| Methods |
Prospective cohort study assessing the safety of pandemic MF‐59 adjuvanted influenza vaccine (Focetria) during pregnancy |
| Participants |
Pregnant women recruited in midwife practices and hospitals in the Netherlands (n = 4281), Argentina (n = 239), and Italy (n = 9). Altogether, 4508 pregnant women were included: 2295 were vaccinated and 2213 were not immunised. There were 4522 live births and 18 intrauterine deaths (2310 born from vaccinated and 2213 from unvaccinated mothers). 3 months' follow‐up data were available for 4385 babies. |
| Interventions |
Monovalent pandemic H1N1, MF‐59 adjuvanted flu vaccine Focetria (Novartis Vaccine and Diagnostics, Cambridge, MA, USA). Among the 2295 vaccinated pregnant women, 1724 received 2 doses, 571 received 1 dose. |
| Outcomes |
Gestational diabetes Pre‐eclampsia Spontaneous abortion Stillbirth Live birth Low birth weight Preterm birth Neonatal death Congenital malformation |
| Notes |
"This study was supported by Novartis Vaccines and Diagnostics" |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| PCS/RCS ‐ selection exposed cohort
All outcomes |
Unclear risk |
Unclear |
| PCS/RCS ‐ selection non‐exposed cohort
All outcomes |
Unclear risk |
Unclear |
| PCS/RCS ‐ comparability
All outcomes |
High risk |
|
| PCS/RCS ‐ assessment of outcome
All outcomes |
Low risk |
|
| Summary assessment |
High risk |
Unclear |
