| Methods |
Retrospective cohort study testing the safety of live attenuated influenza vaccine when administered during pregnancy |
| Participants |
Pregnant women (n = 834,999) identified by means of a safety database (LifeLink Health Plan Claims Database, Norwalk, USA) between October 2003 and September 2009. Of these, 138 received immunisation with live attenuated influenza vaccine during their pregnancy. |
| Interventions |
Live attenuated influenza vaccine |
| Outcomes |
Hospitalisation and emergency department visits within 42 days after immunisation |
| Notes |
"This research was funded by MedImmune, LLC, Gaithersburg, MD. As part of a consulting agreement with RTI Health Solutions, MedImmune provided funding to support protocol development, data collection, analysis, and manuscript development activities associated with this manuscript. Editorial assistance in formatting the manuscript for submission was provided by Sue Myers, MSc, and Gerard P. Johnson, PhD, of Complete Healthcare Communications, Inc. (Chadds Ford, PA) and was funded by MedImmune, LLC" |
| 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 |
|
