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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04845048
Recruitment Status : Not yet recruiting
First Posted : April 14, 2021
Last Update Posted : April 14, 2021
Sponsor:
Information provided by (Responsible Party):
Butantan Institute

Study Description
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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
Covid19 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 Design
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Study Type : Observational
Estimated Enrollment : 900 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Active Pharmacovigilance Study of Post-vaccine Adverse Events of Sinovac's/ Butantan Institute Adsorbed COVID-19 (Inactivated) Vaccine
Estimated Study Start Date : April 2021
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Health care professionals between 18 and 59 years old Biological: Adsorbed COVID-19 (Inactivated) Vaccine
Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac/Butantan Institute
General population 75 years old or more 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
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Primary Outcome Measures :
  1. Incidence of adverse events after receiving the Adsorbed COVID-19 (inactivated) Vaccine [ Time Frame: 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 :
  1. Reactogenicity of Adsorbed COVID-19 (inactivated) Vaccine [ Time Frame: 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

  2. Safety of Adsorbed COVID-19 (inactivated) Vaccine [ Time Frame: 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

  3. Safety of Adsorbed COVID-19 (inactivated) Vaccine [ Time Frame: 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.

  4. safety of Adsorbed COVID-19 (inactivated) Vaccine [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04845048


Contacts
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Contact: Alexander R Precioso, MD, PhD +55 11 3723-2150 alexander.precioso@butantan.gov.br

Locations
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Brazil
Centro de Saúde Escola da Faculdade de Medicina de Botucatu - Unesp.
Botucatu, São Paulo, Brazil
Contact: Paulo José F Villas Boas, MD, PhD         
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
Contact: Anderson S da Silva, MD, PhD         
Centro de Referência de Imunobiológicos Especiais. Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (CRIEHCFMUSP)
São Paulo, Brazil
Contact: Marta Heloísa Lopes, MD, PhD         
Sponsors and Collaborators
Butantan Institute
More Information
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Responsible Party: Butantan Institute
ClinicalTrials.gov Identifier: NCT04845048    
Other Study ID Numbers: CFV-01-IB
First Posted: April 14, 2021    Key Record Dates
Last Update Posted: April 14, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Butantan Institute:
COVID-19, coronavac, vaccine, SARS-CoV-2
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases