Clinical trial NCT04845048: Active Pharmacovigilance Study of Adsorbed COVID-19 (Inactivated) Vaccine
Official title: Active Pharmacovigilance Study of Post-vaccine Adverse Events of Sinovac's/ Butantan Institute Adsorbed COVID-19 (Inactivated) Vaccine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV-2 Acute Respiratory Disease
Keywords: COVID-19
Adsorbed COVID-19 vaccine (inactivated)
Pharmacovigilance
Lead sponsor: Butantan Institute
Sponsor class: OTHER_GOV
First posted: 2021-04-14
Enrollment: 2549
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety of the Adsorbed COVID-19 (inactivated) Vaccine through the incidence of adverse reactions.
timeFrame: 7 days after each dose of the vaccine
measure: Safety of the Adsorbed COVID-19 (inactivated) Vaccine through the incidence of participants who presented adverse reactions according to the age group
timeFrame: 7 days after each dose of the vaccine
Secondary outcomes:
measure: Safety of the Adsorbed COVID-19 (inactivated) Vaccine through the incidence of adverse reactions which needed medical care in participants >= 18 years.
timeFrame: 42 days after any dose of the vaccine
measure: Safety of the Adsorbed COVID-19 (inactivated) Vaccine through the incidence of adverse reactions which required medical care in participants < 18 years.
timeFrame: 365 days after the second dose of the vaccine.
measure: Safety of the Adsorbed COVID-19 (inactivated) Vaccine through the incidence of adverse reactions.
timeFrame: First 30 minutes after each dose of the vaccine.
measure: Incidence of serious adverse event (AE)
timeFrame: The whole period of study (365 days after the second dose)
measure: Description of medications used after adverse event (AE)
timeFrame: The whole period of study (365 days after the second dose)
measure: Incidence of adverse event of special interest (AESI)
timeFrame: The whole period of study (365 days after the second dose)
measure: Incidence of serious adverse event if a subject get pregnant (SAE)
timeFrame: From the recrod of pregnancy until the end of the study or upto the birth.
Other outcomes:
Locations:
city: Botucatu
country: Brazil
facility: Centro de Saúde Escola da Faculdade de Medicina de Botucatu - Unesp.
state: São Paulo
city: Ribeirão Preto
country: Brazil
facility: Centro de Saúde Escola da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (HCFMRP-USP) Dr. Joel Domingos Machado.
state: São Paulo
city: São Paulo
country: Brazil
facility: Centro de Referência de Imunobiológicos Especiais. Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (CRIEHCFMUSP)
Study officials:
affiliation: University of Sao Paulo
name: Marta H Lopes, MD
role: PRINCIPAL_INVESTIGATOR
References: