SARS-CoV-2 Acute Respiratory DiseaseNCT04845048
Active Pharmacovigilance Study of Adsorbed COVID-19 (Inactivated) Vaccine
An observational study of SARS-CoV-2 Acute Respiratory Disease, run by Butantan Institute at 3 sites in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2 Acute Respiratory Disease
- What is being tested?
- Adsorbed COVID-19 (Inactivated) Vaccine
- Type of treatment
- Vaccines
- How many people
- 2,549 participants
- Where
- 3 sitesBrazil
- Study dates
- 10 May 2021to 13 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Brazil3 sites
Centro de Saúde Escola da Faculdade de Medicina de Botucatu - Unesp.
Botucatu, São Paulo
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
Centro de Referência de Imunobiológicos Especiais. Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (CRIEHCFMUSP)
São Paulo
About this study
Official title: Active Pharmacovigilance Study of Post-vaccine Adverse Events of Sinovac's/ Butantan Institute Adsorbed COVID-19 (Inactivated) Vaccine
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.
Read the 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.
- Conditions
- SARS-CoV-2 Acute Respiratory Disease
- Being tested
- Adsorbed COVID-19 (Inactivated) Vaccine
- Keywords
- COVID-19, Adsorbed COVID-19 vaccine (inactivated), Pharmacovigilance
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adsorbed COVID-19 (Inactivated) VaccineBiological
Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac/Butantan Institute
| Study group | Role | What they receive |
|---|---|---|
| Health care professionals between 18 and 59 years old | Health care professionals Receives: Biological: Adsorbed COVID-19 (Inactivated) Vaccine | |
| General population 75 years old or more | Elderly 75y plus Receives: Biological: Adsorbed COVID-19 (Inactivated) Vaccine | |
| General population 60 and 74 years old | Elderly between 60-74y Receives: Biological: Adsorbed COVID-19 (Inactivated) Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days after each dose of the vaccine
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.
Measured: 7 days after each dose of the vaccine
Secondary outcomes (7)
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.
Measured: 42 days after any dose of the vaccine
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.
Measured: 365 days after the second dose of the vaccine.
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.
Measured: First 30 minutes after each dose of the vaccine.
Incidence of serious adverse event (AE)
Incidence of serious adverse event
Measured: The whole period of study (365 days after the second dose)
Description of medications used after adverse event (AE)
Description of medications and duration used after adverse event
Measured: The whole period of study (365 days after the second dose)
Incidence of adverse event of special interest (AESI)
Incidence of adverse event of special interest
Measured: The whole period of study (365 days after the second dose)
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
Measured: From the recrod of pregnancy until the end of the study or upto the birth.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start10 May 2021
- Primary completion12 Mar 2023
- Study completion13 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 Acute Respiratory DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,549 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butantan Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Marta H Lopes, MD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04845048
- Sponsor's protocol ID
- CFV-01-IB
- Other IDs
- Instituto Butantan
- Status last verified
- May 2023
- First submitted
- 12 Apr 2021
- Last updated
- 22 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Pharmacovigilance Study of Post-vaccine Adverse Events of Sinovac's/ Butantan Institute Adsorbed COVID-19 (Inactivated) Vaccine
- ClinicalTrials.gov ID
- NCT04845048
- Acronym / sponsor ID
- CFV-01-IB
- Conditions
- SARS-CoV-2 Acute Respiratory Disease
- Keywords
- COVID-19, Adsorbed COVID-19 vaccine (inactivated), Pharmacovigilance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,549 participants (actual)
- Lead sponsor
- Butantan InstituteOther government
- Study start
- 10 May 2021 (actual)
- Primary completion
- 12 Mar 2023 (actual)
- Study completion
- 13 Mar 2023 (actual)
- First posted
- 14 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Health care professionals between 18 and 59 years old | – | Biological: Adsorbed COVID-19 (Inactivated) VaccineHealth care professionals |
| General population 75 years old or more | – | Biological: Adsorbed COVID-19 (Inactivated) VaccineElderly 75y plus |
| General population 60 and 74 years old | – | Biological: Adsorbed COVID-19 (Inactivated) VaccineElderly between 60-74y |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adsorbed COVID-19 (Inactivated) VaccineAdsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac/Butantan Institute | Biological | General population 60 and 74 years old, General population 75 years old or more, Health care professionals between 18 and 59 years old |
Primary outcome
Safety of the Adsorbed COVID-19 (inactivated) Vaccine through the incidence of adverse reactions.
Time frame: 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.
Safety of the Adsorbed COVID-19 (inactivated) Vaccine through the incidence of participants who presented adverse reactions according to the age group
Time frame: 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.
7 secondary outcomes
Safety of the Adsorbed COVID-19 (inactivated) Vaccine through the incidence of adverse reactions which needed medical care in participants >= 18 years.
Time frame: 42 days after any dose of the vaccine
Safety of the Adsorbed COVID-19 (inactivated) Vaccine through the incidence of adverse reactions which required medical care in participants < 18 years.
Time frame: 365 days after the second dose of the vaccine.
Safety of the Adsorbed COVID-19 (inactivated) Vaccine through the incidence of adverse reactions.
Time frame: First 30 minutes after each dose of the vaccine.
Incidence of serious adverse event (AE)
Time frame: The whole period of study (365 days after the second dose)
Description of medications used after adverse event (AE)
Time frame: The whole period of study (365 days after the second dose)
Incidence of adverse event of special interest (AESI)
Time frame: The whole period of study (365 days after the second dose)
Incidence of serious adverse event if a subject get pregnant (SAE)
Time frame: From the recrod of pregnancy until the end of the study or upto the birth.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marta H Lopes, MD principal investigator
University of Sao Paulo
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV-2 Acute Respiratory Disease, run by Butantan Institute at 3 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the Adsorbed COVID-19 (inactivated) Vaccine through the incidence of adverse reactions. (time frame: 7 days after each dose of the vaccine). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2023.