Influenza in HumanNCT04723771
Influenza Vaccine Effectiveness of a Quadrivalent Vaccine in Pregnant Women and Young Infants, 2019-2020
An observational study of Influenza in Human, run by University of Athens at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Influenza in Human
- How many people
- 949 participants
- Where
- 1 siteGreece
- Study dates
- 1 Sep 2019to 31 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women and their infants
Who may be able to join
- Pregnant women >18 years old and <45 years old, cared at Alexandra General Hospital (Athens, Greece) between October 16 and January 27, 2020
Who cannot join
- <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
Show all 9Show fewer
- history of investigational drug <30 days
- history of immunoglobulins or blood products <3 months
- fever at day of interview (enrollment day)
Trial locations and contacts
1 site in 1 country.
Greece1 site
First Department of Obstetrics and Gynecology, University of Athens
Athens, Attica
About this study
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
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.
Read the 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
- Keywords
- influenza, quadrivalent influenza vaccine, influenza vaccine effectiveness, pregnancy, pregnant women, infants
- Medical subject headings
- Influenza, Human
What is being measured
The primary outcome is the main question the study is designed to answer.
rates of laboratory-confirmed influenza in vaccinated and unvaccinated pregnant women
influenza vaccine effectiveness against laboratory-confirmed influenza in pregnant women
Measured: 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
Measured: 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
influenza vaccine effectiveness against the abovementioned secondary outcomes
Measured: 2019-2020 influenza season
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start1 Sep 2019
- Primary completion30 Apr 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Influenza in HumanStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 949 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Collaborators
- Hellenic Pasteur Institute
- Responsible party
- Principal investigator, Helena Maltezou, University of Athens
- Investigators
- Dimitrios Loutradis, Professor, Principal investigator, First Department of Obstetrics and Gynecology, University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04723771
- Sponsor's protocol ID
- 16708
- Status last verified
- May 2021
- First submitted
- 22 Sep 2020
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: In order to share IPD we should request permission from the Ethics Committee of the hospital.
Publications
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.
PubMed 34878959
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04723771
- Acronym / sponsor ID
- 16708
- Conditions
- Influenza in Human
- Keywords
- influenza, quadrivalent influenza vaccine, influenza vaccine effectiveness, pregnancy, pregnant women, infants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 949 participants (actual)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Collaborators
- Hellenic Pasteur Institute
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 26 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women and their infants
Key inclusion criteria (1 listed)
- Pregnant women >18 years old and <45 years old, cared at Alexandra General Hospital (Athens, Greece) between October 16 and January 27, 2020
Key exclusion criteria (9 listed)
- <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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- Derived from this study: PubMed 34878959Maltezou 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.
- Individual participant dataSharing planned: Undecided. In order to share IPD we should request permission from the Ethics Committee of the hospital.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dimitrios Loutradis, Professor principal investigator
First Department of Obstetrics and Gynecology, University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza in Human, run by University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rates of laboratory-confirmed influenza in vaccinated and unvaccinated pregnant women (time frame: 2019-2020 influenza season). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04723771, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2021.