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Study objectives are to compare
Study hypotheses are that infants born to pregnant women who receive influenza immunization in late pregnancy will have
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inactivated influenza vaccine in pregnancy | Healthy pregnant women who elect to receive inactivated influenza vaccine in early pregnancy (< 20 weeks gestation) and their infants | ||
| No inactivated influenza vaccine during pregnancy | Healthy pregnant women who decline inactivated influenza vaccine in pregnancy and their infants |
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| Measure | Description | Time Frame |
|---|---|---|
| Influenza antibody titer levels in infants born to women who receive inactivated influenza vaccine in early pregnancy compared with late pregnancy and no immunization | Influenza titers will be measured on infant serum and breast milk samples by HAI assay and on maternal colostrum or breast milk if available by ELISA and neutralization assay | Infant antibody titers at delivery |
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Inclusion Criteria:
Pregnant women 18-45 years of age from 8-36 weeks gestation in good health as determined by medical history and recent physical exam who
Exclusion Criteria:
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Pregnant women and their infants receiving care at University of Utah Health Sciences (UUHS) will be recruited and followed.
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| Name | Affiliation | Role |
|---|---|---|
| Julie H. Shakib, DO, MS, MPH | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah Health Sciences Center | Salt Lake City | Utah | 84108 | United States |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |