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

NCT03777163 | Completed Phase 4

• 1 other identifier: FLU-07-IB
• Study Type: interventional
• Target: 632
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Influenza

Keywords

Vaccine; Immunization; Safety; Immunogenicity

Outcome Measures

Primary Outcomes (6)

• 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.

Study Arms (2)

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.

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.

Biological: Sanofi Trivalent Seasonal Influenza Vaccine

Interventions

Butantan Institute Trivalent Seasonal Influenza Vaccine BIOLOGICAL

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).

Butantan Trivalent Influenza Vaccine

Sanofi Trivalent Seasonal Influenza Vaccine BIOLOGICAL

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.

Sanofi Trivalent Influenza Vaccine

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Butantan Institute: lead

Study Sites (4)

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, Brazil

Location

Centro de Referências para Imunobiológicos Especiais da Universidade Federal de São Paulo

São Paulo, São Paulo, 01220200, Brazil

Location

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, Brazil

Location

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, Brazil

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Alexander Precioso, MD, PhD

  Instituto butantan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: December 17, 2018
• Study Start: April 22, 2019
• Primary Completion: January 15, 2020
• Study Completion: March 30, 2020
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (4)