InfluenzaPhase 4NCT03777163
Safety and Immunogenicity of the Butantan Institute Influenza Vaccine Compared to Sanofi Pasteur Influenza Vaccine
A Phase 4 study testing Butantan Institute Trivalent Seasonal Influenza Vaccine and Sanofi Trivalent Seasonal Influenza Vaccine in people with Influenza, run by Butantan Institute at 4 sites in Brazil.
Trial summary
The overall aim of this study is to evaluate the safety and immunogenicity of Butantan Institute Trivalent Seasonal Influenza Vaccine in comparison with the Sanofi Trivalent Seasonal Influenza Vaccine. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Butantan Institute Trivalent Seasonal Influenza Vaccine and Sanofi Trivalent Seasonal Influenza Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 632 participants
- Where
- 4 sitesBrazil
- Study dates
- 22 Apr 2019to 30 Mar 2020
- Phase
- Phase 4
- 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 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult, male or female, age 18 to 69 years (inclusive) at the time of enrollment;
- Provide written informed consent;
- Agrees to complete all study visits, procedures and contacts;
Who cannot join
- Chronic medical conditions such as psychiatric conditions, diabetes, hypertension or any other conditions that might place the subjects at high risk of adverse events. Study clinicians will use clinical judgment on a case-by-case basis to assess safety risks under this criterion;
- Clinically significant abnormalities on physical examination;
- Use of immunosuppressive medications such as systemic corticosteroids or chemotherapeutics, or immunosuppressive illness. It will be considered immunosuppressive dose of systemic corticosteroids the equivalent to a dose ≥10 mg of prednisone per day for over 14 days;
- Women who report being pregnant or have plans to become pregnant during the study period;
- Participation in research involving another investigational product within 30 days before planned date of first vaccination or anytime through the last study safety visit;
- Acute febrile illness (axilar temperature ≥ 37.8°C);
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- Hypersensitivity to egg or chicken proteins;
- History of Guillain-Barre Syndrome;
- Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination;
- Unstable chronic illness (defined as illness requiring hospitalization or a clinically significant change in medication in the previous 12 weeks);
- Alcohol abuse or drug addiction;
- Any vaccination within the previous 4 weeks;
- Seasonal influenza vaccination in the previous 6 months.
Trial locations and contacts
4 sites in 1 country.
Brazil4 sites
Unidade de Pesquisa Clínica do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Ribeirão Preto, São Paulo, 14049900
Centro de Referências para Imunobiológicos Especiais da Universidade Federal de São Paulo
São Paulo, São Paulo, 01220200
Centro de Pesquisas Clínicas do Instituto da Criança do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, 05403 000
Centro de Referência de Imunobiológicos Especiais (CRIE) Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, 05403-000
About this study
Official title: Safety and Immunogenicity of the Butantan Institute Trivalent Seasonal Influenza Vaccine in Comparison With the Sanofi Pasteur Trivalent Seasonal Influenza Vaccine in Brazilian Subjects.
The overall aim of this study is to evaluate the safety and immunogenicity of Butantan Institute Trivalent Seasonal Influenza Vaccine in comparison with the Sanofi Trivalent Seasonal Influenza Vaccine.
Read the detailed description
To detemine whether immunogenicity elicited by a single-dose Butantan Institute Trivalent Seasonal Influenza Vaccine is not inferior to that elicited by a single dose of Sanofi Trivalent Seasonal Influenza Vaccine in adult and elderly populations measured by HI GMT for the three vaccine components 21 days post-immunization.
To describe the safety profile of Butantan Institute Trivalent Seasonal Influenza Vaccine and Sanofi Trivalent Seasonal Influenza Vaccine after a single dose in adult and elderly populations.
- Conditions
- Influenza
- Being tested
- Butantan Institute Trivalent Seasonal Influenza Vaccine, Sanofi Trivalent Seasonal Influenza Vaccine
- Keywords
- Vaccine, Immunization, Safety, Immunogenicity
- 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 Institute Trivalent Seasonal Influenza VaccineBiological
Butantan Institute and Pasteur-Mérieux (present, Sanofi Pasteur) established a technology transfer in 1999 for the production of a trivalent influenza vaccine of inactivated split-virion using embryonated eggs. The technology transfer followed a progressive approach from importing the finished product, to packaging and quality control test for release (1999), and, finally, to the first batch of influenza vaccine entirely produced by Butantan (2011). In 2013, the Butantan vaccine was registered by the Brazilian National Agency of Sanitary Surveillance (ANVISA).
Sanofi Trivalent Seasonal Influenza VaccineBiological
VAXIGRIP® was launched in 1968 and since then has been licensed in more than 100 countries and prequalified by WHO in 2011. Several clinical studies by Sanofi Pasteur have examined the safety and immunogenicity of Vaxigrip® in older children (8-10 years), adults (18-59 years), elderly (> 60 years),11,12 children (six months to three years) 13 and pregnant women.
| Study group | Role | What they receive |
|---|---|---|
| Butantan Trivalent Influenza Vaccine | Other | Butantan Institute Trivalent Seasonal Influenza Vaccine (IB-TIV): 15 μg influenza A/H1N1 antigen + 15 μg influenza A/H3N2 antigen + 15 μg influenza B antigen
Patients will receive one dose (0,5 ml) via intramuscular injection. Receives: Biological: Butantan Institute Trivalent Seasonal Influenza Vaccine |
| Sanofi Trivalent Influenza Vaccine | Other | Sanofi Trivalent Seasonal Influenza Vaccine (IB-TIV): 15 μg influenza A/H1N1 antigen + 15 μg influenza A/H3N2 antigen + 15 μg influenza B antigen
Patients will receive one dose (0,5 ml) via intramuscular injection. Receives: Biological: Sanofi Trivalent Seasonal Influenza Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Titers of Hemaglutination Inhibition (HI) for each of the three vaccine components.
HI titers will be determined in serum samples collected before vaccination and 21 days after vaccination from all the subjects.
Measured: 21 days
Adverse events occurring over the immediate 30-minute post vaccination
Immediate Reactogenicity
Measured: 30-minute post vaccination
Number of participants with solicited local AE (erythema, swelling, induration, pain, tenderness, ecchymosis, pruritus) until 3 days post vaccination.
Solicited Local Adverse Events
Measured: 3 days post vaccination
Number of participants with solicited systemic AEs (fever, fatigue, malaise, myalgia, arthralgia, chills, nausea, vomiting, and headache) until 3 days post vaccination.
Solicited Systemic Adverse Events
Measured: 3 days post vaccination
Number of participants with unsolicited adverse events up to 3 days after vaccination.
Unsolicited Adverse Events
Measured: 3 days after vaccination.
All adverse reactions with severity graded 3/4 over the entire study period.
Adverse Reactions with severity graded 3/4
Measured: 180 days after vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2018
- Study start22 Apr 2019
- Primary completion15 Jan 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 632 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
- NCT03777163
- Sponsor's protocol ID
- FLU-07-IB
- Status last verified
- May 2026
- First submitted
- 12 Dec 2018
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of the Butantan Institute Trivalent Seasonal Influenza Vaccine in Comparison With the Sanofi Pasteur Trivalent Seasonal Influenza Vaccine in Brazilian Subjects.
- ClinicalTrials.gov ID
- NCT03777163
- Acronym / sponsor ID
- FLU-07-IB
- Conditions
- Influenza
- Keywords
- Vaccine, Immunization, Safety, Immunogenicity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 632 participants (actual)
- Lead sponsor
- Butantan InstituteOther government
- Study start
- 22 Apr 2019 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 17 Dec 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.
The overall aim of this study is to evaluate the safety and immunogenicity of Butantan Institute Trivalent Seasonal Influenza Vaccine in comparison with the Sanofi Trivalent Seasonal Influenza Vaccine.
Detailed description
To detemine whether immunogenicity elicited by a single-dose Butantan Institute Trivalent Seasonal Influenza Vaccine is not inferior to that elicited by a single dose of Sanofi Trivalent Seasonal Influenza Vaccine in adult and elderly populations measured by HI GMT for the three vaccine components 21 days post-immunization.
To describe the safety profile of Butantan Institute Trivalent Seasonal Influenza Vaccine and Sanofi Trivalent Seasonal Influenza Vaccine after a single dose in adult and elderly populations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Butantan Trivalent Influenza Vaccine | Other | Biological: Butantan Institute Trivalent Seasonal Influenza VaccineButantan Institute Trivalent Seasonal Influenza Vaccine (IB-TIV): 15 μg influenza A/H1N1 antigen + 15 μg influenza A/H3N2 antigen + 15 μg influenza B antigen Patients will receive one dose (0,5 ml) via intramuscular injection. |
| Sanofi Trivalent Influenza Vaccine | Other | Biological: Sanofi Trivalent Seasonal Influenza VaccineSanofi Trivalent Seasonal Influenza Vaccine (IB-TIV): 15 μg influenza A/H1N1 antigen + 15 μg influenza A/H3N2 antigen + 15 μg influenza B antigen Patients will receive one dose (0,5 ml) via intramuscular injection. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult, male or female, age 18 to 69 years (inclusive) at the time of enrollment;
- Provide written informed consent;
- Agrees to complete all study visits, procedures and contacts;
Key exclusion criteria (13 listed)
- Chronic medical conditions such as psychiatric conditions, diabetes, hypertension or any other conditions that might place the subjects at high risk of adverse events. Study clinicians will use clinical judgment on a case-by-case basis to assess safety risks under this criterion;
- Clinically significant abnormalities on physical examination;
- Use of immunosuppressive medications such as systemic corticosteroids or chemotherapeutics, or immunosuppressive illness. It will be considered immunosuppressive dose of systemic corticosteroids the equivalent to a dose ≥10 mg of prednisone per day for over 14 days;
- Women who report being pregnant or have plans to become pregnant during the study period;
- Participation in research involving another investigational product within 30 days before planned date of first vaccination or anytime through the last study safety visit;
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 Institute Trivalent Seasonal Influenza VaccineButantan Institute and Pasteur-Mérieux (present, Sanofi Pasteur) established a technology transfer in 1999 for the production of a trivalent influenza vaccine of inactivated split-virion using embryonated eggs. The technology transfer followed a progressive approach from importing the finished product, to packaging and quality control test for release (1999), and, finally, to the first batch of influenza vaccine entirely produced by Butantan (2011). In 2013, the Butantan vaccine was registered by the Brazilian National Agency of Sanitary Surveillance (ANVISA). | Biological | Butantan Trivalent Influenza Vaccine |
| Sanofi Trivalent Seasonal Influenza VaccineVAXIGRIP® was launched in 1968 and since then has been licensed in more than 100 countries and prequalified by WHO in 2011. Several clinical studies by Sanofi Pasteur have examined the safety and immunogenicity of Vaxigrip® in older children (8-10 years), adults (18-59 years), elderly (> 60 years),11,12 children (six months to three years) 13 and pregnant women. | Biological | Sanofi Trivalent Influenza Vaccine |
Primary outcome
Geometric Mean Titers of Hemaglutination Inhibition (HI) for each of the three vaccine components.
Time frame: 21 days
HI titers will be determined in serum samples collected before vaccination and 21 days after vaccination from all the subjects.
Adverse events occurring over the immediate 30-minute post vaccination
Time frame: 30-minute post vaccination
Immediate Reactogenicity
Number of participants with solicited local AE (erythema, swelling, induration, pain, tenderness, ecchymosis, pruritus) until 3 days post vaccination.
Time frame: 3 days post vaccination
Solicited Local Adverse Events
Number of participants with solicited systemic AEs (fever, fatigue, malaise, myalgia, arthralgia, chills, nausea, vomiting, and headache) until 3 days post vaccination.
Time frame: 3 days post vaccination
Solicited Systemic Adverse Events
Number of participants with unsolicited adverse events up to 3 days after vaccination.
Time frame: 3 days after vaccination.
Unsolicited Adverse Events
All adverse reactions with severity graded 3/4 over the entire study period.
Time frame: 180 days after vaccination.
Adverse Reactions with severity graded 3/4
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 11 May 2026.
- 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.
Alexander Precioso, MD, PhD study director
Instituto butantan
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Butantan Institute Trivalent Seasonal Influenza Vaccine and Sanofi Trivalent Seasonal Influenza Vaccine in people with Influenza, run by Butantan Institute at 4 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 13 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 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Geometric Mean Titers of Hemaglutination Inhibition (HI) for each of the three vaccine components. (time frame: 21 days). The study lists 6 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 11 May 2026.