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. 2018 Feb 1;2018(2):CD001269. doi: 10.1002/14651858.CD001269.pub6

pcb Källén 2012.

Methods Retrospective cohort study assessing the effect on newborn outcomes of pandemic squalene adjuvanted H1N1 vaccine
Participants The total number of vaccinated women was 18,612 having 18,844 infants (vaccination group, pandemic H1N1 Pandemrix). These women were compared with 136,914 women having 138,931 infants who gave birth after September 2009 and before the end of 2010 (non‐vaccinated group) and with 83,298 women having 84,484 infants who gave birth in the year 2009 before October (pre‐vaccination group).
Interventions Pandemrix (GlaxoSmithKline; Brentford, Middlesex, UK) containing inactivated split influenza virus A/California/07/2009, squalene adjuvant and thiomersal preservative
Outcomes

  • Stillbirth

  • Preterm birth

  • Low birth weight

  • Small for gestational age

  • Congenital malformations
Notes "No specific funding was obtained for this study"
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 Unclear risk Unclear
Summary assessment High risk