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Safety and Immunogenicity of the Butantan Quadrivalent Influenza Vaccine

  • Clinicaltrials.gov identifier

    NCT03927131

  • Recruitment Status

    Not yet recruiting

  • First Posted

    April 25, 2019

  • Last update posted

    February 4, 2021

Study Description

Brief summary:

Studies have showed 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.

  • Condition or Disease:Influenza
  • Intervention/Treatment: Biological: QIV-IB
    Biological: TIVV-IB
    Biological: TIVY-IB
    Biological: QIV-IB Lot A
    Biological: QIV-IB Lot B
    Biological: QIV-IB Lot C
  • Phase: Phase 3

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.

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 6528 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Prevention
  • 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
  • Estimated Study Start Date: May 2021
  • Estimated Primary Completion Date: December 2021
  • Estimated Study Completion Date: December 2021

Arms and interventions

Arm Intervention/treatment
Experimental: QIV-IB
Inactivated split-virion quadrivalent influenza vaccine
Biological: QIV-IB
Inactivated split-virion quadrivalent influenza vaccine
Active Comparator: TIVV-IB
Inactivated split-virion trivalent Influenza Vaccine containing Influenza B virus - Victoria lineage
Biological: TIVV-IB
Inactivated split-virion trivalent Influenza Vaccine containing Influenza B virus - Victoria lineage
Active Comparator: TIVY-IB
Inactivated split-virion trivalent Influenza Vaccine containing Influenza B virus - Yamagata lineage
Biological: TIVY-IB
Inactivated split-virion trivalent Influenza Vaccine containing Influenza B virus - Yamagata lineage
Experimental: QIV-IB Lot A
Inactivated split-virion quadrivalent influenza vaccine - Lot A
Biological: QIV-IB Lot A
Inactivated split-virion quadrivalent influenza vaccine - Lot A
Experimental: QIV-IB Lot B
Inactivated split-virion quadrivalent influenza vaccine - Lot B
Biological: QIV-IB Lot B
Inactivated split-virion quadrivalent influenza vaccine - Lot B
Experimental: QIV-IB Lot C
Inactivated split-virion quadrivalent influenza vaccine - Lot C
Biological: QIV-IB Lot C
Inactivated split-virion quadrivalent influenza vaccine - Lot C

Outcome Measures

  • Primary Outcome Measures: 1. Safety of QIV-IB per age group [ Time Frame: 42 days post-vaccination ]
    Frequency and intensity of adverse events reactions and events of special interest
  • 2. Superiority for influenza B/Victoria strain [ Time Frame: 21 days post-vaccination ]
    HI GMT ratio for Influenza B/Victoria strains between QIV-IB and TIVY-IB
  • 3. Superiority for influenza B/Yamagata strain [ Time Frame: 21 days post-vaccination ]
    HI GMT ratio for Influenza B/Yamagata strains between QIV-IB and TIVY-IB
  • 4. Non-inferiority for common influenza strains between QIV-IB, TIVV-IB and TIVV-IB [ Time Frame: 21 days post-vaccination ]
    HI GMT ratios for Influenza strains between QIV-IB, TIVV-IB and TIVV-IB
  • 5. Lot-to-lot consistency for immune response to different lots of QIV-IB [ Time Frame: 21 days post-vaccination ]
    HI GMT ratios for Influenza strains between QIV-IB, TIVV-IB and TIVV-IB

Eligibility Criteria

  • Ages Eligible for Study: 3 Years and older (Child, Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

- 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).

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.

- 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.

- 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 For immune response groups

- Seasonal influenza vaccination in the previous or current years

Contacts and Locations

Contacts

Contact: Ricardo Palacios, MD, PhD +55 11 3723-2121 ricardo.palacios@butantan.gov.br

Locations

Sponsors and Collaborators

Butantan Institute

Fundação Butantan

Investigators

Study Director: Ricardo Palacios, MD, PhD Instituto Butantan

More Information

  • Responsible Party: Butantan Institute
  • ClinicalTrials.gov Identifier: NCT03927131 History of Changes
  • Other Study ID Numbers: FLQ-01-IB
  • First Posted: April 25, 2019 Key Record Dates
  • Last Update Posted: February 4, 2021
  • Last Verified: February 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Butantan Institute: Vaccine
  • Additional relevant MeSH terms: Influenza, Human