Active Pharmacovigilance Study of Adsorbed COVID-19 (Inactivated) Vaccine
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
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The immunization schedule is two doses intramuscular injections (deltoid) with a 14-28 days interval.
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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.
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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.
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The total period of participation in the study will be approximately 60 days after completing the two-dose schedule of the vaccine.
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Health care professionals between 18 and 59 years old
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Biological: Adsorbed COVID-19 (Inactivated) Vaccine
Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac/Butantan Institute
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| General population 75 years old or more
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Biological: Adsorbed COVID-19 (Inactivated) Vaccine
Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac/Butantan Institute
|
| General population 60 and 74 years old
|
Biological: Adsorbed COVID-19 (Inactivated) Vaccine
Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac/Butantan Institute
|
Outcome Measures
Primary Outcome Measures
- Incidence of adverse events after receiving the Adsorbed COVID-19 (inactivated) Vaccine [42 days after the second dose of the vaccine]
Incidence of adverse events after receiving the Adsorbed COVID-19 (inactivated) Vaccine that needed health assistance
Secondary Outcome Measures
- Reactogenicity of Adsorbed COVID-19 (inactivated) Vaccine [60 days after receiving the second dose of the vaccine]
o Evaluate the reactogenicity of Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac/ Butantan Institute
- Safety of Adsorbed COVID-19 (inactivated) Vaccine [60 days after receiving the second dose of the vaccine]
o Evaluate safety of Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac/Butantan Institute, estimating the incidence of serious adverse events
- Safety of Adsorbed COVID-19 (inactivated) Vaccine [60 days after receiving the second dose of the vaccine]
o Evaluate safety of Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac/Butantan Institute, estimating the incidence of adverse events of special interest.
- safety of Adsorbed COVID-19 (inactivated) Vaccine [60 days after receiving the second dose of the vaccine]
o Evaluate safety of Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac/Butantan Institute in pregnant women or women who report pregnancy after vaccination.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult allowed to receive the Adsorbed COVID-19 (inactivated) Vaccine according to the Immunization National Plan.
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Informed consent form signed by participant.
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Show voluntary intention to participate in the study and availability throughout the study.
Exclusion Criteria:
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History of severe allergic reactions or anaphylaxis to previous vaccines or allergy to any components of the study vaccine.
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History of fever (axillar temperature ≥ 37,8º C) 72 hours before the vaccine
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Be unavailable during the study period.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centro de Saúde Escola da Faculdade de Medicina de Botucatu - Unesp. | Botucatu | São Paulo | Brazil | |
| 2 | 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 | |
| 3 | Centro de Referência de Imunobiológicos Especiais. Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (CRIEHCFMUSP) | São Paulo | Brazil |
Sponsors and Collaborators
- Butantan Institute
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CFV-01-IB