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

Active Pharmacovigilance Study of Post-vaccine Adverse Events of Sinovac's/ Butantan Institute Adsorbed COVID-19 (Inactivated) Vaccine

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.

Study Overview

• Status: Completed
• Conditions: SARS-CoV-2 Acute Respiratory Disease
• Intervention / Treatment: Biological: Adsorbed COVID-19 (Inactivated) Vaccine

Detailed Description

. 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.

• The immunization schedule is two doses intramuscular injections (deltoid) with a 14-28 days interval.
• There will be 900 participants (300 health care professionals between 18 and 59 years old); 300 participants 75 years old or more; 300 participants between 60 and 74 years old. All participants must be allowed to receive the Adsorbed COVID-19 (inactivated) Vaccine according to the Brazilian Immunization National Plan.
• For safety analysis , the incidence of adverse events after receiving the Adsorbed COVID-19 (inactivated) Vaccine that needed health assistance until 42 days after two-doses immunization schedule.
• The total period of participation in the study will be approximately 60 days after completing the two-dose schedule of the vaccine.
• Active pharmacovigilance studies are essential to assess the safety profile of the vaccine in subgroups that will be included as target populations in the Immunization Program.

• Study Type: Observational
• Enrollment (Actual): 2549

Contacts and Locations

• Study Contact: Name: Alexander R Precioso, MD, PhD; Phone Number: +55 11 3723-2150; Email: alexander.precioso@butantan.gov.br

Study Locations

• Brazil
  • São Paulo, Brazil
    • Centro de Referência de Imunobiológicos Especiais. Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (CRIEHCFMUSP)
    • Contact: Marta Heloísa Lopes, MD, PhD
  • São Paulo
    • Botucatu, São Paulo, Brazil
      • Centro de Saúde Escola da Faculdade de Medicina de Botucatu - Unesp.
      • Contact: Paulo José F Villas Boas, MD, PhD
    • Ribeirão Preto, São Paulo, Brazil
      • Centro de Saúde Escola da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (HCFMRP-USP) Dr. Joel Domingos Machado.
      • Contact: Anderson S da Silva, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Health care professionals between 18 and 59 years old; Health care professionals	Biological: Adsorbed COVID-19 (Inactivated) Vaccine; Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac/Butantan Institute
General population 75 years old or more; Elderly 75y plus	Biological: Adsorbed COVID-19 (Inactivated) Vaccine; Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac/Butantan Institute
General population 60 and 74 years old; Elderly between 60-74y	Biological: Adsorbed COVID-19 (Inactivated) Vaccine; Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac/Butantan Institute

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of the Adsorbed COVID-19 (inactivated) Vaccine through the incidence of adverse reactions which needed medical care in participants >= 18 years.	Frequency of solicited and non-solicited local and systemic adverse reactions, which required medical care according to the dose and severity.	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.	Frequency of solicited and non-solicited local and systemic adverse reactions, which required medical care according to the dose and severity.	365 days after the second dose of the vaccine.
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 the dose, severity and age group.	First 30 minutes after each dose of the vaccine.
Incidence of serious adverse event (AE)	Incidence of serious adverse event	The whole period of study (365 days after the second dose)
Description of medications used after adverse event (AE)	Description of medications and duration used after adverse event	The whole period of study (365 days after the second dose)
Incidence of adverse event of special interest (AESI)	Incidence of adverse event of special interest	The whole period of study (365 days after the second dose)
Incidence of serious adverse event if a subject get pregnant (SAE)	Incidence of serious adverse event if a subject get pregnant after received any dose of the vaccine	From the recrod of pregnancy until the end of the study or upto the birth.

Collaborators and Investigators

• Sponsor: Butantan Institute
• Investigators: Principal Investigator: Marta H Lopes, MD, University of Sao Paulo

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2021
• Primary Completion (Actual): March 12, 2023
• Study Completion (Actual): March 13, 2023

Study Registration Dates

• First Submitted: April 12, 2021
• First Submitted That Met QC Criteria: April 12, 2021
• First Posted (Actual): April 14, 2021

Study Record Updates

• Last Update Posted (Actual): May 22, 2023
• Last Update Submitted That Met QC Criteria: May 19, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: COVID-19; Pharmacovigilance; Adsorbed COVID-19 vaccine (inactivated)
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: CFV-01-IB; Instituto Butantan (Other Identifier: Fundação Butantan)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No