| Methods |
Prospective cohort study based on data from the Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy (D) carried out during the 2009 to 2010 pandemic |
| Participants |
Pregnant women who received consultation regarding reproductive safety of medical products, planned pregnancy, and lactation from the Institute for Clinical Teratology and Drug Risk Assessment. Out of the initial population (n = 16,788), 323 participants received influenza vaccine and completed the follow‐up. A randomly selected group of 1329 non‐vaccinated women formed the control group. |
| Interventions |
Non‐adjuvanted split‐virion vaccine CSL H1N1 Pandemic Influenza Vaccine (CSL Biotherapies) approved by the responsible national authority (Paul‐Ehrlich‐Institut) in November 2009 exclusively for the vaccination of pregnant women (216/323). MF59‐adjuvanted monovalent H1N1 vaccine (2/32). Pandemrix (GlaxoSmithKline) AS03‐adjuvanted monovalent split‐virion influenza vaccine (90/323). Unknown vaccine (15/323). |
| Outcomes |
Abortion, preterm birth, malformations |
| Notes |
"This study was supported by the German Federal Institute for Vaccines and Biomedicines (Paul‐Ehrlich‐Institut), Langen, Germany" |
| 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 |
Unclear risk |
Unclear |
| PCS/RCS ‐ assessment of outcome
All outcomes |
Low risk |
Low |
| Summary assessment |
Unclear risk |
Unclear |
