Status: Finalised First registered on: 05/12/2013
Last updated on: 20/12/2016
1. Study identification
EU PAS Register NumberEUPAS5359
Official titleSafety of influenza AH1N1 pandemic vaccination during pregnancy: a comparative study using the EFEMERIS database
Study title acronym
Study typeObservational study
Brief description of the studyPregnant women are at increased risk of severe disease and death due to influenza infection. During the influenza AH1N1 pandemic in 2009–2010, recommendations in France were to vaccinate pregnant women during the second and third trimester preferably with a non-adjuvant vaccine. However, few data are available concerning this drug in pregnant women. The aim of the study was to compare birth outcomes between exposed and unexposed women to influenza AH1N1 vaccine during pregnancy. This observational cohort study compared 2 groups of exposed and unexposed pregnant women in EFEMERIS. EFEMERIS is a database including prescribed and dispensed reimbursed drugs during pregnancy (data from Caisse Primaire d'Assurance Maladie of Haute-Garonne) and outcomes (data from Maternal and Infant Protection Service and from Antenatal diagnosis Centre). Women who delivered from October 21th 2009 to November 30th 2010 in Haute-Garonne and were registered in the French Health Insurance Service have been included.
Was this study requested by a regulator?Yes: France
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsPharmacoepidemiology INSERM 1027
Department/Research groupPharmacoepidemiology research team
Organisation/affiliationUniversity of Toulouse 3 and INSERM 1027
Website/Homepagehttp://www.u1027.inserm.fr/
Details of (Primary) lead investigator
Title Dr
Last name Damase-Michel
First name Christine
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

France
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/04/2012
Start date of data collection01/05/2012
Start date of data analysis01/05/2012
Date of interim report, if expected
Date of final study report01/06/2013
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government bodyAgence Nationale de Sécurité du Médicament et des produits de santé (ANSM), CNAMTS, the Clinical Research Hospital Program100
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Damase-Michel
First name Christine
Address line 137 Allees Jules Guesde
Address line 2Faculté de médecine, Service de pharmacologie clinique 
Address line 3 
CityToulouse 
Postcode31000 
CountryFrance
Phone number (incl. country code)33-561145904 
Alternative phone number 
Fax number (incl. country code) 
Email address christine.damase-michel@univ-tlse3.fr
Public Enquiries
Title Dr 
Last name Damase-Michel 
First name Christine 
Address line 137 Allees Jules Guesde 
Address line 2Faculté de médecine, Service de pharmacologie clinique 
Address line 3 
CityToulouse 
Postcode31000 
CountryFrance 
Phone number (incl. country code)33-561145904 
Alternative phone number 
Fax number (incl. country code) 
Email address christine.damase-michel@univ-tlse3.fr 
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