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

NCT04723771 | Completed

• 1 other identifier: 16708
• Study Type: observational
• Target: 949
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Influenza in Human

Keywords

influenza; quadrivalent influenza vaccine; influenza vaccine effectiveness; pregnancy; pregnant women; infants

Outcome Measures

Primary Outcomes (2)

• 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

• 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 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

  2019-2020 influenza season

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women and their infants

You may qualify if:

• Pregnant women \>18 years old and \<45 years old, cared at Alexandra General Hospital (Athens, Greece) between October 16 and January 27, 2020

You may not qualify if:

• \<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)

Sponsors & Collaborators

• University of Athens: lead
• Hellenic Pasteur Institute: collaborator

Study Sites (1)

First Department of Obstetrics and Gynecology, University of Athens

Athens, Attica, Greece

Location

Related Publications (1)

• Maltezou HC, Stavros S, Asimakopoulos G, Pergialiotis V, Raftopoulos V, Talias MA, Pavli A, Daskalakis G, Sindos M, Koutroumanis P, Theodora M, Antsaklis P, Kostis E, Stratiki E, Kossyvakis A, Theodoridou M, Mentis A, Drakakis P, Loutradis D, Rodolakis A. Effectiveness of maternal vaccination with quadrivalent inactivated influenza vaccine in pregnant women and their infants in 2019-2020. Expert Rev Vaccines. 2022 Jul;21(7):983-992. doi: 10.1080/14760584.2022.2013820. Epub 2022 Jan 24.

  PMID: 34878959 DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Dimitrios Loutradis, Professor

  First Department of Obstetrics and Gynecology, University of Athens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: January 26, 2021
• Study Start: September 1, 2019
• Primary Completion: April 30, 2020
• Study Completion: August 31, 2020
• Last Updated: May 11, 2021

Record last verified: 2021-05

Locations

GR (1)