- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07809113
PCV21 Acceptance in Adults ≥50 Years and Caregivers in Panama
Intergenerational Determinants of PCV21 Acceptance in Adults ≥50 Years in Panama: Knowledge, Attitudes, and Practices in Older Adults and Their Caregivers
This study will look at what adults age 50 years and older in Panama know, think, and do about pneumococcal vaccination, including the 21-valent pneumococcal conjugate vaccine (PCV21). Pneumococcal disease can cause pneumonia and other serious infections, and older adults may be at higher risk of severe illness. The study will help researchers understand what supports or prevents vaccine acceptance in this population.
The study will include two groups. Group A will include adults 50 to 64 years of age. Group B will include adults 65 years of age or older and a caregiver chosen by the older adult. A caregiver may be a family member or another person who regularly helps or supports the older adult. Researchers will study whether the caregiver's views about vaccines are related to the older adult's intention to receive PCV21.
Participants will complete a one-time survey about pneumococcal disease, vaccines, vaccination history, health information sources, trust in vaccines, barriers to vaccination, and factors that may make vaccination easier. Surveys may be completed on paper with help from study staff or digitally using a tablet or smartphone. The survey is expected to take about 10 to 15 minutes. For older adults and caregivers in Group B, each person will complete their own survey separately so that one person's answers do not influence the other's answers.
This is an observational study. No vaccine, medicine, or study product will be given as part of the study. Taking part involves answering survey questions only. The study will recruit participants from public and private health care facilities, including at least one rural or semi-urban site, to better reflect the diversity of adults in Panama.
The information from this study may help health care providers, public health teams, and community organizations design clearer and more useful communication about pneumococcal vaccination for adults and their caregivers. The results may also support future recommendations for adult vaccination programs in Panama and similar settings.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Rodrigo DeAntonio, MD, DrPH
- Phone Number: +50762059692
- Email: rodrigo.deantonio@endpoints.site
Study Locations
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Provincia de Panamá
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Panama City, Provincia de Panamá, Panama
- CEVAXIN
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Contact:
- Gabrielle Britton, PhD
- Email: gabrielle.britton@cevaxin.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria Older adults - all cohorts
- Age 50 years or older.
- Cohort A: 50-64 years.
- Cohort B: 65 years or older.
- Resident of Panama, including urban, semi-urban, or rural areas.
- Has access to medical care through the public or private health care system.
- Able and willing to provide signed informed consent.
Caregivers - Cohort B only
- Age 18 years or older.
- Identified as the caregiver of a Cohort B older adult.
- Has regular cohabitation or contact with the older adult, defined as at least once per week.
- Able and willing to provide signed informed consent.
Exclusion Criteria
Older adults - all cohorts
- Cognitive impairment that prevents the participant from providing informed consent.
- Does not speak Spanish and no interpreter is available.
Caregivers - Cohort B only
- Professional caregiver with no personal relationship to the older adult.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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COHORT A
Adults 50-64 years
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COHORT B
Adults ≥65 years + caregiver (dyads)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Level of knowledge, attitudes, and practices regarding PCV21 vaccination among adults aged 50 years and older in Panama
Time Frame: At enrollment / single study visit
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Knowledge, attitudes, and practices regarding pneumococcal disease and PCV21 vaccination will be assessed using a structured KAP survey.
Survey domains include knowledge of pneumococcal disease and available vaccines, attitudes toward vaccination and PCV21, vaccine confidence, perceived risk, prior vaccination practices, preventive care behaviors, and sources of health information.
Results will be summarized overall and by cohort.
|
At enrollment / single study visit
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ana G Lucas, MD, Endpoints
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MISP 104141 (Other Grant/Funding Number: MSD)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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