COVID-19 VaccinesWORLDCOVNCT05471635
Variables Influencing Anti-COVID-19 Vaccinations Around the World: an Analysis Conducted on Aggregated Data Sourced From Institutional Databases to Understand Whether and How Different Variables Could Affect the Vaccine Coverage (WORLDCOV: Worldwide Determinants of COVID-19 Vaccination)
An observational study of COVID-19 Vaccines, run by Alberto Peano at 1 site in Italy.
Trial summary
Vaccination coverage against COVID-19 differs widely between countries: in order to address this public health issue, this observational study seeks to understand whether there are any determinants/predictors. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Vaccines
- What is being tested?
- COVID-19 Vaccine
- Type of treatment
- Vaccines
- How many people
- 205 participants
- Where
- 1 siteItaly
- Study dates
- 20 Jun 2022to 20 Jul 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All countries worldwide, if not excluded in reason of Exclusion Criteria
Who may be able to join
- All countries (independent or not) in the world
Who cannot join
- No data available on vaccination coverage and dose administered population ratio
- Substantial lack of data
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of Turin
Turin, 10126
Alberto Peano, Dr., +39 3923983663, alberto.peano@unito.it
About this study
Official title: Determinants of COVID-19 Vaccination Worldwide: WORLDCOV, a Retrospective Observational Study
Vaccination coverage against COVID-19 differs widely between countries: in order to address this public health issue, this observational study seeks to understand whether there are any determinants/predictors. In order to highlight the presence of determinants and their strength in influencing vaccination coverage, all possible socio-demographic, economic, cultural, infrastructural and political variables considered capable of modifying such coverage were selected and analysed.
Read the detailed description
The COVID-19 pandemic has had major health, economic and social implications, bringing with it a large number of deaths worldwide. While the lethality rate could not be considered high, the fact that the contagiousness was high resulted in a considerable number of deaths. As a result, the COVID-19 pandemic has become a sudden, huge and urgent public health problem.
Initially faced with a new and unknown etiopathological entity, different countries adopted different policies that proved more or less effective in containing the COVID-19 contagion. While social and hygienic restrictive measures (i.e. so-called social distancing, curfews, use of masks and hand hygiene) initially had a positive impact on reducing infections, for the most part they proved to be ephemeral measures. These actions were short-lived because they were not sustainable over time due to the damage they implied with regard to mental health, besides the low adherence of the population. A relaxation of these restrictive measures has always led to an increase in the spread of the COVID-19 pandemic, with a resurgence of hospital admissions, an ever-increasing occupancy of intensive care beds and a subsequent increase in the number of deaths.
Since the beginning of the COVID-19 pandemic, scientific research has been working to enable the identification of the SARS-CoV-2 viral genome and possible target proteins for treatment. Due to years of vaccine research and the launch of Access to COVID-19 Tools (ACT)-Accelerator partnership, a rapid development of several candidate vaccines based on different vaccine technologies and thus to their rapid clinical testing were possible.
Thanks also to the regulatory agencies' solicitude, in certain Countries (e.g. Israel, the UK, the US and the EU) the COVID-19 vaccination campaign started at the end of 2020 and extended worldwide during 2021 (with the exception of Eritrea and the Democratic Republic of Korea).
Through purchasing agreements with individual vaccine manufacturers, governments (or supranational institutions, e.g. the EU) secured the supply of the necessary doses. However, this entailed a division of the world's population depending on the negotiating power of the country of residence and, therefore, its economic strength. COVAX is one of the three pillars of the ACT-Accelerator programme: dedicated to vaccines, the purpose of COVAX is to accelerate the development and manufacture of COVID-19 vaccines, ensuring fair and equitable access for every country in the world.
In a globalised world, guaranteeing everyone the right to health is mandatory from a moral as well as an economic and global health point of view: everyone gains if the poorest improve their condition (think infectious diseases). In a globalised world, it is necessary to 'globalise' health and not only the economy: this study aims to understand where governments, supranational institutions and non-governmental organisations can act more incisively to combat the COVID-19 pandemic with the weapon the vaccine represents.
On this basis, the investigators decided to examine whether certain variables could be determinants of vaccination coverage for COVID-19. Two outcomes were identified as indicators of vaccination coverage: the proportion of the population vaccinated with at least one dose and the ratio of administered doses to the population. These data were obtained from the COVID-19 dataset by Our World In Data as of 15th June for each country. If data was not available on that date, the most recent available data was used looking retrospectively. In order to analyze whether and which were determinants of vaccination coverage, several variables are accounted: socio-demographic variables: total population, population density, median age, GINI Index; economic variables: GDP per capita; health variables: COVID-19-specific mortality, type of health system (public or private), health personnel (Physicians /1000 population, Nurses and midwives personnel/1000 population); cultural variables (literacy rate, Greenberg Index, presence of a predominant religion), infrastructural variables (density of road network, access to electricity) and political variables (civil liberties, political stability and absence of violence/terrorism). Data for the aforementioned variables were extracted from institutional databases/ datasets: World Bank, Our World In Data, World Religion Database and The World Factbook. For Greenberg Index, as proxy of Cultural Diversity Index, the data were from Gören (2018), taking the 2020 figure for each country, or the most recent available figure if the 2020 figure is not available.
Statistical analyses will be conducted including all countries in the world taken individually, for which vaccination data are available as of 15 June 2022. In addition, analyses will also be conducted for outcomes adjusted for vaccine doses delivered (in each country). The data for this correction factor were obtained from the UNICEF database on 21th June 2022.
Statistical analyses by subgroups will also be implemented, stratifying by World Bank country classification by income level: High, Upper-middle, Lower-middle, Low.
- Conditions
- COVID-19 Vaccines
- Being tested
- COVID-19 Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 VaccineBiological
All COVID-19 vaccines approved by national or international regulatory agency, despite the vaccine technology, manufacturer, and regulatory agency that granted marketing authorization.
| Study group | Role | What they receive |
|---|---|---|
| Countries worldwide | Every country in the world for which vaccination data were available and variables of interest were accessible. Receives: Biological: COVID-19 Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccination coverage
Proportion of the population vaccinated with at least one dose
Measured: 15th June 2022 for each country, independently from the beginning date of the COVID-19 vaccination campaign
Total doses administered per 100 residents
Doses of vaccine administered per 100 population in each country, that is the ratio of administered doses to the population
Measured: 15th June 2022 for each country, independently from the beginning date of the COVID-19 vaccination campaign
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start20 Jun 2022
- Primary completion20 Jul 2022 (estimated)
- Study completion20 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19 VaccinesStudies 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
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 205 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alberto Peano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alberto Peano, University of Turin, Italy
- Investigators
- Maria M Gianino, Prof., Study director, University of Turin, Department of Public Health Sciences and PediatricsAlberto Peano, Dr., Principal investigator, Department of Public Health Sciences and Pediatrics, University of TurinGianfranco Politano, PhD, Principal investigator, Department of Control and Computer Engineering, Polytechnic University of Turin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05471635
- Sponsor's protocol ID
- GP0012022
- Acronym
- WORLDCOV
- Status last verified
- Jul 2022
- First submitted
- 20 Jul 2022
- Last updated
- 27 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Peano A, Politano G, Gianino MM. Determinants of COVID-19 vaccination worldwide: WORLDCOV, a retrospective observational study. Front Public Health. 2023 Aug 31;11:1128612. doi: 10.3389/fpubh.2023.1128612. eCollection 2023.
PubMed 37719735
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of COVID-19 Vaccination Worldwide: WORLDCOV, a Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT05471635
- Acronym / sponsor ID
- WORLDCOV / GP0012022
- Conditions
- COVID-19 Vaccines
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 205 participants (estimated)
- Lead sponsor
- Alberto PeanoUniversity, hospital or other
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 20 Jul 2022 (estimated)
- Study completion
- 20 Jul 2022 (estimated)
- First posted
- 25 Jul 2022 (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.
Vaccination coverage against COVID-19 differs widely between countries: in order to address this public health issue, this observational study seeks to understand whether there are any determinants/predictors. In order to highlight the presence of determinants and their strength in influencing vaccination coverage, all possible socio-demographic, economic, cultural, infrastructural and political variables considered capable of modifying such coverage were selected and analysed.
Detailed description
The COVID-19 pandemic has had major health, economic and social implications, bringing with it a large number of deaths worldwide. While the lethality rate could not be considered high, the fact that the contagiousness was high resulted in a considerable number of deaths. As a result, the COVID-19 pandemic has become a sudden, huge and urgent public health problem.
Initially faced with a new and unknown etiopathological entity, different countries adopted different policies that proved more or less effective in containing the COVID-19 contagion. While social and hygienic restrictive measures (i.e. so-called social distancing, curfews, use of masks and hand hygiene) initially had a positive impact on reducing infections, for the most part they proved to be ephemeral measures. These actions were short-lived because they were not sustainable over time due to the damage they implied with regard to mental health, besides the low adherence of the population. A relaxation of these restrictive measures has always led to an increase in the spread of the COVID-19 pandemic, with a resurgence of hospital admissions, an ever-increasing occupancy of intensive care beds and a subsequent increase in the number of deaths.
Since the beginning of the COVID-19 pandemic, scientific research has been working to enable the identification of the SARS-CoV-2 viral genome and possible target proteins for treatment. Due to years of vaccine research and the launch of Access to COVID-19 Tools (ACT)-Accelerator partnership, a rapid development of several candidate vaccines based on different vaccine technologies and thus to their rapid clinical testing were possible.
Thanks also to the regulatory agencies' solicitude, in certain Countries (e.g. Israel, the UK, the US and the EU) the COVID-19 vaccination campaign started at the end of 2020 and extended worldwide during 2021 (with the exception of Eritrea and the Democratic Republic of Korea).
Through purchasing agreements with individual vaccine manufacturers, governments (or supranational institutions, e.g. the EU) secured the supply of the necessary doses. However, this entailed a division of the world's population depending on the negotiating power of the country of residence and, therefore, its economic strength. COVAX is one of the three pillars of the ACT-Accelerator programme: dedicated to vaccines, the purpose of COVAX is to accelerate the development and manufacture of COVID-19 vaccines, ensuring fair and equitable access for every country in the world.
In a globalised world, guaranteeing everyone the right to health is mandatory from a moral as well as an economic and global health point of view: everyone gains if the poorest improve their condition (think infectious diseases). In a globalised world, it is necessary to 'globalise' health and not only the economy: this study aims to understand where governments, supranational institutions and non-governmental organisations can act more incisively to combat the COVID-19 pandemic with the weapon the vaccine represents.
On this basis, the investigators decided to examine whether certain variables could be determinants of vaccination coverage for COVID-19. Two outcomes were identified as indicators of vaccination coverage: the proportion of the population vaccinated with at least one dose and the ratio of administered doses to the population. These data were obtained from the COVID-19 dataset by Our World In Data as of 15th June for each country. If data was not available on that date, the most recent available data was used looking retrospectively. In order to analyze whether and which were determinants of vaccination coverage, several variables are accounted: socio-demographic variables: total population, population density, median age, GINI Index; economic variables: GDP per capita; health variables: COVID-19-specific mortality, type of health system (public or private), health personnel (Physicians /1000 population, Nurses and midwives personnel/1000 population); cultural variables (literacy rate, Greenberg Index, presence of a predominant religion), infrastructural variables (density of road network, access to electricity) and political variables (civil liberties, political stability and absence of violence/terrorism). Data for the aforementioned variables were extracted from institutional databases/ datasets: World Bank, Our World In Data, World Religion Database and The World Factbook. For Greenberg Index, as proxy of Cultural Diversity Index, the data were from Gören (2018), taking the 2020 figure for each country, or the most recent available figure if the 2020 figure is not available.
Statistical analyses will be conducted including all countries in the world taken individually, for which vaccination data are available as of 15 June 2022. In addition, analyses will also be conducted for outcomes adjusted for vaccine doses delivered (in each country). The data for this correction factor were obtained from the UNICEF database on 21th June 2022.
Statistical analyses by subgroups will also be implemented, stratifying by World Bank country classification by income level: High, Upper-middle, Lower-middle, Low.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Countries worldwide | – | Biological: COVID-19 VaccineEvery country in the world for which vaccination data were available and variables of interest were accessible. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All countries worldwide, if not excluded in reason of Exclusion Criteria
Key inclusion criteria (1 listed)
- All countries (independent or not) in the world
Key exclusion criteria (2 listed)
- No data available on vaccination coverage and dose administered population ratio
- Substantial lack of data
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 VaccineAll COVID-19 vaccines approved by national or international regulatory agency, despite the vaccine technology, manufacturer, and regulatory agency that granted marketing authorization. | Biological | Countries worldwide |
Primary outcome
Vaccination coverage
Time frame: 15th June 2022 for each country, independently from the beginning date of the COVID-19 vaccination campaign
Proportion of the population vaccinated with at least one dose
Total doses administered per 100 residents
Time frame: 15th June 2022 for each country, independently from the beginning date of the COVID-19 vaccination campaign
Doses of vaccine administered per 100 population in each country, that is the ratio of administered doses to the population
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Derived from this study: PubMed 37719735Peano A, Politano G, Gianino MM. Determinants of COVID-19 vaccination worldwide: WORLDCOV, a retrospective observational study. Front Public Health. 2023 Aug 31;11:1128612. doi: 10.3389/fpubh.2023.1128612. eCollection 2023.
- Individual participant dataSharing planned: Undecided
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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.
Maria M Gianino, Prof. study director
University of Turin, Department of Public Health Sciences and Pediatrics
Alberto Peano, Dr. principal investigator
Department of Public Health Sciences and Pediatrics, University of Turin
Gianfranco Politano, PhD principal investigator
Department of Control and Computer Engineering, Polytechnic University of Turin
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 Vaccines, run by Alberto Peano 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 2 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 27 Jul 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alberto Peano, Dr. (+39 3923983663, alberto.peano@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaccination coverage (time frame: 15th June 2022 for each country, independently from the beginning date of the COVID-19 vaccination campaign). The study lists 2 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 NCT05471635, which also lists 1 linked publication.
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 27 Jul 2022.