Status:
COMPLETED
Safety of Inhaled Zanamivir in Pregnancy
Lead Sponsor:
GlaxoSmithKline
Conditions:
Influenza, Human
Eligibility:
FEMALE
Brief Summary
Zanamivir is a neuraminidase inhibitor that has demonstrated effectiveness against the pandemic H1N1 virus. Zanamivir was first authorized in Sweden in June 1999 and is approved in the European Union ...
Eligibility Criteria
Inclusion
- Pregnacy Outcomes and Treatment Emergent Diagnoses Analysis Groups:
- Pregnant women who have received treatment or prophylaxis regimens of zanamivir or have not received these products
- Pregnancy completion occurring from December 2009 through November 2010
- Cogenital Anomalies Group:
- Live born infants of pregnant women included in the Pregnacy Outcomes and Treatment Emergent Diagnoses Analysis Groups
Exclusion
- Women who received amantadine or rimantadine at any time during pregnancy
Key Trial Info
Start Date :
July 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01462487
Start Date
July 1 2011
End Date
August 1 2012
Last Update
April 21 2014
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