NCT01571505

Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccines in INDIA (PROVIDE)

Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccines in INDIA

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 372 (actual)
• Sponsor: International Vaccine Institute · Academic / Other
• Sex: All
• Age: 42 Days – 49 Days
• Healthy volunteers: Accepted

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.

Conditions

• Poliomyelitis
• Tropical Enteropathy

Interventions

Type	Name	Description
BIOLOGICAL	IPV vaccination	Randomized IPV or OPV to children aged at 39weeks.

Timeline

• Start date: 2012-03-01
• Primary completion: 2016-11-30
• Completion: 2016-11-30
• First posted: 2012-04-05
• Last updated: 2017-08-31

Locations

1 site across 1 country: India