Active Pharmacovigilance Study of Adsorbed COVID-19 (Inactivated) Vaccine
- Conditions
- SARS-CoV-2 Acute Respiratory Disease
- Interventions
- Biological: Adsorbed COVID-19 (Inactivated) Vaccine
- Registration Number
- NCT04845048
- Lead Sponsor
- Butantan Institute
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2549
- 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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Health care professionals between 18 and 59 years old Adsorbed COVID-19 (Inactivated) Vaccine Health care professionals General population 60 and 74 years old Adsorbed COVID-19 (Inactivated) Vaccine Elderly between 60-74y General population 75 years old or more Adsorbed COVID-19 (Inactivated) Vaccine Elderly 75y plus
- Primary Outcome Measures
Name Time Method Safety of the Adsorbed COVID-19 (inactivated) Vaccine through the incidence of participants who presented adverse reactions according to the age group 7 days after each dose of the vaccine Frequency of participants who presented any solicited and non-solicited local and systemic adverse reactions according to age group and severity.
Safety of the Adsorbed COVID-19 (inactivated) Vaccine through the incidence of adverse reactions. 7 days after each dose of the vaccine Frequency of solicited and non-solicited local and systemic adverse reactions according to age group and severity.
- Secondary Outcome Measures
Name Time Method Description of medications used after adverse event (AE) The whole period of study (365 days after the second dose) Description of medications and duration used after adverse event
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 Frequency of solicited and non-solicited local and systemic adverse reactions, which required medical care according to the dose and severity.
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. Frequency of solicited and non-solicited local and systemic adverse reactions, which required medical care according to the dose and severity.
Safety of the Adsorbed COVID-19 (inactivated) Vaccine through the incidence of adverse reactions. First 30 minutes after each dose of the vaccine. Frequency of solicited and non-solicited local and systemic adverse reactions according to the dose, severity and age group.
Incidence of serious adverse event (AE) The whole period of study (365 days after the second dose) Incidence of serious adverse event
Incidence of adverse event of special interest (AESI) The whole period of study (365 days after the second dose) Incidence of adverse event of special interest
Incidence of serious adverse event if a subject get pregnant (SAE) From the recrod of pregnancy until the end of the study or upto the birth. Incidence of serious adverse event if a subject get pregnant after received any dose of the vaccine
Trial Locations
- Locations (3)
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 Saúde Escola da Faculdade de Medicina de Botucatu - Unesp.
🇧🇷Botucatu, São Paulo, Brazil
Centro de Referência de Imunobiológicos Especiais. Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (CRIEHCFMUSP)
🇧🇷São Paulo, Brazil