Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00289172
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2006-02-08
Brief Title:
Assess the Immunogenicity Safety of 2 Doses of Oral Live Attenuated Human RotaHRVVaccine in Healthy Infants in India
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Multicenter Study of the Immunogenicity Safety of 2 Doses of GSK Biologicals Oral Live Attenuated Human Rotavirus Vaccine RIX4414 as Primary Dosing of Healthy Infants in India Aged Approximately 8 Wks at the Time of the First Dose
Status:
COMPLETED
Status Verified Date:
2017-05
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:
Rotavirus disease is the most common cause of gastroenteritis and dehydration in young children worldwide The global public health burden has prompted the development of a human rotavirus vaccine against rotavirus disease by GlaxoSmithKline Biologicals This pre-registration study is undertaken to provide immunogenicity reactogenicity and safety data for the vaccine when used in Indian infants aged approximately 8 weeks at the time of the first dose
Detailed Description:
The study consists of two groups of children to be recruited in different centers in India One group will receive the HRV vaccine and one group will receive the placebo The vaccine or placebo will be administered starting at 8-12 weeks of age according to a two dose schedule 0 1 months schedule The study will consist of three visits A 8-day Day 0 - 7 follow-up period will be observed for general symptoms solicited in the study A 31-day Day 0 - 30 follow-up will be observed for other unsolicited symptoms Serious adverse events SAEs will be followed-up throughout the study A stool sample will be collected from the child at any point during the study if he she develops any GE
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