NCT03927131

Safety and Immunogenicity of the Butantan Quadrivalent Influenza Vaccine

Double-blind, Randomized Clinical Trial With Active Controls to Assess Safety, Immunogenicity and Lot-to-lot Consistency of Inactivated Split-virion Quadrivalent Influenza Vaccine of Butantan Institute

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 5,822 (actual)
• Sponsor: Butantan Institute · Other Government
• Sex: All
• Age: 3 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a double blinded, randomized active-control comparator study to assess the safety and immunogenicity of QIV-IB, the Butantan Institute quadrivalent influenza vaccine candidate. As active controls, two trivalent influenza vaccines with different Influenza B strains, one with influenza B/Victoria strain (TIVV-IB) and other with influenza B/Yamagata strain (TIVY-IB). The study is designed to build a safety database of the quadrivalent influenza vaccine in adults to detect adverse events with a frequency of 1:1000 or higher and safety databases for elderly and pediatric age groups to detect adverse events with frequency of 1:100 or higher. In terms of immune response, the study aims to demonstrate superiority of HI (Hemagglutinin inhibition) GMT (Geometric Mean Titer) of the QIV-IB for the Influenza B strain that is not present in each trivalent vaccine control. Regarding the Influenza A and B strains common to QIV-IB and both trivalent vaccine controls, the study aims to demonstrate non-inferiority on those strains. Finally, a lot-to-lot consistency test will be performed in a sub-group of adult participants.

Conditions

• Influenza, Human

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-05-12
• Primary completion: 2023-10-13
• Completion: 2024-03-13
• First posted: 2019-04-25
• Last updated: 2025-02-21

Locations

12 sites across 1 country: Brazil