NCT05779020

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

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,373 (actual)
• Sponsor: Butantan Institute · Other Government
• Sex: All
• Age: 6 Months – 35 Months
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Influenza, Human

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-04-25
• Primary completion: 2024-09-12
• Completion: 2025-08-02
• First posted: 2023-03-22
• Last updated: 2025-09-19

Locations

10 sites across 1 country: Brazil