Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00134732
Status:
COMPLETED
Last Update Posted:
2016-09-23
First Post:
2005-08-24
Brief Title:
Study of 2 Doses of Oral Live Attenuated Human Rotavirus HRV Vaccine for the Prophylaxis of Rotavirus Gastroenteritis
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Assess the Immunogenicity Safety Reactogenicity of 2 Doses of GSK Biologicals Oral Live Attenuated Human Rotavirus HRV Vaccine in Healthy Infants 6-12 Weeks of Age at First Dose Previously Uninfected With Human Rotavirus
Status:
COMPLETED
Status Verified Date:
2016-09
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 RV is the most important cause of acute gastroenteritis GE requiring the hospitalization of infants and young children in developed and developing countries and can be a frequent cause of death in children less than 5 years of age estimated nearly 500000 annual deaths worldwide GlaxoSmithKline GSK Biologicals has developed a vaccine against human rotavirus gastroenteritis This study will provide data for Korean regulatory authorities about the immunogenicity and safety of this vaccine in Korean children aged 2 months at the time of the first dose
Detailed Description:
The study consists of two groups of children recruited in different centers in Korea One group will receive the HRV vaccine and one group will receive the placebo The vaccine or placebo will be administered starting at 2 months of age according to a two dose schedule 0 2 months The study will consist of three visits At the first visit one blood sample will be taken before vaccination and the first dose will be administered At the second visit 2 months after first dose the second vaccine will be administered At the third visit 2 months after second dose a blood sample will be taken A 15-day Day 0 - 14 follow-up period will be observed for general symptoms solicited in the study fever fussinessirritability diarrhea vomiting loss of appetite and coughrunny nose A 43-day Day 0 - 42 follow-up will be observed for other unsolicited symptoms Serious adverse events will be followed-up throughout the study A stool sample should be collected from the child at any point during the study if heshe 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