COVID-19 Vaccine Adverse ReactionNCT05857176
Assessment of Safety and Satisfaction Toward COVID-19 Vaccines.
An observational study of COVID-19 Vaccine Adverse Reaction, run by Damanhour University at 1 site in Egypt.
Trial summary
This is a cross-sectional, web-based online survey done with the use of a Google Form-questionnaire to gather information from the general public regarding their knowledge, satisfaction, and tolerability about the COVID-19 vaccine. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- COVID-19 Vaccine Adverse Reaction
- What is being tested?
- COVID-19 Vaccine questionnaire
- Type of treatment
- Vaccines
- How many people
- 508 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2021to 10 Feb 2022
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The subjects participating in the study are residents in Egypt who complete the online questionnaire.
Who may be able to join
- all adults (age ≥ 18 years) complete the questionnaire were considered eligible to participate in the survey.
Who cannot join
- Incomplete questionnaires were excluded from the final analysis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Safety and Satisfaction Toward COVID-19 Vaccines: A Cross-sectional Study.
This is a cross-sectional, web-based online survey done with the use of a Google Form-questionnaire to gather information from the general public regarding their knowledge, satisfaction, and tolerability about the COVID-19 vaccine.
Read the detailed description
- A cross-sectional study was conducted. The subjects participating in the study are residents in Egypt.
- An online questionnaire, designed on Google Forms, was written in Arabic language and delivered to participants via social media (primarily Facebook, WhatsApp and Linkedin).
- The questionnaire comprised two categories of inquiries. The first is demographic data of the subject. The second is questions about COVID-19 vaccine-related data, such as whether had taken the vaccine or not, the type of vaccine administered, side effects encountered from the vaccine , if got enough information regarding the vaccine and where obtain the vaccine information from and if reluctant to taking the vaccine and the reasons for hesitancy. All participants were permitted to terminate the survey at any time of the study.
- Conditions
- COVID-19 Vaccine Adverse Reaction
- Being tested
- COVID-19 Vaccine questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 Vaccine questionnaireOther
Also called Google form questionnaire
An online questionnaire, designed on Google Forms, was written in Arabic language and delivered to participants via social media (primarily Facebook, WhatsApp and Linkedin).
What is being measured
The primary outcome is the main question the study is designed to answer.
headache incidence
Pecentage
Measured: 3 month
fever incidence
Pecentage
Measured: 3 month
fatigue incidence
Pecentage
Measured: 3 month
pain at site of injection incidence
Pecentage
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start15 Dec 2021
- Primary completion1 Feb 2022
- Study completion10 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 508 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damanhour University
- Sponsor type
- University, hospital or other
- Collaborators
- Alexandria University
- Responsible party
- Principal investigator, Rehab Werida, Damanhour University
- Investigators
- Rehab H Werida, Ass. Prof., Principal investigator, Damanhour University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05857176
- Sponsor's protocol ID
- COVID-19 vaccines Perception
- Status last verified
- May 2023
- First submitted
- 10 May 2023
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Malik A, Malik J, Ishaq U. Acceptance of COVID-19 vaccine in Pakistan among health care workers. PLoS One. 2021 Sep 15;16(9):e0257237. doi: 10.1371/journal.pone.0257237. eCollection 2021.
PubMed 34525110Lazarus JV, Ratzan SC, Palayew A, Gostin LO, Larson HJ, Rabin K, Kimball S, El-Mohandes A. A global survey of potential acceptance of a COVID-19 vaccine. Nat Med. 2021 Feb;27(2):225-228. doi: 10.1038/s41591-020-1124-9. Epub 2020 Oct 20.
PubMed 33082575
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Safety and Satisfaction Toward COVID-19 Vaccines: A Cross-sectional Study.
- ClinicalTrials.gov ID
- NCT05857176
- Acronym / sponsor ID
- COVID-19 vaccines Perception
- Conditions
- COVID-19 Vaccine Adverse Reaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 508 participants (actual)
- Lead sponsor
- Damanhour UniversityUniversity, hospital or other
- Collaborators
- Alexandria University
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 12 May 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.
This is a cross-sectional, web-based online survey done with the use of a Google Form-questionnaire to gather information from the general public regarding their knowledge, satisfaction, and tolerability about the COVID-19 vaccine.
Detailed description
- A cross-sectional study was conducted. The subjects participating in the study are residents in Egypt.
- An online questionnaire, designed on Google Forms, was written in Arabic language and delivered to participants via social media (primarily Facebook, WhatsApp and Linkedin).
- The questionnaire comprised two categories of inquiries. The first is demographic data of the subject. The second is questions about COVID-19 vaccine-related data, such as whether had taken the vaccine or not, the type of vaccine administered, side effects encountered from the vaccine , if got enough information regarding the vaccine and where obtain the vaccine information from and if reluctant to taking the vaccine and the reasons for hesitancy. All participants were permitted to terminate the survey at any time of the study.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subjects participating in the study are residents in Egypt who complete the online questionnaire.
Key inclusion criteria (1 listed)
- all adults (age ≥ 18 years) complete the questionnaire were considered eligible to participate in the survey.
Key exclusion criteria (1 listed)
- Incomplete questionnaires were excluded from the final analysis.
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 |
|---|---|---|
| COVID-19 Vaccine questionnaireAlso: Google form questionnaireAn online questionnaire, designed on Google Forms, was written in Arabic language and delivered to participants via social media (primarily Facebook, WhatsApp and Linkedin). | Other | – |
Primary outcome
headache incidence
Time frame: 3 month
Pecentage
fever incidence
Time frame: 3 month
Pecentage
fatigue incidence
Time frame: 3 month
Pecentage
pain at site of injection incidence
Time frame: 3 month
Pecentage
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 23 May 2023.
- Background: PubMed 34525110Malik A, Malik J, Ishaq U. Acceptance of COVID-19 vaccine in Pakistan among health care workers. PLoS One. 2021 Sep 15;16(9):e0257237. doi: 10.1371/journal.pone.0257237. eCollection 2021.
- Background: PubMed 33082575Lazarus JV, Ratzan SC, Palayew A, Gostin LO, Larson HJ, Rabin K, Kimball S, El-Mohandes A. A global survey of potential acceptance of a COVID-19 vaccine. Nat Med. 2021 Feb;27(2):225-228. doi: 10.1038/s41591-020-1124-9. Epub 2020 Oct 20.
- 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.
Rehab H Werida, Ass. Prof. principal investigator
Damanhour University
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 COVID-19 Vaccine Adverse Reaction, run by Damanhour University at 1 site in Egypt.
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 23 May 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 Egypt. 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?
headache incidence (time frame: 3 month). The study lists 4 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 NCT05857176, which also lists 2 linked publications.
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 23 May 2023.