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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04723771
Other study ID # 16708
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2019
Est. completion date August 31, 2020

Study information

Verified date May 2021
Source University of Athens
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 inactivated influenza vaccine (QIV) in pregnant women and their infants in 2019-2020 influenza season. Women were activelly followed during the influenza season on a weekly basis through telephone call in order to collect data about the onset of fever and/or respiratory symptoms by them or their young infants. Polymerase chain reaction testing in pharyngeal samples was offered to pregnant women and infants with influenza-like illness (ILI). A total of 636 pregnant women and 474 infants were studied. A Bayesian beta-binomial model was used.


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 the entire influenza season. Definitions: - ILI was defined as the sudden onset of symptoms and fever, malaise, myalgia or headache, and cough, sore throat or shortness of breath. - ARI was defined as the presence of at least one respiratory symptom, regardless of fever. - Febrile episode was defined as the presence of fever only. - Fever was defined as a temperature of 38.0 C in at least two measurements within 24h. - The diagnoses of pneumonia and AOM were accepted as reported by the physicians who provided care to the women or their infants. The 2019-2020 QIV Vaxigrip-Tetra was used to vaccinate pregnant women.


Recruitment information / eligibility

Status Completed
Enrollment 949
Est. completion date August 31, 2020
Est. primary completion date April 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: Pregnant women >18 years old and <45 years old, cared at Alexandra General Hospital (Athens, Greece) between October 16 and January 27, 2020 Exclusion Criteria: - <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)

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Greece First Department of Obstetrics and Gynecology, University of Athens Athens Attica

Sponsors (2)

Lead Sponsor Collaborator
University of Athens Hellenic Pasteur Institute

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description Time frame Safety issue
Primary rates of laboratory-confirmed influenza in vaccinated and unvaccinated pregnant women influenza vaccine effectiveness against laboratory-confirmed influenza in pregnant women 2019-2020 influenza season
Primary rates of laboratory-confirmed influenza in young infants whose mothers were vaccinated and in infants of unvaccinated mothers influenza vaccine effectiveness against laboratory-corfirmed influenza in young infants 2019-2020 influenza season
Secondary rates of acute respiratory infection, influenza-like illness, febrile episode, use of antibiotics, use of antivirals, pneumonia, acute otitis media (for infants only), healthcare seeking and hospitalization in pregnant women and their infants influenza vaccine effectiveness against the abovementioned secondary outcomes 2019-2020 influenza season
See also
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Completed NCT02988739 - Comparison of Laser Assisted Epidermal to Intradermal Administration of Seasonal Influenza Vaccine Phase 1