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| Name | Class |
|---|---|
| PPD, Part of Thermo Fisher Scientific | INDUSTRY |
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Purpose of the study is to evaluate pregnancy outcomes among women who received a dose of HEPLISAV-B within 28 days prior to conception or at any time during pregnancy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult Pregnant Women Exposed to HEPLISAV-B | Adult women who received a dose of HEPLISAV-B within 28 days prior to conception or at any time during pregnancy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HEPLISAV-B | Biological | This study is strictly observational. Administration of HEPLISAV-B, the schedule of office visits and all treatment regimens will be determined by the treating health care provider in the context of routine clinical care. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Major Congenital Malformations in Live-Born Infants. | Live-born infants will be followed to 12 months of age | |
| Rate of Still Births, Pre-Term, or Fetal Loss (Including Spontaneous Abortion) of any Gestational Age | Follow-up will end at the time of pregnancy outcome up to 9 months |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant Women
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Women 18 years of age or older exposed to HEPLISAV-B within 28 days of conception or at any time during pregnancy.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD Registry Office, Recruiting Nationwide | Wilmington | North Carolina | 28401 | United States |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D006505 | Hepatitis |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| ID | Term |
|---|---|
| C000726347 | Heplisav-B |
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| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |