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The primary objective of this observational, comparative safety study is to evaluate the safety of the Novartis Pandemic Influenza A (H1N1) vaccine in pregnant women and their off spring, followed for up to 3 months of age as compared to pregnant women who have not received the Novartis Pandemic Influenza A (H1N1) vaccine. This study will be conducted at investigative sites within the Netherlands, Italy, and Argentina.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnancy women | Comparison of pregnancy outcomes between (Novartis) H1N1 vaccinated women and (Novartis) H1N1 unvaccinated women. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-intervention observational study | Other | Non-intervention observational study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Normal live-born delivery | 3 months follow-up on all live births | |
| Spontaneous and elective abortions | 3 months follow-up on all live births | |
| Congenital malformations | 3 months follow-up on all live births | |
| Pre-term birth (prematurity) | 3 months follow-up on all live births | |
| Low birth weight | 3 months follow-up on all live births | |
| Neonatal mortality | 3 months follow-up on all live births |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal complications of gestational diabetes, preeclampsia, maternal death | During pregnancy and post delivery |
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Inclusion Criteria:
Exclusion Criteria:
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Pregnant women
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Buenos Aires | 1706 | Argentina | ||||
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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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| Córdoba |
| X5000 |
| Argentina |
| Villa Nueva | 5519 | Argentina |
| Bari | 79124 | Italy |
| Cagliari | 09126 | Italy |
| Como | 22100 | Italy |
| Milan | 20126 | Italy |
| Milan | 20157 | Italy |
| Monza | 20052 | Italy |
| Prato | 59100 | Italy |
| Roma | 00135 | Italy |
| Rome | 00168 | Italy |
| Siena | 53100 | Italy |
| Trieste | 34100 | Italy |
| Udine | 33100 | Italy |
| Vicenza | 36100 | Italy |
| Podiumweg | Ilsselstein | Netherlands |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |