NCT05735769

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,797

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2021

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 17, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
Last Updated

February 22, 2023

Status Verified

February 1, 2023

Enrollment Period

7 months

First QC Date

February 17, 2023

Last Update Submit

February 20, 2023

Conditions

Vaccine Adverse ReactionGenderCOVID-19 Vaccine Adverse Reaction

Outcome Measures

Primary Outcomes (1)

  • 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

    5 months

Secondary Outcomes (1)

  • Severity score post-vaccine anti-COVID-19

    5 months

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Random sample from the Italian and Lebanese population who received first or first and second dose of anti-COVID-19 vaccine

You may qualify if:

  • Anti-COVID-19 vaccine

You may not qualify if:

  • Subjects who living outside Italy or Lebanon

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Biomedical Sciences and Human Oncology - Clinica medica "A. Murri"

Bari, BA, 70124, Italy

Location

MeSH Terms

Conditions

Coitus

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD

Study Record Dates

First Submitted

February 17, 2023

First Posted

February 21, 2023

Study Start

January 1, 2021

Primary Completion

July 30, 2021

Study Completion

September 15, 2021

Last Updated

February 22, 2023

Record last verified: 2023-02

Locations

IT(1)