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Brazilian flu vaccine put to the test against global standard

NCT ID NCT03777163

Vaccine Sponsor: Butantan Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed Phase 4 trial tested whether the Butantan Institute's seasonal flu vaccine is as safe and effective as the Sanofi vaccine. A total of 632 Brazilian adults aged 18 to 69 received one of the two vaccines. Researchers measured immune response through blood tests and tracked side effects like pain, fever, and fatigue for up to 21 days after vaccination.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Trivalent seasonal influenza vaccine (inactivated, split-virion, egg-based)
What this could lead to
If successful, this could confirm that the Butantan flu vaccine is as safe and effective as the Sanofi vaccine, offering a reliable alternative for seasonal flu prevention.
What could go wrong
This is a completed Phase 4 trial, so results are already in. However, the study only included adults in Brazil, so findings may not apply to other populations or age groups.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

632 people

The number who actually took part.

Started

Apr 2019

Finished

Mar 2020

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 69 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

influenza prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Influenza

Contacts and locations

Locations

  • 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

  • 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

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

    São Paulo, São Paulo, 01220200, Brazil

  • 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

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