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

SARS-CoV-2 Acute Respiratory Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04845048
• Other study ID #: CFV-01-IB
• Secondary ID: Instituto Butant
• Status: Completed
• Start date: May 10, 2021
• Est. completion date: March 13, 2023

Study information

• Verified date: May 2023
• Source: Butantan Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2549
• Est. completion date: March 13, 2023
• Est. primary completion date: March 12, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Respiration Disorders
• Respiratory Tract Diseases
• SARS-CoV-2 Acute Respiratory Disease

Intervention

Biological:
• Adsorbed COVID-19 (Inactivated) Vaccine
Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac/Butantan Institute

Locations

Country	Name	City	State
Brazil	Centro de Saúde Escola da Faculdade de Medicina de Botucatu - Unesp.	Botucatu	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.	Ribeirão Preto	São Paulo
Brazil	Centro de Referência de Imunobiológicos Especiais. Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (CRIEHCFMUSP)	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Butantan Institute

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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.
Secondary	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.
Secondary	Incidence of serious adverse event (AE)	Incidence of serious adverse event	The whole period of study (365 days after the second dose)
Secondary	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)
Secondary	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)
Secondary	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.