Study identification

EU PAS number

EUPAS1705

Study ID

5304

Official title and acronym

A/H1N1 pandemic vaccines and pregnancy outcomes

DARWIN EU® study

No

Study countries

Denmark
Finland
Germany
Italy
Netherlands
Sweden
United Kingdom

Study description

1) 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)

Study status

Finalised
Research institutions and networks

Institutions

Contact details

Corinne de Vries

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Actual:
Sources of funding
EMA
Regulatory

Was the study required by a regulatory body?

Yes