Immunogenicity and Safety of Butantan Quadrivalent Influenza Vaccine (Split Virion, Inactivated) in Infants and Children .

NCT05779020 | Completed Phase 3

• 1 other identifier: FLQ-02-IB
• Study Type: interventional
• Target: 1,373
• Locations: 1 country
• Sites: 10

Brief Summary

This is a Phase III Randomized Clinical Trial, blind, multicenter, with active controls, to evaluate the immunogenicity and safety of the Quadrivalent Influenza Vaccine (split virion, inactivated) from Instituto Butantan, in two dose scheme (0.25ml and 0.50ml), in infants and children under 3 years of age.

Conditions

Influenza, Human

Keywords

Influenza Vaccines

Outcome Measures

Primary Outcomes (4)

• Ratio of Geometric Mean Titers (rGMT) of antibodies induced by QIV-IB/0.25ml compared to those induced by TIVV-IB and TIVY-IB, for each strain, in infants and children from 6 to 35 months of age.

  Immunogenicity outcomes assessed in serum samples by hemagglutination inhibition (HAI) assay.

  28 days after last vaccination

• Ratio of Geometric Mean Titers (rGMT) of antibodies induced by QIV-IB/0.50ml compared to those induced by TIVV-IB and TIVY-IB, for each strain, in infants and children from 6 to 35 months of age.

  Immunogenicity outcomes assessed in serum samples by hemagglutination inhibition (HAI) assay.

  28 days after last vaccination

• Ratio of Geometric Mean Titers (rGMT) of antibodies induced by QIV-IB/0.25ml compared to those induced by TIV that does not contain the B strain, for B lineage Victoria and Yamagata, in infants and children aged 6 to 35 months age.

  Immunogenicity outcomes assessed in serum samples by hemagglutination inhibition (HAI) assay.

  28 days after last vaccination

• Ratio of Geometric Mean Titers (rGMT) of antibodies induced by QIV-IB/0.50ml compared to those induced by TIV that does not contain the B strain, for B lineage Victoria and Yamagata, in infants and children aged 6 to 35 months age.

  Immunogenicity outcomes assessed in serum samples by hemagglutination inhibition (HAI) assay.

  28 days after last vaccination

Secondary Outcomes (8)

• Ratio of Geometric Mean Titers (rGMT) of antibodies induced by QIV-IB/0.50ml compared to those induced by QIV-IB/0.25ml, for each strain, in infants and children from 6 to 35 months of age.

  28 days after last vaccination

• Percentage of Participants With Seroconversion (Seroconversion Rate - SCR) to Influenza Vaccine Antigens.

  At Days 0 and 28/56

• Percentage of Participants achieving seroprotection (Seroprotection Rate - SPR) to Influenza Vaccine Antigens.

  At Days 0 and 28/56

• Pre- and post-vaccination Geometric Mean Titers (GMT) induced by QIV-IB/0.25ml, QIV-IB/0.50ml, TIVV-IB e TIVY-IB, for each strain, in infants and children from 6 to 35 months of age.

  At Days 0 and 28/56

• Ratio of Pre- and post-vaccination Geometric Mean Titers (rGMT) induced by QIV-IB/0.25ml, QIV-IB/0.50ml, TIVV-IB e TIVY-IB, for each strain, in infants and children from 6 to 35 months of age.

  At Days 0 and 28/56

Study Arms (4)

QIV-IB/dose 0.25ml

EXPERIMENTAL

Butantan Quadrivalent Influenza Vaccine (split virion, inactivated)/dose 0.25ml

Biological: Quadrivalent Influenza Vaccine (split virion, inactivated)

QIV-IB/dose 0.50ml

EXPERIMENTAL

Butantan Quadrivalent Influenza Vaccine (split virion, inactivated)/dose 0.50ml

Biological: Quadrivalent Influenza Vaccine (split virion, inactivated)

TIVV-IB

ACTIVE COMPARATOR

Butantan Trivalent Influenza Vaccine (split virion, inactivated)/dose 0.25ml containing Influenza B virus - Victoria lineage

Biological: Trivalent Influenza Vaccine (split virion, inactivated) containing Influenza B virus - Victoria lineage

TIVY-IB

ACTIVE COMPARATOR

Butantan Trivalent Influenza Vaccine (split virion, inactivated)/dose 0.25ml containing Influenza B virus - Yamagata lineage

Biological: Trivalent Influenza Vaccine (split virion, inactivated) containing Influenza B virus - Yamagata lineage

Interventions

Quadrivalent Influenza Vaccine (split virion, inactivated) BIOLOGICAL

Quadrivalent Influenza Vaccine (split virion, inactivated) from Instituto Butantan (dose 0.25ml and 0.50ml)

QIV-IB/dose 0.25ml; QIV-IB/dose 0.50ml

Trivalent Influenza Vaccine (split virion, inactivated) containing Influenza B virus - Victoria lineage BIOLOGICAL

Trivalent Influenza Vaccine (split virion, inactivated) containing Influenza B virus - Victoria lineage/dose 0.50ml

TIVV-IB

Trivalent Influenza Vaccine (split virion, inactivated) containing Influenza B virus - Yamagata lineage BIOLOGICAL

Trivalent Influenza Vaccine (split virion, inactivated) containing Influenza B virus - Yamagata lineage/dose 0.25ml

TIVY-IB

Eligibility Criteria

• Age: 6 Months - 35 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy infant and child of either sex aged between 6 and 35 months on the day of the first study vaccination.
• Born at term (≥ 37 weeks of gestational age) and birth weight ≥ 2.5 kg.
• Parents/legal guardians of the infant or child able and willing to attend all scheduled visits and comply with all study procedures, including blood draws.
• Parents/legal guardians of the infant or child have provided informed consent.

You may not qualify if:

• Having received any influenza vaccine from the current season and/or 6 months before the first study vaccination.
• History of allergy to egg, chicken proteins, or other components of the influenza vaccine.
• History of serious adverse reaction to any influenza vaccine.
• Have any clinically significant condition or situation that, in the Investigator's opinion, would interfere with study evaluations or participation.
• History of Guillain-Barré or other demyelinating diseases.
• History of neurological disease and/or clinically significant developmental delay (at the discretion of the Investigator), or seizure (except for an isolated febrile seizure episode).
• Having received immune globulin, blood, or any blood product 3 months before the planned date of the first study vaccination or planned administration during the study period.
• Any confirmed or suspected immunosuppressive condition, congenital or acquired immunodeficiency (including human immunodeficiency virus - HIV) based on medical history and physical examination.
• Immediate personal or family history of congenital immunodeficiency.
• Having received or are using radiation therapy, chemotherapy, immunosuppressive drugs, or other immunomodulatory drugs within three months before the planned date of the first study vaccination or planned use during the study.
• Be a solid organ or bone marrow/stem cell transplant recipient.
• Thrombocytopenia, bleeding disorder, use of anticoagulants, or any condition that contraindicates intramuscular injection.
• Significant chronic disease (cancer, autoimmune disease, diabetes mellitus, acute or progressive liver disease, acute or progressive kidney disease, severe heart or lung disease) or which in the Investigator's opinion poses a risk to the health of the infant or child participating in the study or which may interfere with the conduct or conclusion of the study.
• History of seropositivity for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
• Major surgery or surgery using general anesthesia planned to occur during the period between the first vaccination and 28 days after full vaccination in the study.

Sponsors & Collaborators

• Butantan Institute: lead
• Fundação Butantan: collaborator

Study Sites (10)

Instituto Auto Imune de Pesquisa e Educação Continuada - Real Hospital Português de Beneficência em Pernambuco (Site REC01)

Recife, Pernambuco, Brazil

Location

Centro Oncológico de Roraima - CECOR (Site BVB-01)

Boa Vista, Roraima, 69304-015, Brazil

Location

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

Laranjeiras, Sergipe, 49170-000, Brazil

Location

Hospital das Clínicas da Faculdade de Medicina Ribeirão Preto - USP (Site RAO 04)

Ribeirão Preto, São Paulo, 14051-140, Brazil

Location

Centro de Pesquisa Clínica S (Site RAO03)

Serrana, São Paulo, Brazil

Location

CPMC Pesquisa Clínica - Clinica De Alergia Martti Antila Sorocaba

Sorocaba, São Paulo, 18040-425, Brazil

Location

A2Z Clinical Centro Avançado de Pesquisa Clínica Ltda.(Site 001)

Valinhos, São Paulo, 13271-130, Brazil

Location

CPQuali Pesquisa Clínica Ltda (Site 002)

São Paulo, 01228-000, Brazil

Location

Instituto de Pesquisa PENSI (Site SAO09)

São Paulo, 01228-200, Brazil

Location

Centro de Pesquisa Clínica do Instituto da Criança - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (Site SAO08)

São Paulo, 05403-000, Brazil

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

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: March 9, 2023
• First Posted: March 22, 2023
• Study Start: April 25, 2023
• Primary Completion: September 12, 2024
• Study Completion: August 2, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (10)