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| Name | Class |
|---|---|
| Bill and Melinda Gates Foundation | OTHER |
| National Institute of Cholera and Enteric Diseases, India | OTHER |
| University of Virginia | OTHER |
| University of Vermont |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IPV vaccination | Experimental | Randomized IPV vaccination to children at the age of 39 weeks. |
|
| OPV vaccination | Placebo Comparator | Randomized OPV vaccination to children at the age of 39 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IPV vaccination | Biological | Randomized IPV or OPV to children aged at 39weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vaccine immunogenicity of oral vaccines (Oral Polio Vaccine and Rotavirus Vaccine) with the presence of tropical enteropathy using Lactose/Mannitol ratio in urine. | Responsiveness of oral vaccines compare with Tropical Enteropathy and without Tropical Enteropathy; using lactose/mannitol ratio. | Birth to one year |
| Measure | Description | Time Frame |
|---|---|---|
| Systemic immune responses (neutralizing antibodies) of impact of an inactivated polio vaccine (IPV) and polio vaccine boost following vaccination with oral polio vaccine (OPV). | Birth to one year | |
| Mucosal immune responses (shedding OPV vaccine virus) of impact of an inactivated polio vaccine (IPV) and polio vaccine boost following vaccination with oral polio vaccine (OPV). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ayan Dey, Ph.D | International Vaccine Institute | Principal Investigator |
| William Petri, M.D | University of Virginia | Principal Investigator |
| Beth Kirkpatrick, M.D. | University of Vermont | Principal Investigator |
| Suman Kanungo, M.D. | National Institute of Cholera and Enteric Diseases, India | Principal Investigator |
| Ranjan K Nandy, M.D. | National Institute of Cholera and Enteric Diseases, India | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute of Cholera and Enteric Diseases | Kolkata | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28194449 | Result | Kanungo S, Kim DR, Haldar B, Snider C, Nalavade U, Kim SA, Park JY, Sinha A, Mallick AH, Manna B, Sur D, Nandy RK, Deshpande JM, Czerkinsky C, Wierzba TF, Petri WA Jr, Ali M, Dey A. Comparison of IPV to tOPV week 39 boost of primary OPV vaccination in Indian infants: an open labelled randomized controlled trial. Heliyon. 2017 Jan 9;3(1):e00223. doi: 10.1016/j.heliyon.2016.e00223. eCollection 2017 Jan. |
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| ID | Term |
|---|---|
| D011051 | Poliomyelitis |
| D013182 | Sprue, Tropical |
| ID | Term |
|---|---|
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
| D004769 | Enterovirus Infections |
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| ID | Term |
|---|---|
| D000375 | Aging |
| ID | Term |
|---|---|
| D048788 | Growth and Development |
| D010829 | Physiological Phenomena |
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| OTHER |
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| Birth to one year |
| D010850 |
| Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009468 | Neuromuscular Diseases |
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |