Influenza Vaccine Effectiveness of a Quadrivalent Vaccine in Pregnant Women and Young Infants, 2019-2020

Influenza in Human Clinical Trial

Official title:

Influenza Vaccination Effectiveness of a Quadrivalent Inactivated Vaccine in Pregnant Women and Young Infants (Aged 6 Months and Below) During Influenza Season 2019/2020

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04723771
• Other study ID #: 16708
• Status: Completed
• 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
• 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)

Related Conditions & MeSH terms

• Influenza in Human
• Influenza, Human

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