Safety and Immunogenicity of the Butantan Quadrivalent Influenza Vaccine

NCT03927131 | Completed Phase 3 DMC

• 1 other identifier: FLQ-01-IB
• Study Type: interventional
• Target: 5,822
• Locations: 1 country
• Sites: 12

Brief 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. 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.

Conditions

Influenza, Human

Keywords

Vaccines

Outcome Measures

Primary Outcomes (6)

• 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

  07 days post-vaccination

• 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

  42 days post-vaccination

• Superiority for influenza B/Victoria strain

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

  21 days post-vaccination

• Superiority for influenza B/Yamagata strain

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

  21 days post-vaccination

• 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

  21 days post-vaccination

• 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)

  21 days post-vaccination

Study Arms (6)

QIV-IB

EXPERIMENTAL

Inactivated split-virion quadrivalent influenza vaccine

Biological: QIV-IB

TIVV-IB

ACTIVE COMPARATOR

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

Biological: TIVV-IB

TIVY-IB

ACTIVE COMPARATOR

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

Biological: TIVY-IB

QIV-IB Lot A

EXPERIMENTAL

Inactivated split-virion quadrivalent influenza vaccine - Lot A

Biological: QIV-IB Lot A

QIV-IB Lot B

EXPERIMENTAL

Inactivated split-virion quadrivalent influenza vaccine - Lot B

Biological: QIV-IB Lot B

QIV-IB Lot C

EXPERIMENTAL

Inactivated split-virion quadrivalent influenza vaccine - Lot C

Biological: QIV-IB Lot C

Interventions

QIV-IB BIOLOGICAL

Inactivated split-virion quadrivalent influenza vaccine

QIV-IB

TIVV-IB BIOLOGICAL

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

TIVV-IB

TIVY-IB BIOLOGICAL

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

TIVY-IB

QIV-IB Lot A BIOLOGICAL

Inactivated split-virion quadrivalent influenza vaccine - Lot A

QIV-IB Lot A

QIV-IB Lot B BIOLOGICAL

Inactivated split-virion quadrivalent influenza vaccine - Lot B

QIV-IB Lot B

QIV-IB Lot C BIOLOGICAL

Inactivated split-virion quadrivalent influenza vaccine - Lot C

QIV-IB Lot C

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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
• Seasonal influenza vaccination in the current year

Sponsors & Collaborators

• Butantan Institute: lead
• Butantan Foundation: collaborator

Study Sites (12)

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

Fortaleza, Ceará, 60430-275, Brazil

Location

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

Fortaleza, Ceará, 60430-275, Brazil

Location

Centro de Pesquisa e desenvolvimento de fármacos (Site BHZ01)

Belo Horizonte, Minas Gerais, 30750-140, Brazil

Location

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

Recife, Pernambuco, 52010-902, Brazil

Location

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

Pelotas, Rio Grande do Sul, 96040-010, Brazil

Location

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

Porto Alegre, Rio Grande do Sul, 90619-900, Brazil

Location

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

Laranjeiras, Sergipe, 49170-000, Brazil

Location

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

Ribeirão Preto, São Paulo, 14055-380, Brazil

Location

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

São Caetano do Sul, São Paulo, 09530-700, Brazil

Location

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, Brazil

Location

Centro de Pesquisa Clínica Serrana (Site RAO03)

Serrana, São Paulo, 14150-000, Brazil

Location

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

São Paulo, 05402-000, Brazil

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Fernanda Castro Boulos, MD

  Instituto Butantan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: April 25, 2019
• Study Start: May 12, 2021
• Primary Completion: October 13, 2023
• Study Completion: March 13, 2024
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (12)