Immunization; InfectionNCT05661890
Seasonal Influenza and Pneumococcal Vaccination in the Elderly
An observational study of Immunization; Infection and Influenza, run by Lokman Hekim University at 1 site in Turkey (Türkiye).
Trial summary
The elderly population and individuals with chronic diseases are at high risk for influenza and influenza-related pneumonia, and it is emphasized that taking pneumonia and influenza vaccine together is effective in reducing mortality as well as hospitalization rates and costs due to pneumonia, influenza, and… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Immunization; Infection, Influenza, Pneumonia
- How many people
- 1,166 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2022to 15 Feb 2023
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: The population is individuals over the age of 65 living in the central district of Ankara. The sample size required for the study and its distribution by neighborhoods were calculated according to the WHO LKT modüle. The minimum required sample size was calculated as 972, by accepting the preliminary decision that 75 lots would be used in the study, and p=35%, 95% confidence interval, and deviation value of ±3 in the study. However, the minimum sample size for the number of elderly per LOT was accepted as 15 and the number was increased by 20% considering possible data losses and the sample size was accepted as 1166. The region of each lot was determined on the map, and sample selection was made using random methods in the study.
Who may be able to join
- -Over the age of 65.
Who cannot join
- Cancer diagnosis
- Having a disease that will require immunosuppressive treatment
- Transplantation cases
- Rheumatoid arthritis
- Systemic lupus erythematosus
- Inflammatory bowel disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Lokman Hekim University
Ankara, Çankaya, 06510
About this study
Official title: Prevalence of Seasonal Influenza and Pneumococcal Vaccination and Determinants of Vaccination in the Elderly: Nested Case-Control Study
The elderly population and individuals with chronic diseases are at high risk for influenza and influenza-related pneumonia, and it is emphasized that taking pneumonia and influenza vaccine together is effective in reducing mortality as well as hospitalization rates and costs due to pneumonia, influenza, and congestive heart disease.
This study that will be carried out will enable to determine the population-based prevalence of the relevant vaccines in the elderly and to determine the determinants of vaccination with the case group to be determined based on this.
Read more
The aim of the study is two phases.
- Determination of the prevalence of seasonal influenza and pneumococcal vaccination in elderly people over the over the age of 65 living in Ankara.
- Investigation of socioeconomic characteristics and vaccine indecision and some health-related determinants of vaccination through the case group created based on the preliminary study on the prevalence of seasonal influenza and pneumococcal vaccination in the elderly over the age of 65 living in Ankara.
The study, which includes cross-sectional prevalence and retrospective case-control stages, is planned to be carried out with individuals over the age of 65 living in Ankara province between November 1 and December 31, 2022.
Read the detailed description
The elderly population and individuals with chronic diseases are at high risk for influenza and influenza-related pneumonia, and it is emphasized that taking pneumonia and influenza vaccine together is effective in reducing mortality as well as hospitalization rates and costs due to pneumonia, influenza, and congestive heart disease.
In recent years, progress has been made in vaccination as a result of the increase in health-seeking behavior due to the pandemic, the greater importance of influenza and pneumococcal vaccine application recommendations, and the perception of the prevention of lung infections due to COVID-19.
However, the discussions on the need to predict vaccine demand and examine health behaviors, health education, and research on new methods of vaccination efficacy in reducing future epidemics continue to be relevant.
This study that will be carried out will enable to determine the population-based prevalence of the relevant vaccines in the elderly and to determine the determinants of vaccination with the case group to be determined based on this.
Research questions-Prevalence
- What is the prevalence of influenza vaccination in the elderly?
- What is the prevalence of pneumonia vaccination in the elderly?
Research Questions - Case Control
- Are socio-economic characteristics (region of residence, monthly income, education, perceived economic status) effective in vaccinating the elderly?
- Are health-related features (chronic illness, drug use, previous vaccination status, priority preference in health care, frequency of hospitalization and hospitalization in the last six months, distance from health institution, self-defense behavior) effective in vaccinating the elderly?
- Is the vaccination attitude effective in vaccinating the elderly?
- Conditions
- Immunization; Infection, Influenza, Pneumonia, Vaccine Refusal
- Keywords
- Vaccine, Influenza, Pneumonia, Elderly
- Medical subject headings
- Infections, Influenza, Human, Pneumonia, Vaccination Refusal
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Influenza Vaccination uptake
The number of self reported influenza vaccine uptake
Measured: During 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start15 Nov 2022
- Primary completion30 Jan 2023
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunization; InfectionStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lokman Hekim University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Belgin Akın, Lokman Hekim University
- Investigators
- Belgin Akın, Principal investigator, Lokman Hekim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05661890
- Sponsor's protocol ID
- LokmanHekimU-SBF-HB-BA-01
- Status last verified
- Feb 2023
- First submitted
- 14 Dec 2022
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Seasonal Influenza and Pneumococcal Vaccination and Determinants of Vaccination in the Elderly: Nested Case-Control Study
- ClinicalTrials.gov ID
- NCT05661890
- Acronym / sponsor ID
- LokmanHekimU-SBF-HB-BA-01
- Conditions
- Immunization; Infection, Influenza, Pneumonia, Vaccine Refusal
- Keywords
- Vaccine, Influenza, Pneumonia, Elderly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,166 participants (actual)
- Lead sponsor
- Lokman Hekim UniversityOther government
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 22 Dec 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.
The elderly population and individuals with chronic diseases are at high risk for influenza and influenza-related pneumonia, and it is emphasized that taking pneumonia and influenza vaccine together is effective in reducing mortality as well as hospitalization rates and costs due to pneumonia, influenza, and congestive heart disease.
This study that will be carried out will enable to determine the population-based prevalence of the relevant vaccines in the elderly and to determine the determinants of vaccination with the case group to be determined based on this.
The aim of the study is two phases.
- Determination of the prevalence of seasonal influenza and pneumococcal vaccination in elderly people over the over the age of 65 living in Ankara.
- Investigation of socioeconomic characteristics and vaccine indecision and some health-related determinants of vaccination through the case group created based on the preliminary study on the prevalence of seasonal influenza and pneumococcal vaccination in the elderly over the age of 65 living in Ankara.
The study, which includes cross-sectional prevalence and retrospective case-control stages, is planned to be carried out with individuals over the age of 65 living in Ankara province between November 1 and December 31, 2022.
Detailed description
The elderly population and individuals with chronic diseases are at high risk for influenza and influenza-related pneumonia, and it is emphasized that taking pneumonia and influenza vaccine together is effective in reducing mortality as well as hospitalization rates and costs due to pneumonia, influenza, and congestive heart disease.
In recent years, progress has been made in vaccination as a result of the increase in health-seeking behavior due to the pandemic, the greater importance of influenza and pneumococcal vaccine application recommendations, and the perception of the prevention of lung infections due to COVID-19.
However, the discussions on the need to predict vaccine demand and examine health behaviors, health education, and research on new methods of vaccination efficacy in reducing future epidemics continue to be relevant.
This study that will be carried out will enable to determine the population-based prevalence of the relevant vaccines in the elderly and to determine the determinants of vaccination with the case group to be determined based on this.
Research questions-Prevalence
- What is the prevalence of influenza vaccination in the elderly?
- What is the prevalence of pneumonia vaccination in the elderly?
Research Questions - Case Control
- Are socio-economic characteristics (region of residence, monthly income, education, perceived economic status) effective in vaccinating the elderly?
- Are health-related features (chronic illness, drug use, previous vaccination status, priority preference in health care, frequency of hospitalization and hospitalization in the last six months, distance from health institution, self-defense behavior) effective in vaccinating the elderly?
- Is the vaccination attitude effective in vaccinating the elderly?
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The population is individuals over the age of 65 living in the central district of Ankara. The sample size required for the study and its distribution by neighborhoods were calculated according to the WHO LKT modüle. The minimum required sample size was calculated as 972, by accepting the preliminary decision that 75 lots would be used in the study, and p=35%, 95% confidence interval, and deviation value of ±3 in the study. However, the minimum sample size for the number of elderly per LOT was accepted as 15 and the number was increased by 20% considering possible data losses and the sample size was accepted as 1166. The region of each lot was determined on the map, and sample selection was made using random methods in the study.
Key inclusion criteria (1 listed)
- -Over the age of 65.
Key exclusion criteria (6 listed)
- Cancer diagnosis
- Having a disease that will require immunosuppressive treatment
- Transplantation cases
- Rheumatoid arthritis
- Systemic lupus erythematosus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Influenza Vaccination uptake
Time frame: During 2022
The number of self reported influenza vaccine uptake
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 24 Feb 2023.
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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.
Belgin Akın principal investigator
Lokman Hekim 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 Immunization; Infection and Influenza, run by Lokman Hekim University at 1 site in Turkey (Türkiye).
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 6 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 24 Feb 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 Turkey (Türkiye). 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?
Number of Influenza Vaccination uptake (time frame: During 2022). 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 24 Feb 2023.