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| Name | Class |
|---|---|
| Aga Khan University | OTHER |
| Wageningen University | OTHER |
| University of Padova | OTHER |
| Centers for Disease Control and Prevention |
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This is a nested case-control study within an ongoing rotavirus vaccine immunogenicity trial in Karachi, Pakistan. The primary study aim is to compare the fecal microbiota composition and diversity of infants who do (control) and do not (case) demonstrate immune seroconversion to rotavirus vaccination. The infants will be matched for vaccination dose, age and breast-feeding practices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rotavirus (Rotarix TM) vaccination | Infants who received rotavirus vaccination (Rotarix TM) at 6 and 10 weeks, 10 and 14 weeks or 6,10, and 14 weeks. This is a nested study and infants received the vaccination in the overarching study: The Immunogenicity of ROtavirus Vaccine Under Different Age Schedules and the Impact of Withholding Breast Feeding around the Time of Vaccination on the Immunogenicity of Rotarix Vaccine (clinicaltrials.gov: NCT01199874) |
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| Measure | Description | Time Frame |
|---|---|---|
| differences in fecal microbiota composition | The primary study objective is to see if there are significant differences in the fecal microbiota composition between rotavirus vaccine (Rotarix TM) immune responders (defined as anti-RV IgA antibodies at a concentration of > or = to 20 U/ml in a previously seronegative individual 4 weeks after the last Rotarix dose) and rotavirus vaccine immune non-responders (defined as anti-RV IgA antibodies at a concentration of <20 U/mL 4 weeks after the last Rotarix dose) | 2 years |
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Inclusion Criteria:
Overarching study (NCT01199874)inclusion criteria:
Exclusion Criteria:
Overarching study (NCT01199874)exclusion criteria
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Infants living in a peri-urban slum outside of Karachi, Pakistan
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| Name | Affiliation | Role |
|---|---|---|
| Vanessa C Harris, MD | Amsterdam Institute for Global Health and Development; Academic Medical Center, Amsterdam | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aga Khan University | Karachi | 74800 | Pakistan |
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| FED |
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