A(H1N1)v2009: a controlled observational prospective cohort study on vaccine safety in pregnancy

Vaccine
Marc OppermannChristof Schaefer

Abstract

A(H1N1)v2009 influenza vaccination of pregnant women was a challenge for health care providers, as little safety data were available. 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. 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. 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 studi...Continue Reading

References

Jun 12, 2003·Birth Defects Research. Part A, Clinical and Molecular Teratology·Sonja A RasmussenUNKNOWN National Birth Defects Prevention Study
Aug 5, 2003·Journal of Reproductive Immunology·Shigeru Saito, Masatoshi Sakai
Nov 11, 2003·American Journal of Medical Genetics. Part a·Johannes H M MerksRaoul C M Hennekam
Dec 25, 2007·The Lancet Infectious Diseases·Tippi K MakDina Pfeifer
Jul 1, 2008·Reproductive Toxicology·Christof SchaeferCorinna Weber-Schoendorfer
Jun 12, 2009·Vaccine·Danuta M Skowronski, Gaston De Serres
Aug 1, 2009·Lancet·Denise J JamiesonUNKNOWN Novel Influenza A (H1N1) Pregnancy Working Group
Feb 12, 2010·Zeitschrift für Geburtshilfe und Neonatologie·M VoigtG Jorch
Jan 13, 2011·Statistics in Medicine·Ian R WhiteAngela M Wood
Feb 25, 2011·American Journal of Obstetrics and Gynecology·Laura G MosbyDenise J Jamieson
Apr 6, 2011·Current Hypertension Reports·Eric M George, Joey P Granger

❮ Previous
Next ❯

Citations

May 31, 2014·BMJ : British Medical Journal·Francesco TrottaGiuseppe Traversa
Jul 13, 2014·Human Reproduction Update·Azure N FaucetteKang Chen
May 3, 2013·Obstetrics and Gynecology·Ava Marie S ConlinNancy F Crum-Cianflone
Aug 8, 2013·Obstetrics and Gynecology·Elyse Olshen KharbandaUNKNOWN Vaccine Safety Datalink Team
Mar 22, 2013·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·F ChavantM C Pérault-Pochat
Feb 5, 2013·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Mark J AbzugUNKNOWN International Maternal Pediatric Adolescent AIDS Clinical Trials Group P1086 Protocol Team
Mar 20, 2013·Current Opinion in Infectious Diseases·Benjamin LindseyChristine Jones
Sep 26, 2012·Expert Review of Vaccines·Pedro L MoroKaren Broder
Sep 26, 2012·Expert Review of Vaccines·Michi Hisano, Koushi Yamaguchi
Nov 8, 2013·Expert Review of Vaccines·Deshayne B FellShelly McNeil
Nov 5, 2014·Expert Opinion on Drug Safety·Paul LoubetOdile Launay
Nov 10, 2013·Obstetrics and Gynecology·Pedro L MoroClaudia Vellozzi
May 28, 2015·Acta Obstetricia Et Gynecologica Scandinavica·Wouter J MeijerAnnemarie M J Wensing
Oct 8, 2015·Obstetrics and Gynecology·Konstantinos A PolyzosMatthew E Falagas
Aug 21, 2012·BJOG : an International Journal of Obstetrics and Gynaecology·B Källén, P O Olausson
Jul 22, 2014·BJOG : an International Journal of Obstetrics and Gynaecology·D B FellD Buckeridge
Aug 13, 2015·Human Vaccines & Immunotherapeutics·Marta C Nunes, Shabir A Madhi
Feb 25, 2015·Journal of Infection and Chemotherapy : Official Journal of the Japan Society of Chemotherapy·Satoshi TakedaKoushi Yamaguchi
Apr 20, 2014·Vaccine·Allison L NalewayUNKNOWN Vaccine Safety Datalink and Pregnancy and Influenza Project
May 6, 2014·European Journal of Obstetrics, Gynecology, and Reproductive Biology·Brian J ClearyFionnuala McAuliffe
Jun 2, 2016·Human Vaccines & Immunotherapeutics·Jennifer A BeelerSaad B Omer
Apr 5, 2014·Thérapie·Thierry VialNathalie Bernard
Aug 20, 2016·Human Vaccines & Immunotherapeutics·Annette K Regan
Jul 28, 2016·Human Vaccines & Immunotherapeutics·G AmirthalingamM Ramsay
Apr 14, 2016·Expert Review of Vaccines·Varun K Phadke, Saad B Omer
Feb 2, 2018·The Cochrane Database of Systematic Reviews·Vittorio DemicheliCarlo Di Pietrantonj
Nov 2, 2018·Human Vaccines & Immunotherapeutics·Michelle L GilesAllen Cheng
May 30, 2013·European Journal of Epidemiology·Jonas F LudvigssonOlof Stephansson
Mar 14, 2014·The Cochrane Database of Systematic Reviews·Vittorio DemicheliCarlo Di Pietrantonj
Aug 24, 2019·MMWR. Recommendations and Reports : Morbidity and Mortality Weekly Report. Recommendations and Reports·Lisa A GrohskopfDaniel B Jernigan
Nov 18, 2017·International Journal of Gynaecology and Obstetrics : the Official Organ of the International Federation of Gynaecology and Obstetrics·Chuan ZhangXin Sun
Aug 22, 2020·MMWR. Recommendations and Reports : Morbidity and Mortality Weekly Report. Recommendations and Reports·Lisa A GrohskopfRobert L Atmar
Sep 12, 2019·American Journal of Epidemiology·Qifang BiJustin Lessler
Aug 25, 2018·MMWR. Recommendations and Reports : Morbidity and Mortality Weekly Report. Recommendations and Reports·Lisa A GrohskopfDaniel B Jernigan

❮ Previous
Next ❯

Related Concepts

Related Feeds

Birth Defects

Birth defects encompass structural and functional alterations that occur during embryonic or fetal development and are present since birth. The cause may be genetic, environmental or unknown and can result in physical and/or mental impairment. Here is the latest research on birth defects.

Related Papers

Clinical Obstetrics and Gynecology
Sonja A Rasmussen, Denise J Jamieson
The New England Journal of Medicine
Siri E HåbergCamilla Stoltenberg
Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America
Jennifer L RichardsSaad B Omer
© 2021 Meta ULC. All rights reserved