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Influenza, HumanPhase 3NCT03927131

Safety and Immunogenicity of the Butantan Quadrivalent Influenza Vaccine

A Phase 3 study testing QIV-IB, TIVV-IB and TIVY-IB in people with Influenza, Human, run by Butantan Institute at 12 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Studies have shown that a broader spectrum influenza vaccine may help in reducing the influenza burden of disease. Butantan Institute is currently developing a quadrivalent influenza vaccine candidate. This study is will provide safety and immunogenicity data on this quadrivalent influenza vaccine candidate. Read more about this study

Who is it for?
Ages 3 years and olderHealthy volunteers can take part
Conditions the study is for
Influenza, Human
What is being tested?
QIV-IB, TIVV-IB and TIVY-IB
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,822 participants
Where
12 sitesBrazil
Study dates
12 May 2021to 13 Mar 2024
Phase
Phase 3
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 3 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Male or female, age 3 years or older at the time of enrollment.
  • Provide written informed consent
  • Agrees to complete all study visits, procedures and contacts
  • Women and adolescents of childbearing age: Negative pregnancy test with understanding (through informed consent process).

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.
  • Women who are pregnant or planning to become pregnant during the study period plus 3 months beyond the last vaccine dose and currently nursing women.
  • Participation in research involving another investigational product within 30 days before planned date of first vaccination or anytime through the last study safety visit.
  • Clinically significant abnormalities on basic laboratory screening tests.
Show all 13Show fewer
  • Acute febrile illness (axillar temperature ≥ 37.8°C)
  • Hypersensitivity to egg or chicken proteins or any of the vaccine constituents
  • 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 of alcohol or drug addiction
  • Any vaccination within the previous 4 weeks
  • Seasonal influenza vaccination in the current year

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Brazil12 sites

  • Centro de Pesquisa e desenvolvimento de fármacos (Site BHZ01)

    Belo Horizonte, Minas Gerais, 30750-140

  • Centro de Pesquisa Clínica Universidade Federal do Ceará - UFC (Site FOR01)

    Fortaleza, Ceará, 60430-275

  • Núcleo de Pesquisa e Desenvolvimento de Medicamentos - NPDM - Universidade Federal do Ceará - UFC (Site FOR 01)

    Fortaleza, Ceará, 60430-275

  • Centro de Pesquisas Clínicas da Universidade Federal de Sergipe (Site AJU01)

    Laranjeiras, Sergipe, 49170-000

  • Centro de Pesquisa Clínica Hospital Escola da Universidade Federal de Pelotas (Site PET01)

    Pelotas, Rio Grande do Sul, 96040-010

  • Centro de Pesquisa Clínica do Hospital São Lucas da PUCRS (Site POA01)

    Porto Alegre, Rio Grande do Sul, 90619-900

  • Centro de Pesquisa Clínica Real Hospital Português de Beneficência em Pernambuco (Site REC01)

    Recife, Pernambuco, 52010-902

  • Centro de Pesquisa Clínica Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (FMRPUSP) (Site RAO01)

    Ribeirão Preto, São Paulo, 14055-380

  • Centro de Pesquisa Clínica da Universidade Municipal de São Caetano do Sul (Site SCS01)

    São Caetano do Sul, São Paulo, 09530-700

  • Centro de Pesquisa Clínica Fundação Faculdade Regional de Medicina de São José do Rio Preto (Site SJP01)

    São José do Rio Preto, São Paulo, 15090-000

  • Centro de Pesquisas Clínicas do Instituto Central da FMUSP Unidade II (Site SAO01)

    São Paulo, 05402-000

  • Centro de Pesquisa Clínica Serrana (Site RAO03)

    Serrana, São Paulo, 14150-000

Other trials in Brazil

About this study

Official title: Double-blind, Randomized Clinical Trial With Active Controls to Assess Safety, Immunogenicity and Lot-to-lot Consistency of Inactivated Split-virion Quadrivalent Influenza Vaccine of Butantan Institute

Studies have shown that a broader spectrum influenza vaccine may help in reducing the influenza burden of disease. Butantan Institute is currently developing a quadrivalent influenza vaccine candidate. This study is will provide safety and immunogenicity data on this quadrivalent influenza vaccine candidate.

The study will be conducted in an open population of healthy participants (3 years old and above) recruited in different clinical sites in Brazil and will be adequately powered to assess safety, immune response (measured by GMT HI antibodies) to each viral strain in the vaccines and lot-to-lot consistency.

Read the detailed description

This is a double blinded, randomized active-control comparator study to assess the safety and immunogenicity of QIV-IB, the Butantan Institute quadrivalent influenza vaccine candidate. As active controls, two trivalent influenza vaccines with different Influenza B strains, one with influenza B/Victoria strain (TIVV-IB) and other with influenza B/Yamagata strain (TIVY-IB).

The study is designed to build a safety database of the quadrivalent influenza vaccine in adults to detect adverse events with a frequency of 1:1000 or higher and safety databases for elderly and pediatric age groups to detect adverse events with frequency of 1:100 or higher.

In terms of immune response, the study aims to demonstrate superiority of HI (Hemagglutinin inhibition) GMT (Geometric Mean Titer) of the QIV-IB for the Influenza B strain that is not present in each trivalent vaccine control. Regarding the Influenza A and B strains common to QIV-IB and both trivalent vaccine controls, the study aims to demonstrate non-inferiority on those strains.

Finally, a lot-to-lot consistency test will be performed in a sub-group of adult participants.

Being tested
QIV-IB, TIVV-IB, TIVY-IB, QIV-IB Lot A, QIV-IB Lot B
Keywords
Vaccines
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QIV-IBBiological

    Inactivated split-virion quadrivalent influenza vaccine

  • TIVV-IBBiological

    Inactivated split-virion trivalent Influenza Vaccine containing Influenza B virus - Victoria lineage

  • TIVY-IBBiological

    Inactivated split-virion trivalent Influenza Vaccine containing Influenza B virus - Yamagata lineage

  • QIV-IB Lot ABiological

    Inactivated split-virion quadrivalent influenza vaccine - Lot A

  • QIV-IB Lot BBiological

    Inactivated split-virion quadrivalent influenza vaccine - Lot B

  • QIV-IB Lot CBiological

    Inactivated split-virion quadrivalent influenza vaccine - Lot C

Study groups in NCT03927131
Study groupRoleWhat they receive
QIV-IBExperimentalInactivated split-virion quadrivalent influenza vaccine
Receives: Biological: QIV-IB
TIVV-IBActive comparatorInactivated split-virion trivalent Influenza Vaccine containing Influenza B virus - Victoria lineage
Receives: Biological: TIVV-IB
TIVY-IBActive comparatorInactivated split-virion trivalent Influenza Vaccine containing Influenza B virus - Yamagata lineage
Receives: Biological: TIVY-IB
QIV-IB Lot AExperimentalInactivated split-virion quadrivalent influenza vaccine - Lot A
Receives: Biological: QIV-IB Lot A
QIV-IB Lot BExperimentalInactivated split-virion quadrivalent influenza vaccine - Lot B
Receives: Biological: QIV-IB Lot B
QIV-IB Lot CExperimentalInactivated split-virion quadrivalent influenza vaccine - Lot C
Receives: Biological: QIV-IB Lot C

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety through number of Adverse Events of QIV-IB, TIVV-IB, TIVY-IB per age group

    Frequency and intensity of solicited and unsolicited adverse reactions

    Measured: 07 days post-vaccination

  2. Safety through number of Adverse Events of QIV-IB, TIVV-IB, TIVY-IB per age group

    Frequency and intensity of unsolicited adverse reactions and adverse events of special interest

    Measured: 42 days post-vaccination

  3. Superiority for influenza B/Victoria strain

    HI GMT ratio for Influenza B/Victoria strains between QIV-IB and TIVY-IB

    Measured: 21 days post-vaccination

  4. Superiority for influenza B/Yamagata strain

    HI GMT ratio for Influenza B/Yamagata strains between QIV-IB and TIVV-IB

    Measured: 21 days post-vaccination

  5. Non-inferiority for common influenza strains between QIV-IB, TIVV-IB and TIVY-IB

    HI GMT ratios for Influenza strains between QIV-IB, TIVV-IB and TIVY-IB

    Measured: 21 days post-vaccination

  6. Lot-to-lot consistency for immune response to different lots of QIV-IB

    HI GMT ratios for Influenza among QIV-IB strains towards among of different lots (A, B and C)

    Measured: 21 days post-vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2019
  2. Study start12 May 2021
  3. Primary completion13 Oct 2023
  4. Study completion13 Mar 2024

Resources

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
5,822 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03927131
Sponsor's protocol ID
FLQ-01-IB
Status last verified
Feb 2025
First submitted
23 Apr 2019
Last updated
21 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing QIV-IB, TIVV-IB and TIVY-IB in people with Influenza, Human, run by Butantan Institute at 12 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 4 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 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Safety through number of Adverse Events of QIV-IB, TIVV-IB, TIVY-IB per age group (time frame: 07 days post-vaccination). 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?

On the ClinicalTrials.gov record for NCT03927131.

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 21 Feb 2025.

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