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.