Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2026-02-21 @ 4:42 AM
Study NCT ID:
NCT01571505
Status:
COMPLETED
Last Update Posted:
2017-08-31
First Post:
2012-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccines in INDIA (PROVIDE)
Sponsor:
International Vaccine Institute
Organization:
Study Overview
Official Title:
Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccines in INDIA
Status:
COMPLETED
Status Verified Date:
2017-08
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:
Oral polio and rotavirus vaccines are significantly less effective in children living in the developing world. Tropical enteropathy, which is associated with intestinal inflammation, decreased absorption and increased permeability, may contribute substantially to oral vaccine failure in developing country settings. Other possible causes of oral vaccine underperformance include malnutrition, interference with maternal or breast milk antibodies, changes in gut microbiota, and genetic susceptibility.The primary Objective of this study is to determine whether decreased vaccine responsiveness to oral poliovirus or rotavirus vaccines is associated with the presence of tropical enteropathy.
Detailed Description:
Intervention of this study is to vaccinate oral poliovirus vaccine and oral rotavirus vaccine to the child with two group; with inactivated poliovirus vaccine and without inactivated poliovirus vaccine. Rotavirus vaccines give to the child at 10 weeks of age and 17 weeks of age.
Study Oversight
Has Oversight DMC:
False
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?: