- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Rodrigo DeAntonio, MD, DrPH
- Telefonnummer: +50762059692
- E-post: rodrigo.deantonio@endpoints.site
Studiesteder
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Provincia de Panamá
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Panama City, Provincia de Panamá, Panama
- CEVAXIN
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Ta kontakt med:
- Gabrielle Britton, PhD
- E-post: gabrielle.britton@cevaxin.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
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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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Level of knowledge, attitudes, and practices regarding PCV21 vaccination among adults aged 50 years and older in Panama
Tidsramme: 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.
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At enrollment / single study visit
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Ana G Lucas, MD, Endpoints
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- MISP 104141 (Annet stipend/finansieringsnummer: MSD)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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