Influenza, HumanFLU-06-IBNCT03392207
Active Surveillance for Adverse Events Following Immunization With the Butantan Trivalent Influenza Vaccine (2018)
An observational study of Influenza, Human and Orthomyxoviridae Infections, run by Butantan Institute at 2 sites in Brazil.
Trial summary
Rationale and Background: Since 2013, Butantan Institute has been performing passive pharmacovigilance activities related to its triavalent, fragmented and inactivated vaccine (IB TIV). Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Influenza, Human, Orthomyxoviridae Infections, RNA Virus Infections
- What is being tested?
- Seasonal Influenza Vaccine
- Type of treatment
- Vaccines
- How many people
- 403 participants
- Where
- 2 sitesBrazil
- Study dates
- 23 Apr 2018to 14 Sep 2018
- 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 to 130 years
- All sexes
- Adult, Older adult
Study population: People eligible for immunization with seasonal influenza vaccine, focusing on: elderly and health care workers.
Who may be able to join
- Health Care Professional; or
- Elderly (age 60 or more); and
- To have indication to be vaccinated against influenza, according the the Brazilian National Immunazition Programme; and
- To be available to participate in the study throughout its duration (6 weeks after any vaccine dose administered); and
- To demonstrates interest to participate in the study as registered in the informed consent form (ICF).
Who cannot join
- Known systemic hypersensitivity to eggs or to any component of the vaccine;
- Suspected or confirmed fever in the 3 days prior to vaccination or axillary temperature greater than 37.8 ° C on the day of vaccination;
- History of severe adverse reaction after previous administration of an Influenza vaccine within 6 weeks following vaccination;
- History of Guillain-Barre Syndrome or other demyelinating disease;
- Behavioral, cognitive or psychiatric disease that in the opinion of the principal investigator or his representative physician, affects the participant ability to understand and cooperate with all study protocol requirements;
- Any other condition in the opinion of the investigator that justifies exclusion from participation.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Crie - Unifesp
São Paulo, São Paulo
Avenida Vital Brasil 1500
São Paulo, 05503-900
About this study
Official title: Active Surveillance for Adverse Events Following Immunization With the Trivalent Influenza Vaccine (2018 Southern Hemisphere Season) Produced at Butantan Institute
Rationale and Background: Since 2013, Butantan Institute has been performing passive pharmacovigilance activities related to its triavalent, fragmented and inactivated vaccine (IB TIV).
Objetive: To conduct an active surveillance study focusing on the elderly and health care professionals as part of Butantan pharmacovigilance plan, while passive surveillance activities will continue. The pharmacovigilance plan, via active surveillance, is being implemented in response to WHO requirements for pre-qualification of IB TIV.
Read the detailed description
Study Design: This is a prospective cohort study. Population: Target groups for vaccination defined by The National Immunization Program of Brazil: healthcare workers and elderly (people over 60 years old). Study Size: A total of 400 individuals (150 health care workers and 250 elderly), presenting for immunization with IB TIV, and who agree to participate after providing Informed Consent.
- Conditions
- Influenza, Human, Orthomyxoviridae Infections, RNA Virus Infections, Respiratory Tract Infections, Virus Diseases, Vaccines
- Being tested
- Seasonal Influenza Vaccine
- Medical subject headings
- Influenza, Human, Orthomyxoviridae Infections, RNA Virus Infections, Respiratory Tract Infections, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seasonal Influenza VaccineBiological
Trivalent, Fragmented, Inactivated Seasonal Influenza Vaccine (2018 Southern Hemisphere Season) produced at Butantan Institute
| Study group | Role | What they receive |
|---|---|---|
| Health Care Professionals | Health care professionals receiving the seasonal influenza vaccine (2018) produced by Butantan Institute. Receives: Biological: Seasonal Influenza Vaccine | |
| Elderly | Elderly (age 60 or more) receiving the seasonal influenza vaccine (2018) produced by Butantan Institute. Receives: Biological: Seasonal Influenza Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of participants with adverse events following immunization (AEFI), 42 days post-vaccination.
to estimate the incidence of AEFI associated with administration of the trivalent, fragmented, inactivated influenza vaccine (2018 Southern Hemisphere Season) produced at Butantan Institute within 42 days post-vaccination.
Measured: 42 days post-vaccination
Secondary outcomes (3)
number of solicited AEFI, 14 days post-vaccination.
to estimate the incidence of solicited AEFI associated with administration of the trivalent, fragmented, inactivated influenza vaccine (2018 Southern Hemisphere Season) produced at Butantan Institute within 14 days post-vaccination.
Measured: 14 days post-vaccination
number of unsolicited AEFI, 14 days post-vaccination.
to estimate the incidence of unsolicited adverse events following immunization (AEFI) associated with administration of the trivalent, fragmented, inactivated influenza vaccine (2018 Southern Hemisphere Season) produced at Butantan Institute within 14 days post-vaccination.
Measured: 14 days post-vaccination
number of unsolicited AEFI, 42 days post-vaccination.
to estimate the incidence of unsolicited adverse events following immunization (AEFI) associated with administration of the trivalent, fragmented, inactivated influenza vaccine (2018 Southern Hemisphere Season) produced at Butantan Institute within 42 days post-vaccination.
Measured: 42 days post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study start23 Apr 2018
- Primary completion17 Jul 2018
- Study completion14 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza, HumanStudies 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
- 403 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butantan Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Alexander Precioso, MD, PhD, Study director, Instituto Butantan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03392207
- Sponsor's protocol ID
- FLU-06-IB
- Acronym
- FLU-06-IB
- Status last verified
- Jan 2019
- First submitted
- 2 Jan 2018
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- 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 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Surveillance for Adverse Events Following Immunization With the Trivalent Influenza Vaccine (2018 Southern Hemisphere Season) Produced at Butantan Institute
- ClinicalTrials.gov ID
- NCT03392207
- Acronym / sponsor ID
- FLU-06-IB / FLU-06-IB
- Conditions
- Influenza, Human, Orthomyxoviridae Infections, RNA Virus Infections, Respiratory Tract Infections, Virus Diseases, Vaccines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 403 participants (actual)
- Lead sponsor
- Butantan InstituteOther government
- Study start
- 23 Apr 2018 (actual)
- Primary completion
- 17 Jul 2018 (actual)
- Study completion
- 14 Sep 2018 (actual)
- First posted
- 5 Jan 2018 (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.
Rationale and Background: Since 2013, Butantan Institute has been performing passive pharmacovigilance activities related to its triavalent, fragmented and inactivated vaccine (IB TIV).
Objetive: To conduct an active surveillance study focusing on the elderly and health care professionals as part of Butantan pharmacovigilance plan, while passive surveillance activities will continue. The pharmacovigilance plan, via active surveillance, is being implemented in response to WHO requirements for pre-qualification of IB TIV.
Detailed description
Study Design: This is a prospective cohort study. Population: Target groups for vaccination defined by The National Immunization Program of Brazil: healthcare workers and elderly (people over 60 years old). Study Size: A total of 400 individuals (150 health care workers and 250 elderly), presenting for immunization with IB TIV, and who agree to participate after providing Informed Consent.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health Care Professionals | – | Biological: Seasonal Influenza VaccineHealth care professionals receiving the seasonal influenza vaccine (2018) produced by Butantan Institute. |
| Elderly | – | Biological: Seasonal Influenza VaccineElderly (age 60 or more) receiving the seasonal influenza vaccine (2018) produced by Butantan Institute. |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- People eligible for immunization with seasonal influenza vaccine, focusing on: elderly and health care workers.
Key inclusion criteria (5 listed)
- Health Care Professional; or
- Elderly (age 60 or more); and
- To have indication to be vaccinated against influenza, according the the Brazilian National Immunazition Programme; and
- To be available to participate in the study throughout its duration (6 weeks after any vaccine dose administered); and
- To demonstrates interest to participate in the study as registered in the informed consent form (ICF).
Key exclusion criteria (6 listed)
- Known systemic hypersensitivity to eggs or to any component of the vaccine;
- Suspected or confirmed fever in the 3 days prior to vaccination or axillary temperature greater than 37.8 ° C on the day of vaccination;
- History of severe adverse reaction after previous administration of an Influenza vaccine within 6 weeks following vaccination;
- History of Guillain-Barre Syndrome or other demyelinating disease;
- Behavioral, cognitive or psychiatric disease that in the opinion of the principal investigator or his representative physician, affects the participant ability to understand and cooperate with all study protocol requirements;
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 |
|---|---|---|
| Seasonal Influenza VaccineTrivalent, Fragmented, Inactivated Seasonal Influenza Vaccine (2018 Southern Hemisphere Season) produced at Butantan Institute | Biological | Elderly, Health Care Professionals |
Primary outcome
number of participants with adverse events following immunization (AEFI), 42 days post-vaccination.
Time frame: 42 days post-vaccination
to estimate the incidence of AEFI associated with administration of the trivalent, fragmented, inactivated influenza vaccine (2018 Southern Hemisphere Season) produced at Butantan Institute within 42 days post-vaccination.
3 secondary outcomes
number of solicited AEFI, 14 days post-vaccination.
Time frame: 14 days post-vaccination
number of unsolicited AEFI, 14 days post-vaccination.
Time frame: 14 days post-vaccination
number of unsolicited AEFI, 42 days post-vaccination.
Time frame: 42 days post-vaccination
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 16 Jan 2019.
- 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.
Alexander Precioso, MD, PhD study director
Instituto Butantan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza, Human and Orthomyxoviridae Infections, run by Butantan Institute at 2 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 5 inclusion and 6 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 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
number of participants with adverse events following immunization (AEFI), 42 days post-vaccination. (time frame: 42 days post-vaccination). 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 16 Jan 2019.