Vaccine RefusalNCT04618796
Effect of COVID-19 Pandemic on Vaccination Compliance
An observational study of Vaccine Refusal, run by Assiut University.
Trial summary
1- Evaluate the impact of the COVID-19 pandemic on pediatric vaccinations compliance among children attending to Assiut University Children Hospital ,assess the general health profile of studied children. Read more about this study
- Who is it for?
- Ages 1 year to 2 years
- Conditions the study is for
- Vaccine Refusal
- What is being tested?
- vaccine
- Type of treatment
- Vaccines
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to 1 May 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 1 year to 2 years
- All sexes
- Child
Study population: Children from 12 to 24 months
Who may be able to join
- Children from 12 to 24 months who admitted in Assiut University Children Hospital or attending the outpatient clinics
Who cannot join
- : Immunodeficiency (e.g chemotherapy, long term immunosuppressive therapy, hematologic tumor).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of COVID-19 Pandemic on Vaccination Compliance Among Children Attending Assiut University Children Hospital
1- Evaluate the impact of the COVID-19 pandemic on pediatric vaccinations compliance among children attending to Assiut University Children Hospital ,assess the general health profile of studied children.
Read the detailed description
Corona virus disease (COVID-19) is a disease caused by a new corona virus called Severe Acute Respiratory Syndrome Corona virus 2 (SARS-CoV-2). On March 11, the WHO Director-General declared COVID-19 a pandemic1. The first outbreak occurred in Wuhan, China. 2,3 COVID-19 pandemic has severely affected global health services.4 It is important not to overlook the value of some public health preventive interventions which cannot be postponed, such as vaccinations.5 As reported by WHO, the disruption of immunization services, even for brief periods, will result in increased numbers of susceptible individuals, raising the risks of an upsurge in outbreak-prone VPDs.6 The reduction of vaccination coverage could cause an increase in morbidity and mortality among children. Consequently, a greater burden could be placed on health systems. Examples from previous large epidemics (e.g. diphtheria in the former Soviet Union in 1990-1996 and in Venezuela in 2017-2018) show that, when vaccination coverage falls or vaccinations are disrupted, cases of infectious diseases that have disappeared can quickly re-emerge.7-8 Egypt declared a national state of emergency to control COVID-19 pandemic and implemented a stay-at-home order. Such strategies might result in decreased accessibility to routine immunization services, leaving children at risk for vaccine-preventable diseases and their complications.9 Great efforts are needed for rapid catch-up of children not up-to-date with routine vaccines. Parental concerns about potentially exposing their children to COVID-19 during vaccination visits might contribute to incompalince.10 Reminding parents of the vital need to protect their children against serious vaccine-preventable diseases is critical.
- Conditions
- Vaccine Refusal
- Being tested
- vaccine
- Keywords
- Covid19
- Medical subject headings
- Vaccination Refusal, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaccineOther
Effect of COVID-19 pandemic on vaccination compliance among children attending Assiut University Children Hospital and what is the degree of that.
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the vaccination coverage rate among the studied children after the COVID-19 pandemic
The investigators evaluate factors effect on compliance as covid-19, scioeconomic status, poverty, chronic disease and residance.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start1 Dec 2021 (estimated)
- Primary completion1 Apr 2022 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine RefusalStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gehad Gamal Ahmed, Assiut University
- Investigators
- Ismail lotfy, associated professor, Study director, Assiut UniversityMohamed Hamdy, professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04618796
- Sponsor's protocol ID
- Effect of COVID on vaccination
- Status last verified
- Jul 2021
- First submitted
- 2 Nov 2020
- Last updated
- 3 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of COVID-19 Pandemic on Vaccination Compliance Among Children Attending Assiut University Children Hospital
- ClinicalTrials.gov ID
- NCT04618796
- Acronym / sponsor ID
- Effect of COVID on vaccination
- Conditions
- Vaccine Refusal
- Keywords
- Covid19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 6 Nov 2020 (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.
1- Evaluate the impact of the COVID-19 pandemic on pediatric vaccinations compliance among children attending to Assiut University Children Hospital ,assess the general health profile of studied children.
Detailed description
Corona virus disease (COVID-19) is a disease caused by a new corona virus called Severe Acute Respiratory Syndrome Corona virus 2 (SARS-CoV-2). On March 11, the WHO Director-General declared COVID-19 a pandemic1. The first outbreak occurred in Wuhan, China. 2,3 COVID-19 pandemic has severely affected global health services.4 It is important not to overlook the value of some public health preventive interventions which cannot be postponed, such as vaccinations.5 As reported by WHO, the disruption of immunization services, even for brief periods, will result in increased numbers of susceptible individuals, raising the risks of an upsurge in outbreak-prone VPDs.6 The reduction of vaccination coverage could cause an increase in morbidity and mortality among children. Consequently, a greater burden could be placed on health systems. Examples from previous large epidemics (e.g. diphtheria in the former Soviet Union in 1990-1996 and in Venezuela in 2017-2018) show that, when vaccination coverage falls or vaccinations are disrupted, cases of infectious diseases that have disappeared can quickly re-emerge.7-8 Egypt declared a national state of emergency to control COVID-19 pandemic and implemented a stay-at-home order. Such strategies might result in decreased accessibility to routine immunization services, leaving children at risk for vaccine-preventable diseases and their complications.9 Great efforts are needed for rapid catch-up of children not up-to-date with routine vaccines. Parental concerns about potentially exposing their children to COVID-19 during vaccination visits might contribute to incompalince.10 Reminding parents of the vital need to protect their children against serious vaccine-preventable diseases is critical.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 year to 2 years
- Sex
- All
- Age groups
- Child
- Study population
- Children from 12 to 24 months
Key inclusion criteria (1 listed)
- Children from 12 to 24 months who admitted in Assiut University Children Hospital or attending the outpatient clinics
Key exclusion criteria (1 listed)
- : Immunodeficiency (e.g chemotherapy, long term immunosuppressive therapy, hematologic tumor).
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 |
|---|---|---|
| vaccineEffect of COVID-19 pandemic on vaccination compliance among children attending Assiut University Children Hospital and what is the degree of that. | Other | – |
Primary outcome
Measure the vaccination coverage rate among the studied children after the COVID-19 pandemic
Time frame: Baseline
The investigators evaluate factors effect on compliance as covid-19, scioeconomic status, poverty, chronic disease and residance.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- Effect of COVID-19 pandemic on vaccination compliance among children attending Assiut University Children HospitalLink provided by the sponsor.
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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.
Ismail lotfy, associated professor study director
Assiut University
Mohamed Hamdy, professor study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Vaccine Refusal, run by Assiut University.
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: status not confirmed, as of the sponsor's last update on 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gehad Gamal, resident doctor (01006011751, gehadgamal098@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the vaccination coverage rate among the studied children after the COVID-19 pandemic (time frame: Baseline). 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 3 Aug 2021.