Fluenza during pregnancy and keener to avoid infection than the general population. We did not evidence an impact of A/H1N1 influenza infection on maternal and perinatal outcomes but only few women experienced flu. The pregnancy outcomes did not appear to be seriously affected by pandemic and were comparable with those of the French perinatal survey during non pandemic periods [21]. In the national French registry created to screen MedChemExpress 94-09-7 Peptide M pregnant women with laboratory-confirmed A/H1N1 2009 influenza, the morbidity and ICU management was increased mainly in at-risk patients [22]; maternal mortality remained low 15900046 and was lower than mortality rates observed in other countries [23,24]. The UK study of 256 pregnant women admitted to hospital with confirmed A/ H1N1 influenza evidenced a significantly high risk of poor pregnancy outcome with higher perinatal mortality in infants born from infected vs. uninfected women (39/1000 vs. 7/1000 births, respectively) [25]. The low number of laboratorydocumented influenza infections in our cohort does not allow extrapolating our results on maternal and perinatal outcomes. However, the design of our study is adapted to assess the incidence of flu in this population of pregnant women and the impact on less severe pregnancy outcomes. The differences of results between our study and others could be also explained by the characteristics of the population, health system and pandemic characteristics. When it appeared that the infection rate of the pandemic was less than expected, the inclusions in the study were stopped but COFLUPREG cohort was nevertheless pursued since there was an opportunity to assess immunogenicity, safety and consequences of vaccination on outcomes of pregnancies. Indeed, vaccine safety is a special concern in pregnant women. Previous studies suggested that inactivated seasonal influenza vaccines were safe during pregnancy [26?1]. Data were lacking in pregnant women for the pandemic A/H1N1 2009 influenza vaccine, especially studies with comparative data on pregnancy outcome between vaccinated and non-vaccinated women. A French study in 107 pregnant women who received one dose of non-adjuvanted pandemic A/H1N1 2009 influenza vaccine between 22 and 32 weeks of gestation did not evidence adverse events of special interest [32]. The prospective study of Tavares 23727046 et al with AS03-adjuvanted pandemic A/H1N1 2009 influenza vaccine in 267 pregnant women did not evidence an increase of the risk of adverse pregnancy outcomes (spontaneous abortion, congenital abnormalities, preterm delivery, low birth weight neonates or maternal complications) [33]. In a large cohort study conducted in Denmark among 54 585 pregnant women (7062 vaccinated women), no evidence of an increased risk of fetal death associated with exposure to an adjuvanted pandemic A/H1N1 2009 influenza vaccine during pregnancy was found [34]. In the present study, we confirm the safety of one injection of the non-adjuvanted A/H1N1 2009 influenza vaccine. Indeed, among the 320 pregnant women who were vaccinated, no significant difference on maternal and perinatal outcomes was observed in comparison with the group of 557 pregnant women who were not vaccinated. Among vaccinated women, the seroprotection rate (defined as titers above 1:40) at delivery was only 69.9 . In the PREFLUVAC study, performed with the same vaccine at the same period, the women were vaccinated between the 22th and 26th weeks of pregnancy and 92 of them achieved seroprotecti.Fluenza during pregnancy and keener to avoid infection than the general population. We did not evidence an impact of A/H1N1 influenza infection on maternal and perinatal outcomes but only few women experienced flu. The pregnancy outcomes did not appear to be seriously affected by pandemic and were comparable with those of the French perinatal survey during non pandemic periods [21]. In the national French registry created to screen pregnant women with laboratory-confirmed A/H1N1 2009 influenza, the morbidity and ICU management was increased mainly in at-risk patients [22]; maternal mortality remained low 15900046 and was lower than mortality rates observed in other countries [23,24]. The UK study of 256 pregnant women admitted to hospital with confirmed A/ H1N1 influenza evidenced a significantly high risk of poor pregnancy outcome with higher perinatal mortality in infants born from infected vs. uninfected women (39/1000 vs. 7/1000 births, respectively) [25]. The low number of laboratorydocumented influenza infections in our cohort does not allow extrapolating our results on maternal and perinatal outcomes. However, the design of our study is adapted to assess the incidence of flu in this population of pregnant women and the impact on less severe pregnancy outcomes. The differences of results between our study and others could be also explained by the characteristics of the population, health system and pandemic characteristics. When it appeared that the infection rate of the pandemic was less than expected, the inclusions in the study were stopped but COFLUPREG cohort was nevertheless pursued since there was an opportunity to assess immunogenicity, safety and consequences of vaccination on outcomes of pregnancies. Indeed, vaccine safety is a special concern in pregnant women. Previous studies suggested that inactivated seasonal influenza vaccines were safe during pregnancy [26?1]. Data were lacking in pregnant women for the pandemic A/H1N1 2009 influenza vaccine, especially studies with comparative data on pregnancy outcome between vaccinated and non-vaccinated women. A French study in 107 pregnant women who received one dose of non-adjuvanted pandemic A/H1N1 2009 influenza vaccine between 22 and 32 weeks of gestation did not evidence adverse events of special interest [32]. The prospective study of Tavares 23727046 et al with AS03-adjuvanted pandemic A/H1N1 2009 influenza vaccine in 267 pregnant women did not evidence an increase of the risk of adverse pregnancy outcomes (spontaneous abortion, congenital abnormalities, preterm delivery, low birth weight neonates or maternal complications) [33]. In a large cohort study conducted in Denmark among 54 585 pregnant women (7062 vaccinated women), no evidence of an increased risk of fetal death associated with exposure to an adjuvanted pandemic A/H1N1 2009 influenza vaccine during pregnancy was found [34]. In the present study, we confirm the safety of one injection of the non-adjuvanted A/H1N1 2009 influenza vaccine. Indeed, among the 320 pregnant women who were vaccinated, no significant difference on maternal and perinatal outcomes was observed in comparison with the group of 557 pregnant women who were not vaccinated. Among vaccinated women, the seroprotection rate (defined as titers above 1:40) at delivery was only 69.9 . In the PREFLUVAC study, performed with the same vaccine at the same period, the women were vaccinated between the 22th and 26th weeks of pregnancy and 92 of them achieved seroprotecti.