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Adverse Reactions Following COVID-19 Vaccination Among Ecuadorian Healthcare Workers

NCT ID: NCT05113472

Last Updated: 2021-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1291 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-01

Study Completion Date

2021-05-31

Brief Summary

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Limited large-scale studies have been conducted to investigate the adverse effects of COVID-19 vaccine in Latin America, particularly among the healthcare worker (HCW) population in Ecuador. The objective of this study was to assess a cohort of Ecuadorian healthcare workers for adverse reactions following vaccination with the Pfizer-BioNTech vaccine.

Detailed Description

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The COVID-19 pandemic bears a burden on medical care and economies worldwide, however immunization at the population level provides a way for to reduce future morbidity and mortality. Vaccine hesitancy and reluctance in getting the COVID-19 vaccine and apprehensions about them have been present along the course of vaccination programs and mass immunizations across the world. Factors such as the quick, large-scale production of vaccines, lack of information, and uncertainty about adverse reactions in the public's eye as well about myths spreading through media channels have given rise to suspicion and fear in the Latin American population. Limited large-scale studies have been conducted to investigate the adverse effects of COVID-19 vaccine in Latin America, particularly among the healthcare worker (HCW) population in Ecuador. The objective of this study was to assess a cohort of Ecuadorian healthcare workers for adverse reactions following vaccination with the Pfizer-BioNTech vaccine.

Conditions

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Adverse Drug Event

Keywords

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adverse reactions COVID-19 healthcare workers Latin America vaccination

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Ecuadorian Healthcare Workers

All individuals involved were part of the first phase of the national COVID-19 vaccination plan in our country and were contacted through a local registry established by a local private university.

Pfizer-BioNTech COVID-19 vaccine

Intervention Type BIOLOGICAL

Patients who were administered any dose of the Pfizer-BioNTech COVID-19 vaccine.

Interventions

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Pfizer-BioNTech COVID-19 vaccine

Patients who were administered any dose of the Pfizer-BioNTech COVID-19 vaccine.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Ecuadorian nationality
* Active practice in the medical field
* Received the Pfizer-BioNTech COVID-19 vaccine

Exclusion Criteria

* Patients who voluntarily refused to participate.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Respiralab

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Universidad Espiritu Santo

Samborondón, , Ecuador

Site Status

Countries

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Ecuador

Other Identifiers

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2021-MED-001

Identifier Type: -

Identifier Source: org_study_id