Vaccine Adverse ReactionVAX-IT-LEBNCT05735769
Anti-COVID-19 Vaccine Side Effects
An observational study of Vaccine Adverse Reaction and Gender, run by University of Bari at 1 site in Italy.
Trial summary
In 2021 and following the COVID-19 (corona virus disease 2019) pandemic, different vaccines were initially authorized in Italy and Lebanon. Notably, vaccine side effects were poorly recorded. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaccine Adverse Reaction, Gender, COVID-19 Vaccine Adverse Reaction
- How many people
- 2,797 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2021to 15 Sep 2021
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Random sample from the Italian and Lebanese population who received first or first and second dose of anti-COVID-19 vaccine
Who may be able to join
- Anti-COVID-19 vaccine
Who cannot join
- Subjects who living outside Italy or Lebanon
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Biomedical Sciences and Human Oncology - Clinica medica "A. Murri"
Bari, BA, 70124
About this study
Official title: Gender-dependent Symptoms Following Anti-COVID-19 Vaccine in a Lebanese and Italian Populations
In 2021 and following the COVID-19 (corona virus disease 2019) pandemic, different vaccines were initially authorized in Italy and Lebanon. Notably, vaccine side effects were poorly recorded. Thus, the investigator performed a survey study to monitor COVID-19 vaccine side effects among Italian and Lebanese citizens according to gender and age through a web-based questionnaire in Italian and Arabic languages including 21 items by "Google Form", investigating 13 symptoms, and employing social-media platforms
Read the detailed description
The COVID-19 pandemic has presented a real challenge to the public health system worldwide since the year 2019, spreading to more than 200 countries and regions worldwide.The emergence and rapid spread of COVID-19 were caused by the coronavirus SARS-CoV-2. Worldwide, the use of COVID-19 vaccines was initially authorized for emergency use and the side effects were not stated clearly. Common side effects were expected but specific side effects linked with COVID-19 vaccines remained uncertain. In this context, survey studies are needed for a comprehensive evaluation of the relationships between vaccine administration, related undesired effects and vaccine safety.
This study represents the first survey following early COVID-19 vaccines administration in two geographic areas, comparatively considering possible differences due to gender and age. A web-based survey was conducted on a cohort of 1975 Italian and 822 Lebanese people who received at least one dose of COVID-19 vaccine. The study was conducted between March and July 2021 on a voluntary basis, and by a tailored anonymous web-based questionnaire. The protocol was approved by the local Ethics Committee, University of Bari 'Aldo Moro' (study number 6752, protocol number 0031044). A specific questionnaire was designed in English and translated into Italian and Arabic. It contains 21 items including demographic data, the history of vaccine administration before COVID-19, the administration of the first and second dose of COVID-19 vaccine, and possible adverse effects.
The survey link was shared by a "Google Form" employing social-media platforms or by personal interview.
The questionnaire explored the presence of 13 possible symptoms appearing following the administration of the first and second dose of COVID-19 vaccine: pain at the injection site, redness at the injection site, swelling at the injection site, induration at the injection site, allergic-urticarial reaction, anaphylaxis, fever (>37 °C), diarrhea, vomiting, asthenia/fatigue, muscle pain, rash, sleepiness/insomnia, irritability/nervousness, headache, lymphadenopathy. The presence and intensity of symptoms were assessed semi-quantitatively by a Visual Analogue Scale (VAS). Besides symptoms, the following aspects were also evaluated: need of drug intake, consultation of a doctor, emergency admission to hospital, and possible hospitalization.
- Medical subject headings
- Coitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms post anti-COVID-19 vaccine
The questionnaire explored the presence of 13 possible symptoms appearing following the administration of the first and second dose of COVID-19 vaccine: pain at the injection site, redness at the injection site, swelling at the injection site, induration at the injection site, allergic-urticarial reaction, anaphylaxis, fever (>37 °C), diarrhea, vomiting, asthenia/fatigue, muscle pain, rash, sleepiness/insomnia, irritability/nervousness, headache, and lymphadenopathy
Measured: 5 months
Secondary outcomes (1)
Severity score post-vaccine anti-COVID-19
The severity score of symptoms was calculated as follows: [∑ (symptom * duration in hrs * intensity in VAS (visual analog score)] + use of antipyretic drugs (1point) + use of other analgesic drugs (1 point) + recourse to a doctor (1 point) + recourse to emergency room without admission to the ward (1 point) + admission to hospital ward (1 point). The range of the severity score was from 0 to 216 after first dose or second dose
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start1 Jan 2021
- Primary completion30 Jul 2021
- Study completion15 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine Adverse ReactionStudies 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
- Retrospective
- Enrolment
- 2,797 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bari
- Sponsor type
- University, hospital or other
- Collaborators
- Lebanese University
- Responsible party
- Principal investigator, piero portincasa, University of Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05735769
- Sponsor's protocol ID
- VaxITLB-19 2021
- Acronym
- VAX-IT-LEB
- Status last verified
- Feb 2023
- First submitted
- 17 Feb 2023
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gender-dependent Symptoms Following Anti-COVID-19 Vaccine in a Lebanese and Italian Populations
- ClinicalTrials.gov ID
- NCT05735769
- Acronym / sponsor ID
- VAX-IT-LEB / VaxITLB-19 2021
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,797 participants (actual)
- Lead sponsor
- University of BariUniversity, hospital or other
- Collaborators
- Lebanese University
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 21 Feb 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.
In 2021 and following the COVID-19 (corona virus disease 2019) pandemic, different vaccines were initially authorized in Italy and Lebanon. Notably, vaccine side effects were poorly recorded. Thus, the investigator performed a survey study to monitor COVID-19 vaccine side effects among Italian and Lebanese citizens according to gender and age through a web-based questionnaire in Italian and Arabic languages including 21 items by "Google Form", investigating 13 symptoms, and employing social-media platforms
Detailed description
The COVID-19 pandemic has presented a real challenge to the public health system worldwide since the year 2019, spreading to more than 200 countries and regions worldwide.The emergence and rapid spread of COVID-19 were caused by the coronavirus SARS-CoV-2. Worldwide, the use of COVID-19 vaccines was initially authorized for emergency use and the side effects were not stated clearly. Common side effects were expected but specific side effects linked with COVID-19 vaccines remained uncertain. In this context, survey studies are needed for a comprehensive evaluation of the relationships between vaccine administration, related undesired effects and vaccine safety.
This study represents the first survey following early COVID-19 vaccines administration in two geographic areas, comparatively considering possible differences due to gender and age. A web-based survey was conducted on a cohort of 1975 Italian and 822 Lebanese people who received at least one dose of COVID-19 vaccine. The study was conducted between March and July 2021 on a voluntary basis, and by a tailored anonymous web-based questionnaire. The protocol was approved by the local Ethics Committee, University of Bari 'Aldo Moro' (study number 6752, protocol number 0031044). A specific questionnaire was designed in English and translated into Italian and Arabic. It contains 21 items including demographic data, the history of vaccine administration before COVID-19, the administration of the first and second dose of COVID-19 vaccine, and possible adverse effects.
The survey link was shared by a "Google Form" employing social-media platforms or by personal interview.
The questionnaire explored the presence of 13 possible symptoms appearing following the administration of the first and second dose of COVID-19 vaccine: pain at the injection site, redness at the injection site, swelling at the injection site, induration at the injection site, allergic-urticarial reaction, anaphylaxis, fever (>37 °C), diarrhea, vomiting, asthenia/fatigue, muscle pain, rash, sleepiness/insomnia, irritability/nervousness, headache, lymphadenopathy. The presence and intensity of symptoms were assessed semi-quantitatively by a Visual Analogue Scale (VAS). Besides symptoms, the following aspects were also evaluated: need of drug intake, consultation of a doctor, emergency admission to hospital, and possible hospitalization.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Random sample from the Italian and Lebanese population who received first or first and second dose of anti-COVID-19 vaccine
Key inclusion criteria (1 listed)
- Anti-COVID-19 vaccine
Key exclusion criteria (1 listed)
- Subjects who living outside Italy or Lebanon
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
Symptoms post anti-COVID-19 vaccine
Time frame: 5 months
The questionnaire explored the presence of 13 possible symptoms appearing following the administration of the first and second dose of COVID-19 vaccine: pain at the injection site, redness at the injection site, swelling at the injection site, induration at the injection site, allergic-urticarial reaction, anaphylaxis, fever (>37 °C), diarrhea, vomiting, asthenia/fatigue, muscle pain, rash, sleepiness/insomnia, irritability/nervousness, headache, and lymphadenopathy
1 secondary outcome
Severity score post-vaccine anti-COVID-19
Time frame: 5 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 22 Feb 2023.
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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 Vaccine Adverse Reaction and Gender, run by University of Bari 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 22 Feb 2023. 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?
Symptoms post anti-COVID-19 vaccine (time frame: 5 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 22 Feb 2023.