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

NCT ID: NCT04723771

Last Updated: 2021-05-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 949 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2020-08-31

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.

Detailed 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.

Conditions

Influenza in Human

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hellenic Pasteur Institute

UNKNOWN

Sponsor Role: collaborator

University of Athens

OTHER

Sponsor Role: lead

Responsible Party

Helena Maltezou

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dimitrios Loutradis, Professor

Role: PRINCIPAL_INVESTIGATOR

First Department of Obstetrics and Gynecology, University of Athens

Locations

First Department of Obstetrics and Gynecology, University of Athens

Athens, Attica, Greece

Countries

Greece

References

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.

Reference Type: DERIVED

PMID: 34878959 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

16708

Identifier Type: -

Identifier Source: org_study_id