Monitoring the Effectiveness and Safety of COVID-19 Vaccines at National University of Colombia

NCT04887246 | Completed

• 1 other identifier: 52932
• Study Type: observational
• Target: 4,078
• Locations: 1 country
• Sites: 1

Brief Summary

There are relevant questions that need to be answered about the effectiveness and safety of COVID-19 vaccines. The objective of this observational study is to follow up the clinical outcomes after vaccination in all the headquarters of the National University of Colombia. It is a project that is considered institutional importance and is part of the actions that the National University of Colombia has proposed to the national government to accompany the national vaccination program. The proposed follow-up includes the sociodemographic, cultural, clinical and pharmacological characterization of the vaccinated population, including the report of adverse events occurring after the vaccination process, the behavior of the population after the administration of the vaccine, monitoring serological outcomes, identification of medication errors and therapeutic failure. Three stages are proposed in which the population affiliated to UNISALUD is gradually included, then the beneficiaries and later the student community and their families. The scope of the attached protocol includes Stage I, which corresponds to teachers and administrative staff (active and retired) linked to UNISALUD.

Conditions

Covid19; SARS-CoV2 Infection

Keywords

Covid-19; Vaccines; Safety and Effectiveness

Outcome Measures

Primary Outcomes (2)

• Adverse events

  Reports of Adverse Events Associated with COVID-19 Vaccines

  One year

• COVID-19 diagnosis

  People who after the vaccination process are diagnosed with COVID-19

  One year

Secondary Outcomes (1)

• Serological response

  One year

Study Arms (1)

UNISALUD population

Refers to all affiliated members or beneficiaries of the UNISALUD entity, who got any of tthe COVID-19 vaccines available in Colombia

Biological: COVID-19 vaccines

Interventions

COVID-19 vaccines BIOLOGICAL

COVID-19 vaccines available at Colombia

UNISALUD population

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The cohort of the university population (UNISALUD affiliated and beneficiary personnel, students and their families),

You may qualify if:

• All UN contractors (administrative, teachers and pensioners) who belong to the different UN headquarters and agree to participate in the study

You may not qualify if:

• Contractors not not affiliated to UNISALUD

Sponsors & Collaborators

• Universidad Nacional de Colombia: lead

Study Sites (1)

Universidad Nacional de Colombia

Bogotá, Colombia

Location

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: May 14, 2021
• Study Start: March 15, 2021
• Primary Completion: April 15, 2022
• Study Completion: December 15, 2022
• Last Updated: July 11, 2024

Record last verified: 2024-07

Locations

CO (1)