Status: Finalised First registered on: 17/11/2010
Last updated on: 28/11/2013
1. Study identification
EU PAS Register NumberEUPAS1705
Official titleA/H1N1 pandemic vaccines and pregnancy outcomes
Study title acronym
Study typeObservational study
Brief description of the study1) identification of relevant research centres, organisations and agencies active in the evaluation and safety of A/H1N1 vaccine safety in pregnant women; 2) organise and coordinate an exchange of information between these centres, organisations and agencies with the aim to conduct a meta analysis of study results where appropriate; 3) In collaboration with all stakeholders, produce a proposal for a long-term collaboration between research centres active in the field of drugs and pregnancy outcomes, including interaction with ENCePP; this deliverable will involve extending the profile of centres included in the inventory mentioned under 1)
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)?
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 belongsUniversity of Bath
Department/Research group
Organisation/affiliation
Website/Homepage
Details of (Primary) lead investigator
Title Professor
Last name de Vries
First name Corinne
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?2

LSHTM
University of Bath
Countries in which this study is being conducted
International study

Denmark
Finland
Germany
Italy
Netherlands
Sweden
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed19/10/201019/10/2010
Start date of data collection19/10/201026/10/2010
Start date of data analysis30/11/2012
Date of interim report, if expected19/07/2011
Date of final study report30/06/201331/01/2013
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 body
Research councils
EU funding scheme
OtherEMA100
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name de Vries
First name Corinne
Address line 1Department of Pharmacy & Pharmacology
Address line 2University of Bath 
Address line 3Claverton Down 
CityBath 
PostcodeBA2 7AY 
CountryUnited Kingdom
Phone number (incl. country code)441225384228 
Alternative phone number 
Fax number (incl. country code) 
Email address c.de-vries@bath.ac.uk
Public Enquiries
Title Professor 
Last name de Vries 
First name Corinne 
Address line 1Department of Pharmacy & Pharmacology 
Address line 2University of Bath 
Address line 3Claverton Down 
CityBath 
PostcodeBA2 7AY 
CountryUnited Kingdom 
Phone number (incl. country code)441225384228 
Alternative phone number 
Fax number (incl. country code) 
Email address c.de-vries@bath.ac.uk 
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