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Safety and Immunogenicity of the Butantan Quadrivalent Influenza Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03927131
Recruitment Status : Not yet recruiting
First Posted : April 25, 2019
Last Update Posted : October 16, 2019
Sponsor:
Collaborator:
Fundação Butantan
Information provided by (Responsible Party):
Butantan Institute

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 (3-59 years old) 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 Intervention/treatment Phase
Influenza 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 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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6018 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 : April 15, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

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




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



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 59 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female, age 3 to 59 years (inclusive) 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927131


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

Sponsors and Collaborators
Butantan Institute
Fundação Butantan
Investigators
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Study Director: Ricardo Palacios, MD, PhD Instituto Butantan
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Responsible Party: Butantan Institute
ClinicalTrials.gov Identifier: NCT03927131    
Other Study ID Numbers: FLQ-01-IB
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: October 16, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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