Active Pharmacovigilance Study of Adsorbed COVID-19 (Inactivated) Vaccine

NCT04845048 | Completed

• 2 other identifiers: CFV-01-IBInstituto Butantan
• Study Type: observational
• Target: 2,549
• Locations: 1 country
• Sites: 3

Brief Summary

This is a prospective cohort study, observational, multicentre, single-arm, post-registration to assess the safety of the Adsorbed COVID-19 (Inactivated) Vaccine Sinovac / Institute Butantan.

Conditions

SARS-CoV-2 Acute Respiratory Disease

Keywords

COVID-19; Adsorbed COVID-19 vaccine (inactivated); Pharmacovigilance

Outcome Measures

Primary Outcomes (2)

• Safety of the Adsorbed COVID-19 (inactivated) Vaccine through the incidence of adverse reactions.

  Frequency of solicited and non-solicited local and systemic adverse reactions according to age group and severity.

  7 days after each dose of the vaccine

• Safety of the Adsorbed COVID-19 (inactivated) Vaccine through the incidence of participants who presented adverse reactions according to the age group

  Frequency of participants who presented any solicited and non-solicited local and systemic adverse reactions according to age group and severity.

  7 days after each dose of the vaccine

Secondary Outcomes (7)

• Safety of the Adsorbed COVID-19 (inactivated) Vaccine through the incidence of adverse reactions which needed medical care in participants >= 18 years.

  42 days after any dose of the vaccine

• Safety of the Adsorbed COVID-19 (inactivated) Vaccine through the incidence of adverse reactions which required medical care in participants < 18 years.

  365 days after the second dose of the vaccine.

• Safety of the Adsorbed COVID-19 (inactivated) Vaccine through the incidence of adverse reactions.

  First 30 minutes after each dose of the vaccine.

• Incidence of serious adverse event (AE)

  The whole period of study (365 days after the second dose)

• Description of medications used after adverse event (AE)

  The whole period of study (365 days after the second dose)

Study Arms (3)

Health care professionals between 18 and 59 years old

Health care professionals

Biological: Adsorbed COVID-19 (Inactivated) Vaccine

General population 75 years old or more

Elderly 75y plus

Biological: Adsorbed COVID-19 (Inactivated) Vaccine

General population 60 and 74 years old

Elderly between 60-74y

Biological: Adsorbed COVID-19 (Inactivated) Vaccine

Interventions

Adsorbed COVID-19 (Inactivated) Vaccine BIOLOGICAL

Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac/Butantan Institute

General population 60 and 74 years old; General population 75 years old or more; Health care professionals between 18 and 59 years old

Eligibility Criteria

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

Study Population

The population groups included in this study are the categories that have indication of immunization, defined by the national vaccination plan for COVID-19: health care professionals between 18 and 59 years old and elderly participants 60 aged or over

You may qualify if:

• Adult allowed to receive the Adsorbed COVID-19 (inactivated) Vaccine according to the Immunization National Plan.
• Informed consent form signed by participant.
• Show voluntary intention to participate in the study and availability throughout the study.

You may not qualify if:

• History of severe allergic reactions or anaphylaxis to previous vaccines or allergy to any components of the study vaccine.
• History of fever (axillar temperature ≥ 37,8º C) 72 hours before the vaccine
• Be unavailable during the study period.
• Any other condition that, in the opinion of the principal investigator or his/her representative physician, could put the safety/rights of potential participants at risk or prevent them from complying with this protocol.

Sponsors & Collaborators

• Butantan Institute: lead

Study Sites (3)

Centro de Saúde Escola da Faculdade de Medicina de Botucatu - Unesp.

Botucatu, São Paulo, Brazil

Location

Centro de Saúde Escola da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (HCFMRP-USP) Dr. Joel Domingos Machado.

Ribeirão Preto, São Paulo, Brazil

Location

Centro de Referência de Imunobiológicos Especiais. Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (CRIEHCFMUSP)

São Paulo, Brazil

Location

MeSH Terms

Conditions

COVID-19

Interventions

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)

Biological Products; Complex Mixtures

Study Officials

• Marta H Lopes, MD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 14, 2021
• Study Start: May 10, 2021
• Primary Completion: March 12, 2023
• Study Completion: March 13, 2023
• Last Updated: May 22, 2023

Record last verified: 2023-05

Locations

BR (3)