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

NCT05779020 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1373

Last updated 2025-09-19

No results posted yet for this study

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

Interventions

BIOLOGICAL

Quadrivalent Influenza Vaccine (split virion, inactivated)

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

BIOLOGICAL

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

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

BIOLOGICAL

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

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

Sponsors & Collaborators

  • Fundação Butantan

    collaborator UNKNOWN

  • Butantan Institute

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
35 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-25
Primary Completion
2024-09-12
Completion
2025-08-02

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 NCT05779020 on ClinicalTrials.gov