Status:
COMPLETED
Influenza Vaccine Effectiveness of a Quadrivalent Vaccine in Pregnant Women and Young Infants, 2019-2020
Lead Sponsor:
University of Athens
Collaborating Sponsors:
Hellenic Pasteur Institute
Conditions:
Influenza in Human
Eligibility:
FEMALE
18-45 years
Brief Summary
Influenza is associated with an increased risk for serious illness, hospitalization and death in pregnant women and young infants. The investigators estimated the effectiveness of a quadrivalent inact...
Detailed Description
Study period: Influenza 2019-2020 season The investigators followed actively the pregnant women and their infants in order to collect prospectively data on a weekly basis through phone calls during t...
Eligibility Criteria
Inclusion
- Pregnant women \>18 years old and \<45 years old, cared at Alexandra General Hospital (Athens, Greece) between October 16 and January 27, 2020
Exclusion
- \<18 years old or \>45 years old
- not in stable health
- already vaccinated against influenza
- history of Guillain-Barré syndrome
- history of hypersensitivity to influenza vaccines
- immunosuppression
- history of investigational drug \<30 days
- history of immunoglobulins or blood products \<3 months
- fever at day of interview (enrollment day)
Key Trial Info
Start Date :
September 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 31 2020
Estimated Enrollment :
949 Patients enrolled
Trial Details
Trial ID
NCT04723771
Start Date
September 1 2019
End Date
August 31 2020
Last Update
May 11 2021
Active Locations (1)
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1
First Department of Obstetrics and Gynecology, University of Athens
Athens, Attica, Greece