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Safety and Immunogenicity of the Butantan Quadrivalent Influenza Vaccine

NCT03927131 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 5822

Last updated 2025-02-21

No results posted yet for this study

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

Interventions

BIOLOGICAL

QIV-IB

Inactivated split-virion quadrivalent influenza vaccine

BIOLOGICAL

TIVV-IB

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

BIOLOGICAL

TIVY-IB

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

BIOLOGICAL

QIV-IB Lot A

Inactivated split-virion quadrivalent influenza vaccine - Lot A

BIOLOGICAL

QIV-IB Lot B

Inactivated split-virion quadrivalent influenza vaccine - Lot B

BIOLOGICAL

QIV-IB Lot C

Inactivated split-virion quadrivalent influenza vaccine - Lot C

Sponsors & Collaborators

  • Butantan Foundation

    collaborator UNKNOWN

  • Butantan Institute

    lead OTHER_GOV

Principal Investigators

  • Fernanda Castro Boulos, MD · Instituto Butantan

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-12
Primary Completion
2023-10-13
Completion
2024-03-13

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03927131 on ClinicalTrials.gov