pcb Håberg 2013.
Methods | Cohort study assessing the risk of neonatal death following exposure to pandemic monovalent H1N1 influenza vaccine or influenza virus during pregnancy | |
Participants | A total of 113,331 pregnant women | |
Interventions | Immunisation with pandemic monovalent H1N1 adjuvanted influenza vaccine Pandemrix (GSK) or Celvapan (not adjuvanted) | |
Outcomes | Foetal death | |
Notes | Government funded | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
PCS/RCS ‐ selection exposed cohort All outcomes | Unclear risk | Data link |
PCS/RCS ‐ selection non‐exposed cohort All outcomes | Unclear risk | Data link |
PCS/RCS ‐ comparability All outcomes | Unclear risk | Multivariate model |
PCS/RCS ‐ assessment of outcome All outcomes | Unclear risk | Data link |
Summary assessment | Unclear risk | Unclear risk of bias |