InfluenzaNCT02313740
Prospective Cohort Study to Evaluate Safety/Immunogenicity of Butantan Influenza Vaccine in Healthy Adults/Elderly
An observational study of Influenza, run by Butantan Institute.
Trial summary
Prospective cohort study to evaluate safety and immunogenicity of the fragmented, inactivated trivalent Influenza vaccine produced at Butantan Institute in healthy adults and elderly. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Butantan Fragmented Inactivated Trivalent Influenza Vaccine
- Type of treatment
- Vaccines
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Jun 2015
- 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: Health adults with age between 18 and 59 years, as well as elderly over 60 years of age may participate in the study. To be included in the study, participants need to meet all inclusion criteria, and not fulfill any exclusion criteria.
Who may be able to join
- Healthy adults, male or female aged 18 to 59
- Elderly aged 60 years completed and above
- To be available to participate in the study throughout its duration (approximately 21 days)
- To have medical indication to be vaccinated against influenza
- To demonstrate intention to participate in the study, as documented by signature in the study´s informed consent form.
Who cannot join
- Evidence of active neurological, cardiac, pulmonary, hepatic or renal disease as clinical history and/or physical examination (except hypertension under control among the elderly)
- Compromised immune system diseases including: HIV, diabetes mellitus, cancer (except basal cell carcinoma) and autoimmune diseases
- 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
- Abusive usage of alcohol or drugs in the past 12 months that has caused medical, professional or family problems, indicated by clinical history
- Known systemic hypersensitivity to eggs or to any component of the vaccine
- History of severe adverse reaction after previous administration of an Influenza vaccine within 6 weeks following vaccination
Show all 18Show fewer
- History of Guillain-Barre Syndrome or other demyelinating disease
- Diagnosis of asthma with a history of hospitalization in the last six months due to illness
- Suspected or confirmed fever in the 3 days prior to vaccination or axillary temperature greater than 37.8 ° C on the day of vaccination
- Use of corticosteroids (except topical or nasal) or other immunosuppressive drugs within 42 days before study initiation/baseline. It will be considered immunosuppressive dose of corticosteroids the equivalent to a dose ≥10 mg of prednisone per day for over 14 days
- Impaired coagulation due to chronic disease or due to use anticoagulant medication (warfarin or heparin) in the 7 days preceding vaccination
- Have received live virus vaccine within 28 days or killed virus vaccine in the last 14 days prior to vaccination, or have a scheduled immunization during the first 21 days after vaccination
- Have received influenza vaccine in the past 6 months;
- History of asplenia
- Have received blood products in the past 6 months, including transfusions or immunoglobulin, or scheduled administration of blood products or immunoglobulin for the first 21 days after vaccination
- have a counterindication for Influenza vaccination, including allergy to egg proteins
- Use of any investigational product within 42 days before vaccination;
- Any other condition that might put in risk the safety/rights of a potential participant or hurdle his/her compliance with this protocol in investigator's opinion or his representative physician.
About this study
Official title: Prospective Cohort Study to Evaluate Safety and Immunogenicity of Butantan´s Fragmented, Inactivated Trivalent Influenza Vaccine in Healthy Adults and Elderly
Prospective cohort study to evaluate safety and immunogenicity of the fragmented, inactivated trivalent Influenza vaccine produced at Butantan Institute in healthy adults and elderly. The study will include a total of 120 participants: 60 participants aged 18 to 59 years in the healthy adults group, and 60 participants aged older than 60 years in the elderly group.This study will evaluate the safety of one dose of the fragmented, inactivated trivalent Influenza vaccine in the first 3 days after vaccination, as well as its immunogenicity 21 days after vaccination.
- Conditions
- Influenza
- Being tested
- Butantan Fragmented Inactivated Trivalent Influenza Vaccine
- Keywords
- Influenza, Influenza Vaccines
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Butantan Fragmented Inactivated Trivalent Influenza VaccineBiological
Subjects participating in the study are exposed to Butantan´s Fragmented Inactivated Trivalent Influenza Vaccine during vaccination campaign, and will have immunogenicity and safety related to the vaccine evaluated (observational study).
| Study group | Role | What they receive |
|---|---|---|
| Healthy adults group | Healthy adults aged 18 to 59 years Butantan Fragmented Inactivated Trivalent Influenza Vaccine Receives: Biological: Butantan Fragmented Inactivated Trivalent Influenza Vaccine | |
| Elderly group | Elderly aged over than 60 years completed Butantan Fragmented Inactivated Trivalent Influenza Vaccine Receives: Biological: Butantan Fragmented Inactivated Trivalent Influenza Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccine Immunogenicity
Antibody response to each of the vaccine´s strains as measured by % seroconversion, increase in the geometric mean of hemagglutination-inhibition (HAI) titers and % seroprotection.
Measured: 21 days
Vaccine safety assessed by unsolicited local and systemic adverse reactions up to 3 days post vaccination
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2014 (estimated)
- Study startApr 2015
- Primary completionJun 2015
- Study completionJun 2015
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 InfluenzaStudies 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butantan Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Alex R Precioso, MD, PhD, Study director, Butantan Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02313740
- Sponsor's protocol ID
- FLU-04-IB
- Status last verified
- Jul 2015
- First submitted
- 4 Dec 2014
- Last updated
- 21 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Mondini G, Braga PE, Lopes MH, Sartori AMC, Miyaji KT, Infante V, Randi BA, Timenetsky MDCST, Ferreira JCOA, Sakita NK, Precioso AR. Prospective cohort studies to evaluate the safety and immunogenicity of the 2013, 2014, and 2015 seasonal influenza vaccines produced by Instituto Butantan. Rev Inst Med Trop Sao Paulo. 2018 Jul 30;60:e37. doi: 10.1590/S1678-9946201860037.
PubMed 30066805
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study to Evaluate Safety and Immunogenicity of Butantan´s Fragmented, Inactivated Trivalent Influenza Vaccine in Healthy Adults and Elderly
- ClinicalTrials.gov ID
- NCT02313740
- Acronym / sponsor ID
- FLU-04-IB
- Conditions
- Influenza
- Keywords
- Influenza, Influenza Vaccines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Butantan InstituteOther government
- Study start
- Apr 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 10 Dec 2014 (estimated)
- 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.
Prospective cohort study to evaluate safety and immunogenicity of the fragmented, inactivated trivalent Influenza vaccine produced at Butantan Institute in healthy adults and elderly. The study will include a total of 120 participants: 60 participants aged 18 to 59 years in the healthy adults group, and 60 participants aged older than 60 years in the elderly group.This study will evaluate the safety of one dose of the fragmented, inactivated trivalent Influenza vaccine in the first 3 days after vaccination, as well as its immunogenicity 21 days after vaccination.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy adults group | – | Biological: Butantan Fragmented Inactivated Trivalent Influenza VaccineHealthy adults aged 18 to 59 years Butantan Fragmented Inactivated Trivalent Influenza Vaccine |
| Elderly group | – | Biological: Butantan Fragmented Inactivated Trivalent Influenza VaccineElderly aged over than 60 years completed Butantan Fragmented Inactivated Trivalent Influenza Vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Health adults with age between 18 and 59 years, as well as elderly over 60 years of age may participate in the study. To be included in the study, participants need to meet all inclusion criteria, and not fulfill any exclusion criteria.
Key inclusion criteria (5 listed)
- Healthy adults, male or female aged 18 to 59
- Elderly aged 60 years completed and above
- To be available to participate in the study throughout its duration (approximately 21 days)
- To have medical indication to be vaccinated against influenza
- To demonstrate intention to participate in the study, as documented by signature in the study´s informed consent form.
Key exclusion criteria (18 listed)
- Evidence of active neurological, cardiac, pulmonary, hepatic or renal disease as clinical history and/or physical examination (except hypertension under control among the elderly)
- Compromised immune system diseases including: HIV, diabetes mellitus, cancer (except basal cell carcinoma) and autoimmune diseases
- 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
- Abusive usage of alcohol or drugs in the past 12 months that has caused medical, professional or family problems, indicated by clinical history
- Known systemic hypersensitivity to eggs or to any component of the vaccine
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 |
|---|---|---|
| Butantan Fragmented Inactivated Trivalent Influenza VaccineSubjects participating in the study are exposed to Butantan´s Fragmented Inactivated Trivalent Influenza Vaccine during vaccination campaign, and will have immunogenicity and safety related to the vaccine evaluated (observational study). | Biological | Elderly group, Healthy adults group |
Primary outcome
Vaccine Immunogenicity
Time frame: 21 days
Antibody response to each of the vaccine´s strains as measured by % seroconversion, increase in the geometric mean of hemagglutination-inhibition (HAI) titers and % seroprotection.
Vaccine safety assessed by unsolicited local and systemic adverse reactions up to 3 days post vaccination
Time frame: 3 days
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 21 Jul 2015.
- Derived from this study: PubMed 30066805Mondini G, Braga PE, Lopes MH, Sartori AMC, Miyaji KT, Infante V, Randi BA, Timenetsky MDCST, Ferreira JCOA, Sakita NK, Precioso AR. Prospective cohort studies to evaluate the safety and immunogenicity of the 2013, 2014, and 2015 seasonal influenza vaccines produced by Instituto Butantan. Rev Inst Med Trop Sao Paulo. 2018 Jul 30;60:e37. doi: 10.1590/S1678-9946201860037.
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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.
Alex R Precioso, MD, PhD study director
Butantan Institute
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza, run by Butantan Institute.
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 18 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 21 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Vaccine Immunogenicity (time frame: 21 days). 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?
On the ClinicalTrials.gov record for NCT02313740, 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 21 Jul 2015.