Anti-COVID-19 Vaccine Side Effects

Vaccine Adverse Reaction Clinical Trial

— VAX-IT-LEB  

Official title:

Gender-dependent Symptoms Following Anti-COVID-19 Vaccine in a Lebanese and Italian Populations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05735769
• Other study ID #: VaxITLB-19 2021
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: September 15, 2021

Study information

• Verified date: February 2023
• Source: University of Bari
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2797
• Est. completion date: September 15, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Anti-COVID-19 vaccine

Exclusion Criteria:

• Subjects who living outside Italy or Lebanon

Related Conditions & MeSH terms

• COVID-19
• Gender
• Vaccine Adverse Reaction

Locations

Country	Name	City	State
Italy	Department of Biomedical Sciences and Human Oncology - Clinica medica "A. Murri"	Bari	BA

Sponsors (2)

Lead Sponsor	Collaborator
University of Bari	Lebanese University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	5 months