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

Influenza, Human Clinical Trial

Official title:
A Blind Randomized Clinical Trial, With Active Controls, to Evaluate the Immunogenicity and Safety of the Quadrivalent Influenza Vaccine (Split Virion, Inactivated) From Instituto Butantan, in Infants and Children Aged 6 to 35 Months.

Clinical Trial 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.

Clinical Trial Description

The study will be carried out in multiple sites in Brazil, using a community-based recruitment strategy. The study interventions are the Butantan Quadrivalent Influenza Vaccine (split virion, inactivated) in two dose scheme (QIV-IB/0.25ml and QIV-IB/0.50ml) and the active controls Butantan Trivalent Influenza Vaccine (split virion, inactivated) containing Influenza B virus - Victoria or Yamagata lineage (TIVV-IB and TIVY-IB), in a ratio 1:1:1:1. The study population is healthy infants and children aged 6 to 35 months and all participants will be followed up 6 months after the last vaccination. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05779020
Study type Interventional
Source Butantan Institute
Contact Fernanda Boulos, M.D./PhD.
Phone +55 11 3723-2150
Email fernanda.boulos@butantan.gov.br
Status Recruiting
Phase Phase 3
Start date April 25, 2023
Completion date October 15, 2024
View Details
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