An observational study in Influenza, Human, Orthomyxoviridae Infections and RNA Virus Infections, sponsored by Butantan Institute. Completed at 2 sites in Brazil. Open to participants aged 18 Years to 130 Years. Per ClinicalTrials.gov, last updated 2019-01-16.
Sponsored by Butantan Institute · Observational
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Among 13 studies in Influenza, Human by Butantan Institute — none open to participants now, none under way, none of them phase 3. Influenza, Human · Butantan Institute.
Among the 13 studies in Influenza, Human by Butantan Institute, this one is one of 2 that started in 2018, is one of 6 observational ones, and was the 10th registered.
2,358 studies on the registry are indexed under Influenza, Human; 184 are open to participants now.
Browse Influenza, Human studies →None of the 13 studies in Influenza, Human by Butantan Institute is open now. The open studies under Influenza, Human, anywhere →
Of the 121 Influenza, Human studies recruiting now, 66 (55%) set no upper age limit and 45 (37%) stop at 75 or younger; 33 take children under 18; 67 take healthy volunteers.
This study: 18 Years to 130 Years · all sexes.
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13 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 2 started in 2018.
This study's enrollment of 403 is close to the median of 397 across 334 observational studies indexed under Influenza, Human.
Median enrollment 632 across the 7 interventional studies, 262 across the 6 observational. Of the 13 that completed or were terminated, 0 (0%) have results posted.
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Butantan Institute is the lead sponsor of 31 studies on the registry; 3 are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 13 studies in Influenza, Human by Butantan Institute, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
People eligible for immunization with seasonal influenza vaccine, focusing on: elderly and health care workers.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Health care professionals receiving the seasonal influenza vaccine (2018) produced by Butantan Institute.
Biological: Seasonal Influenza Vaccine
Elderly (age 60 or more) receiving the seasonal influenza vaccine (2018) produced by Butantan Institute.
Biological: Seasonal Influenza Vaccine
Trivalent, Fragmented, Inactivated Seasonal Influenza Vaccine (2018 Southern Hemisphere Season) produced at Butantan Institute
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.
Time frame: 42 days post-vaccination
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.
Time frame: 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.
Time frame: 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.
Time frame: 42 days post-vaccination
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Apr 2018 to primary completion in Jul 2018, 2 months.
Of 98 non-industry observational studies under Influenza, Human, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 92. This study's 2 months is below that.
Counting every sponsor, half of 135 studies reached it within 23 months; a quarter within 7 and three quarters within 59.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Butantan Institute