Study identification

EU PAS number

EUPAS5359

Study ID

16879

Official title and acronym

Safety of influenza AH1N1 pandemic vaccination during pregnancy: a comparative study using the EFEMERIS database

DARWIN EU® study

No

Study countries

France

Study description

Pregnant 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.

Study status

Finalised
Research institutions and networks

Institutions

Contact details

Christine Damase-Michel

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Data analysis start date

Actual:

Date of final study report

Actual:
Sources of funding
Other

More details on funding

Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM), CNAMTS, the Clinical Research Hospital Program
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable