Background: A(H1N1)v2009 influenza vaccination of pregnant women was a challenge for health care providers, as little safety data were available.
Methods: We prospectively followed the pregnancies of women who were vaccinated at any time during pregnancy or ≤ 4 weeks prior to conception and compared these outcomes to a control cohort matched by the estimated date of birth. Primary endpoints: rate of spontaneous abortion and major malformations. Secondary endpoints: preeclampsia, gestational age at birth, and birth weight.
Results: Pregnancy outcome of 323 women immunized with adjuvanted or non-adjuvanted A(H1N1)v2009 influenza vaccines from 2009-09-28 to 2010-03-31 were compared to 1329 control subjects. The risk for spontaneous abortions (HR 0.89; 95% CI 0.36-2.19) and the rate of major malformations (all trimesters: OR 0.87; 95% CI 0.38-1.77; preconception and first trimester exposure: OR 0.79; 95% CI 0.13-2.64) did not vary between the two cohorts. Furthermore, there was no increase in preeclampsia, prematurity, and intrauterine growth retardation in the vaccinated cohort.
Conclusion: The results of our study do not indicate a risk for the pregnant woman and the developing embryo/fetus after H1N1 vaccination. We provide and apply methods novel in observational studies on pregnancy outcome, especially if a single dose exposure is investigated.
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http://dx.doi.org/10.1016/j.vaccine.2012.04.081 | DOI Listing |
Drug Saf
June 2013
Service de Pharmacologie clinique, Centre Régional de PharmacoVigilance et de Renseignement sur les Médicaments, CHU de Poitiers, 2 rue de la Milétrie, 86021 Poitiers, France.
Background: In October 2009, in the context of an A(H1N1)v2009 influenza pandemic, a vaccination campaign was launched in France, in which one of the priority groups was pregnant women, on account of the high risk of developing complications following infection by this virus.
Objective: The aim of this multicentric, prospective, observational study was to assess safety and pregnancy outcomes in a cohort of pregnant women when receiving the A(H1N1)v2009 influenza pandemic vaccine.
Methods: This was a prospective study that followed up pregnant women recruited mainly in vaccination centres and maternity departments.
Acta Clin Belg
July 2012
Laboratoire de Microbiologie, Secteur de Virologie, Centre Hospitalier Universitaire Saint-Pierre, Bruxelles, Belgium.
Purpose: Evaluation of the performance of two rapid (15') antigen detection tests (RAT), BinaxNOW Influenza A&B and Coris Influ-A&B Respi-Strip for the detection of A(H1N1)v2009.
Study Design: Between July 2009 and November 2009, 4105 respiratory specimens from patients with influenza-like illness attending seven public hospitals in Brussels were prospectively examined by two immunochromatographic RAT, followed by viral culture and/or specific real-time RT-PCR.
Results: Samples consisted predominantly of nasopharyngeal aspirates (NPA-41%), nasopharyngeal (NPS-37%) and throat swabs (TS-14%).
Vaccine
June 2012
Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy, Charité - Universitätsmedizin Berlin, Germany.
Background: A(H1N1)v2009 influenza vaccination of pregnant women was a challenge for health care providers, as little safety data were available.
Methods: We prospectively followed the pregnancies of women who were vaccinated at any time during pregnancy or ≤ 4 weeks prior to conception and compared these outcomes to a control cohort matched by the estimated date of birth. Primary endpoints: rate of spontaneous abortion and major malformations.
Bull Soc Pathol Exot
May 2011
Service De Réanimation Polyvalente, Centre Hospitalier Félix-guyon, Chr Réunion, F-97405, Saint-Denis, France.
In the Southern hemisphere, Réunion Island acts as a sentinel for infections preferentially occurring during the austral winter that are likely to reach the Northern hemisphere a few months later. We relate the main features concerning patients that were admitted during years 2009 and 2010 in our intensive care unit with an A(H1N1)v2009 infection, mainly for acute respiratory distress. Demographic, clinical, and biological data as well as given medications and outcome were prospectively collected among all PCR-confirmed influenza-infected patients.
View Article and Find Full Text PDFBull Soc Pathol Exot
May 2011
Service De Réanimation Polyvalente, Site Centre Hospitalier Félix-Guyon, CHR de la Réunion, F-97405, Saint-Denis, Réunion, France.
A 19-year-old patient admitted in an oncology unit for an autograft (Hodgkin disease), developed on day 20 a fatal acute respiratory failure and multiple organ failure due to an infection of the A(H1N1)v2009 virus, which was acquired in the hospital, despite partial preventive measures. At that time, the specific vaccine was not available in Réunion. We discuss the nosocomial origin of the infection.
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