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NCT Number: NCT03777163

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

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.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Unidade de Pesquisa Clínica do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo, Ribeirão Preto, São Paulo, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

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.

Primary outcomes

  1. 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.

  2. Adverse events occurring over the immediate 30-minute post vaccination

    Time frame: 30-minute post vaccination

    Immediate Reactogenicity

  3. 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

  4. 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

  5. Number of participants with unsolicited adverse events up to 3 days after vaccination.

    Time frame: 3 days after vaccination.

    Unsolicited Adverse Events

  6. 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

Sponsors and collaborators

Lead sponsor

Butantan Institute

Other Gov

Registry information

Official study 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.

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 17, 2018
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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