2005-08-31
Brief Title:
A Study to Test 2 Doses of the HRV Vaccine in Healthy Infants
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Placebo-controlled Multi-country Multi-center Study to Assess the Efficacy Safety Immunogenicity of 2 Doses of GSK Biologicals Oral Live Attenuated Human Rotavirus HRV Vaccine in Healthy Infants
Status:
COMPLETED
Status Verified Date:
2019-12
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 are 1 In a subset N 20 000 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 2 In all subjects N 60 000 to determine the safety of GSK Biologicals HRV vaccine with respect to definite intussusception IS within 31 days Day 0-Day 30 after each HRV vaccine dose
Detailed Description:
The study has two groups Group HRV and Group Placebo Two oral doses administered to healthy infants who are 6-13 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 A minimum 2-week interval was to be observed between HRV vaccine and OPV doses Of the total enrolled cohort of 60 000 subjects 20 000 subjects were followed for efficacy and safety until one year of age while 40 000 subjects were followed for safety only until 30-90 days after the second HRVplacebo dose A subset N approximately 13 000 of the 20 000 subjects are followed for efficacy and safety until 24 months of age From the 20 000 subjects followed for efficacy and safety a subset of 100 subjects per country center specific except Finland provided two blood sample to evaluate immunogenicity
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