Influenza VaccinationNCT05785078
Evaluation of a Flu Vaccination Program Directed at Pregnant Women Assisted at a Research Hospital in Italy.
An observational study of Influenza Vaccination, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Influenza is a serious Public Health problem, which causes a high number of cases and deaths worldwide each year. In Italy, about 8 million cases were reported in the 2018/2019 flu season, 809 of which were severe, with 198 deaths. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Influenza Vaccination
- What is being tested?
- Educational session about vaccinations
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- How many people
- 119 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2019to 31 Jan 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Pregnant women and their partners attending the childbirth preparatory course held at Fondazione Policlinico Universitario "A. Gemelli" IRRCS
Who may be able to join
- Attendance to the educational session about vaccination in the context of the childbirth preparatory course held at Fondazione Policlinico Universitario "A. Gemelli" IRRCS
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario "A. Gemelli" IRCCS
Rome, RM, 00168
About this study
Official title: Evaluation of the Impact of a Program to Raise Awareness About Flu Vaccination and a Vaccination Campaign Aimed at Women Participating in the Childbirth Preparation Course Held at Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Influenza is a serious Public Health problem, which causes a high number of cases and deaths worldwide each year. In Italy, about 8 million cases were reported in the 2018/2019 flu season, 809 of which were severe, with 198 deaths. Pregnant women are considered one of the most at-risk groups, as infection can lead to serious complications for the mother and fetus. The Italian Ministry of Health recommends free flu vaccination for pregnant women in the second or third trimester, as the vaccine is safe and effective in protecting the mother, fetus and newborn.
During the 2018-2019 flu season, the Fondazione Policlinico Universitario A. Gemelli IRCCS (FPG) held an educational session on maternal and childhood vaccinations in the context of the Childbirth Preparation Course held monthly at the FPG, offering the on-site flu vaccination to participants and their partners, if present.
The objectives of this study are: to improve knowledge and attitudes regarding vaccination in the course participants, assessing their changes through a pre-post anonymous questionnaire; to evaluate the impact of the flu vaccination strategy implemented, through the analysis of vaccination coverage.
- Conditions
- Influenza Vaccination
- Being tested
- Educational session about vaccinations
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational session about vaccinationsBehavioural
An educational session about maternal and childhood vaccinations was held in the context of the Childbirth Preparation Course held monthly at the FPG. In this occasion, on-site flu vaccination was offered to pregnant women attending the course and their partners, if present.
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in knowledge and attitudes regarding vaccination
Change in Knowledge and Attitudes About Vaccination from Pre- to Post-Educational Session
Measured: 4 months
Secondary outcomes (1)
Vaccination compliance
Number of Participants Compliant with On-site Influenza Vaccination Offer
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start1 Oct 2019
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza VaccinationStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- 119 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laurenti Patrizia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05785078
- Sponsor's protocol ID
- 2782
- Status last verified
- Aug 2025
- First submitted
- 14 Mar 2023
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of a Program to Raise Awareness About Flu Vaccination and a Vaccination Campaign Aimed at Women Participating in the Childbirth Preparation Course Held at Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- ClinicalTrials.gov ID
- NCT05785078
- Acronym / sponsor ID
- 2782
- Conditions
- Influenza Vaccination
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 27 Mar 2023 (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 a serious Public Health problem, which causes a high number of cases and deaths worldwide each year. In Italy, about 8 million cases were reported in the 2018/2019 flu season, 809 of which were severe, with 198 deaths. Pregnant women are considered one of the most at-risk groups, as infection can lead to serious complications for the mother and fetus. The Italian Ministry of Health recommends free flu vaccination for pregnant women in the second or third trimester, as the vaccine is safe and effective in protecting the mother, fetus and newborn.
During the 2018-2019 flu season, the Fondazione Policlinico Universitario A. Gemelli IRCCS (FPG) held an educational session on maternal and childhood vaccinations in the context of the Childbirth Preparation Course held monthly at the FPG, offering the on-site flu vaccination to participants and their partners, if present.
The objectives of this study are: to improve knowledge and attitudes regarding vaccination in the course participants, assessing their changes through a pre-post anonymous questionnaire; to evaluate the impact of the flu vaccination strategy implemented, through the analysis of vaccination coverage.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women and their partners attending the childbirth preparatory course held at Fondazione Policlinico Universitario "A. Gemelli" IRRCS
Key inclusion criteria (1 listed)
- Attendance to the educational session about vaccination in the context of the childbirth preparatory course held at Fondazione Policlinico Universitario "A. Gemelli" IRRCS
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational session about vaccinationsAn educational session about maternal and childhood vaccinations was held in the context of the Childbirth Preparation Course held monthly at the FPG. In this occasion, on-site flu vaccination was offered to pregnant women attending the course and their partners, if present. | Behavioural | – |
Primary outcome
Differences in knowledge and attitudes regarding vaccination
Time frame: 4 months
Change in Knowledge and Attitudes About Vaccination from Pre- to Post-Educational Session
1 secondary outcome
Vaccination compliance
Time frame: 4 months
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 14 Aug 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Vaccination, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 1 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 14 Aug 2025. 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 Italy. 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?
Differences in knowledge and attitudes regarding vaccination (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2025.