Safety and Immunogenicity of the Butantan Institute Influenza Vaccine Compared to Sanofi Pasteur Influenza Vaccine

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.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: Butantan Institute Trivalent Seasonal Influenza Vaccine; Biological: 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 Type: Interventional
• Enrollment (Actual): 632
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Ribeirão Preto, São Paulo, Brazil, 14049900
      • Unidade de Pesquisa Clínica do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
    • São Paulo, São Paulo, Brazil, 01220200
      • Centro de Referências para Imunobiológicos Especiais da Universidade Federal de São Paulo
    • São Paulo, São Paulo, Brazil, 05403 000
      • 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, Brazil, 05403-000
      • Centro de Referência de Imunobiológicos Especiais (CRIE) Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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;

Exclusion Criteria:

• 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);
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Butantan Trivalent Influenza Vaccine; 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.	Biological: Butantan Institute Trivalent Seasonal Influenza Vaccine; 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).
Other: Sanofi Trivalent Influenza Vaccine; 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.	Biological: Sanofi Trivalent Seasonal Influenza Vaccine; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	21 days
Adverse events occurring over the immediate 30-minute post vaccination	Immediate Reactogenicity	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	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	3 days post vaccination
Number of participants with unsolicited adverse events up to 3 days after vaccination.	Unsolicited Adverse Events	3 days after vaccination.
All adverse reactions with severity graded 3/4 over the entire study period.	Adverse Reactions with severity graded 3/4	180 days after vaccination.

Collaborators and Investigators

• Sponsor: Butantan Institute
• Investigators: Study Director: Alexander Precioso, MD, PhD, Instituto Butantan

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2019
• Primary Completion (Actual): January 15, 2020
• Study Completion (Actual): March 30, 2020

Study Registration Dates

• First Submitted: December 12, 2018
• First Submitted That Met QC Criteria: December 13, 2018
• First Posted (Actual): December 17, 2018

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Safety; Vaccine; Immunogenicity; Immunization
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: FLU-07-IB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No