Influenza VaccinesFLU-05-IBNCT03057483
Active Surveillance for Adverse Events Following Immunization With the Influenza Vaccine Produced at Butantan Institute
An observational study of Influenza Vaccines, run by Butantan Institute at 2 sites in Brazil.
Trial summary
Rationale and background: Since 2013, IB has been performing passive pharmacovigilance activities related to TIV. Objetive: To implement an active surveillance study as part of our pharmacovigilance plan while passive surveillance activities will continue. Read more about this study
- Who is it for?
- Ages 6 months to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza Vaccines
- What is being tested?
- Seasonal Influenza vaccine
- Type of treatment
- Vaccines
- How many people
- 533 participants
- Where
- 2 sitesBrazil
- Study dates
- 6 Apr 2017to 6 Dec 2017
- 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 6 months to 59 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: People eligible for immunization with seasonal influenza vaccine as described: children aged 6m-5y, elderly, health care workers, pregnant and post partum women.
Who may be able to join
- Children between six months and five years old; or
- Pregnant and postpartum women (mothers until 45 days after birth); or
- Health care workers; or
- Elderly (aged 60 years or more); and
- To have indication to be vaccinated against influenza;
- To be available to participate in the study throughout its duration (6 weeks after any vaccine dose administered); and
- 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
UBS Buritis
Boa Vista, Roraima, 69304000
Crie - Unifesp
São Paulo, São Paulo
About this study
Official title: Active Surveillance for Adverse Events Following Immunization With the Trivalent Influenza Vaccine (Split Virion and Inactivated) Produced at Butantan Institute
Rationale and background: Since 2013, IB has been performing passive pharmacovigilance activities related to TIV. Objetive: To implement an active surveillance study as part of our pharmacovigilance plan while passive surveillance activities will continue. Pharmacovigilance data on TIV, via active surveillance, is being implemented in response to WHO requirements for pre-qualification of TIV.
Study Design: This is a prospective cohort study. Population: Target groups for vaccination defined by The National Immunization Program of Brazil: children between six months and five years old; pregnant women; postpartum women (mothers until 45 days after birth); healthcare workers; and elderly (people over 60 years old). Study Size: A total of 900 individuals (300 health care workers, 300 elderly, 100 pregnant women, 100 post-partum women and 100 children between six months and five years old), presenting for immunization with IB TIV, and who agree to participate after providing Informed Consent.
Data Analyses: Descriptive approaches will be used to meet the defined objectives described in the protocol, as well as formal statistical tests when appropriate.
Read the detailed description
Primary objective: to characterize and estimate the incidence of solicited adverse events following immunization (AEFI) associated with administration of the trivalent influenza vaccine produced at Butantan Institute (TIV).
Secondary objectives: 1) to characterize and estimate the incidence of overall (solicited and unsolicited) AEFI associated with administration of TIV; 2) to characterize and estimate the incidence of unsolicited AEFI associated with administration of TIV.
Study Design: This is a prospective cohort study aimed at identifying and evaluating adverse events following immunization among individuals vaccinated with TIV during the national immunization campaign. The design will include active surveillance by phone contact and through visits to the study site. Health facilities will be designated and set up as sentinel sites to enroll individuals being vaccinated with IB TIV for active follow up of solicited AEFI occurring within the first 14 days post-vaccination, and unsolicited AEFI up to 6 weeks post-vaccination.
Population: The following groups are targeted groups for the national immunization campaign and will be recruited for participation in this study:
- children between six months and five years old;
- pregnant women; postpartum women (mothers until 45 days after birth);
- healthcare workers; and
- elderly (people over 60 years old).
Variables: Solicited AEFI to be monitored will include local reactions (erythema, pain, swelling, ecchymosis, pruritus and induration), systemic reactions (headache, fever, malaise, arthralgia, myalgia, rash, chills, pruritus, fatigue, sweating) and irritability and persistent crying (for children than 6 years). Unsolicited AEFI reported over the period up to 6 weeks post-vaccination will be recorded. All adverse events reported in the study will be MedDRA coded. Other variables of interest in the study are demographic information of study participants: date of birth, gender, age, ethnicity, as well as vaccination information including date of immunization, site, and vaccine lot.
Data Sources: Study information including signs and symptoms following immunization with TIV will be recorded daily for 14 days post immunization, and will be recorded in the participant's study file.
Study Size: A total of 900 individuals (300 health care workers, 300 elderly, 100 pregnant women, 100 post-partum women and 100 children between six months and five years old), presenting for immunization with IB TIV, and who agree to participate after providing Informed Consent, will be enrolled in the study by study staff.
Data Analyses: Descriptive approaches will be used to meet the defined objectives described in the protocol, as well as formal statistical tests when appropriate. Incidence rates (IR) of AEFI with TIV will be calculated as the number of events divided by the total number of participants exposed to TIV in each of the targeted groups over the period of follow up. IR will be calculated based on total person time of follow-up, 95% confidence intervals will be calculated.
- Conditions
- Influenza Vaccines
- Being tested
- Seasonal Influenza vaccine
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seasonal Influenza vaccineBiological
Also called Flu vaccine
Seasonal Influenza vaccine
| Study group | Role | What they receive |
|---|---|---|
| Elderly | People over 60 years of age. seasonal influenza vaccine Receives: Biological: Seasonal Influenza vaccine | |
| Health care workers | People working in health care services seasonal influenza vaccine Receives: Biological: Seasonal Influenza vaccine | |
| Pregnant women | Pregnant women seasonal influenza vaccine Receives: Biological: Seasonal Influenza vaccine | |
| Post partum women | Women who have given birth < 45 days seasonal influenza vaccine Receives: Biological: Seasonal Influenza vaccine | |
| Children | Children from 6 months to 5 years of age seasonal influenza vaccine Receives: Biological: Seasonal Influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Solicited adverse events following immunization with trivalent influenza vaccine produced by Butantan Institute
Solicited adverse events following immunization with trivalent influenza vaccine produced by Butantan Institute
Measured: study period follow up, approximately 6 months
Secondary outcomes (2)
Solicited and unsolicited adverse events following immunization with trivalent influenza vaccine produced by Butantan Institute
Solicited and unsolicited adverse events following immunization with trivalent influenza vaccine produced by Butantan Institute
Measured: study period follow up, approximately 6 months
Unsolicited adverse events following immunization with trivalent influenza vaccine produced by Butantan Institute
Unsolicited adverse events following immunization with trivalent influenza vaccine produced by Butantan Institute
Measured: study period follow up, approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2017
- Study start6 Apr 2017
- Primary completion6 Sep 2017
- Study completion6 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Influenza VaccinesStudies 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
- 533 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butantan Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Lily Weckx, MD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03057483
- Sponsor's protocol ID
- FLU-05-IB
- Acronym
- FLU-05-IB
- Status last verified
- Jul 2017
- First submitted
- 9 Feb 2017
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gattas VL, Braga PE, Koike ME, Lucchesi MBB, Oliveira MMM, Piorelli RO, Queiroz V, Precioso AR. Safety assessment of seasonal trivalent influenza vaccine produced by Instituto Butantan from 2013 to 2017. Rev Inst Med Trop Sao Paulo. 2018 Dec 20;61:e4. doi: 10.1590/S1678-9946201961004.
PubMed 30570077
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. 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 (Split Virion and Inactivated) Produced at Butantan Institute
- ClinicalTrials.gov ID
- NCT03057483
- Acronym / sponsor ID
- FLU-05-IB / FLU-05-IB
- Conditions
- Influenza Vaccines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 533 participants (actual)
- Lead sponsor
- Butantan InstituteOther government
- Study start
- 6 Apr 2017 (actual)
- Primary completion
- 6 Sep 2017 (actual)
- Study completion
- 6 Dec 2017 (actual)
- First posted
- 20 Feb 2017 (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, IB has been performing passive pharmacovigilance activities related to TIV. Objetive: To implement an active surveillance study as part of our pharmacovigilance plan while passive surveillance activities will continue. Pharmacovigilance data on TIV, via active surveillance, is being implemented in response to WHO requirements for pre-qualification of TIV.
Study Design: This is a prospective cohort study. Population: Target groups for vaccination defined by The National Immunization Program of Brazil: children between six months and five years old; pregnant women; postpartum women (mothers until 45 days after birth); healthcare workers; and elderly (people over 60 years old). Study Size: A total of 900 individuals (300 health care workers, 300 elderly, 100 pregnant women, 100 post-partum women and 100 children between six months and five years old), presenting for immunization with IB TIV, and who agree to participate after providing Informed Consent.
Data Analyses: Descriptive approaches will be used to meet the defined objectives described in the protocol, as well as formal statistical tests when appropriate.
Detailed description
Primary objective: to characterize and estimate the incidence of solicited adverse events following immunization (AEFI) associated with administration of the trivalent influenza vaccine produced at Butantan Institute (TIV).
Secondary objectives: 1) to characterize and estimate the incidence of overall (solicited and unsolicited) AEFI associated with administration of TIV; 2) to characterize and estimate the incidence of unsolicited AEFI associated with administration of TIV.
Study Design: This is a prospective cohort study aimed at identifying and evaluating adverse events following immunization among individuals vaccinated with TIV during the national immunization campaign. The design will include active surveillance by phone contact and through visits to the study site. Health facilities will be designated and set up as sentinel sites to enroll individuals being vaccinated with IB TIV for active follow up of solicited AEFI occurring within the first 14 days post-vaccination, and unsolicited AEFI up to 6 weeks post-vaccination.
Population: The following groups are targeted groups for the national immunization campaign and will be recruited for participation in this study:
- children between six months and five years old;
- pregnant women; postpartum women (mothers until 45 days after birth);
- healthcare workers; and
- elderly (people over 60 years old).
Variables: Solicited AEFI to be monitored will include local reactions (erythema, pain, swelling, ecchymosis, pruritus and induration), systemic reactions (headache, fever, malaise, arthralgia, myalgia, rash, chills, pruritus, fatigue, sweating) and irritability and persistent crying (for children than 6 years). Unsolicited AEFI reported over the period up to 6 weeks post-vaccination will be recorded. All adverse events reported in the study will be MedDRA coded. Other variables of interest in the study are demographic information of study participants: date of birth, gender, age, ethnicity, as well as vaccination information including date of immunization, site, and vaccine lot.
Data Sources: Study information including signs and symptoms following immunization with TIV will be recorded daily for 14 days post immunization, and will be recorded in the participant's study file.
Study Size: A total of 900 individuals (300 health care workers, 300 elderly, 100 pregnant women, 100 post-partum women and 100 children between six months and five years old), presenting for immunization with IB TIV, and who agree to participate after providing Informed Consent, will be enrolled in the study by study staff.
Data Analyses: Descriptive approaches will be used to meet the defined objectives described in the protocol, as well as formal statistical tests when appropriate. Incidence rates (IR) of AEFI with TIV will be calculated as the number of events divided by the total number of participants exposed to TIV in each of the targeted groups over the period of follow up. IR will be calculated based on total person time of follow-up, 95% confidence intervals will be calculated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Elderly | – | Biological: Seasonal Influenza vaccinePeople over 60 years of age. seasonal influenza vaccine |
| Health care workers | – | Biological: Seasonal Influenza vaccinePeople working in health care services seasonal influenza vaccine |
| Pregnant women | – | Biological: Seasonal Influenza vaccinePregnant women seasonal influenza vaccine |
| Post partum women | – | Biological: Seasonal Influenza vaccineWomen who have given birth < 45 days seasonal influenza vaccine |
| Children | – | Biological: Seasonal Influenza vaccineChildren from 6 months to 5 years of age seasonal influenza vaccine |
Who may qualify
- Ages
- 6 months to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- People eligible for immunization with seasonal influenza vaccine as described: children aged 6m-5y, elderly, health care workers, pregnant and post partum women.
Key inclusion criteria (7 listed)
- Children between six months and five years old; or
- Pregnant and postpartum women (mothers until 45 days after birth); or
- Health care workers; or
- Elderly (aged 60 years or more); and
- To have indication to be vaccinated against influenza;
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 vaccineAlso: Flu vaccineSeasonal Influenza vaccine | Biological | Children, Elderly, Health care workers, Post partum women, Pregnant women |
Primary outcome
Solicited adverse events following immunization with trivalent influenza vaccine produced by Butantan Institute
Time frame: study period follow up, approximately 6 months
Solicited adverse events following immunization with trivalent influenza vaccine produced by Butantan Institute
2 secondary outcomes
Solicited and unsolicited adverse events following immunization with trivalent influenza vaccine produced by Butantan Institute
Time frame: study period follow up, approximately 6 months
Unsolicited adverse events following immunization with trivalent influenza vaccine produced by Butantan Institute
Time frame: study period follow up, approximately 6 months
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 17 Jan 2018.
- Derived from this study: PubMed 30570077Gattas VL, Braga PE, Koike ME, Lucchesi MBB, Oliveira MMM, Piorelli RO, Queiroz V, Precioso AR. Safety assessment of seasonal trivalent influenza vaccine produced by Instituto Butantan from 2013 to 2017. Rev Inst Med Trop Sao Paulo. 2018 Dec 20;61:e4. doi: 10.1590/S1678-9946201961004.
- Individual participant dataSharing planned: No
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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.
Lily Weckx, MD principal investigator
Federal University of São Paulo
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 Vaccines, 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 7 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 17 Jan 2018. 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?
Solicited adverse events following immunization with trivalent influenza vaccine produced by Butantan Institute (time frame: study period follow up, approximately 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03057483, which also lists 1 linked publication.
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 17 Jan 2018.