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NCT Number: NCT04723771

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

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.

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Key information

Conditions

Influenza in Human Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

First Department of Obstetrics and Gynecology, University of Athens

Athens, Attica, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. rates of laboratory-confirmed influenza in vaccinated and unvaccinated pregnant women

    Time frame: 2019-2020 influenza season

    influenza vaccine effectiveness against laboratory-confirmed influenza in pregnant women

  2. rates of laboratory-confirmed influenza in young infants whose mothers were vaccinated and in infants of unvaccinated mothers

    Time frame: 2019-2020 influenza season

    influenza vaccine effectiveness against laboratory-corfirmed influenza in young infants

Secondary outcomes

  1. 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

    Time frame: 2019-2020 influenza season

    influenza vaccine effectiveness against the abovementioned secondary outcomes

Sponsors and collaborators

Lead sponsor

University of Athens

Other

Collaborators

  • Hellenic Pasteur Institute

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 26, 2021
Registry last updated
May 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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