NCT03777163

Safety and Immunogenicity of the Butantan Institute Influenza Vaccine Compared to Sanofi Pasteur Influenza Vaccine

Safety and Immunogenicity of the Butantan Institute Trivalent Seasonal Influenza Vaccine in Comparison With the Sanofi Pasteur Trivalent Seasonal Influenza Vaccine in Brazilian Subjects.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 632 (actual)
• Sponsor: Butantan Institute · Other Government
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Accepted

Summary

The overall aim of this study is to evaluate the safety and immunogenicity of Butantan Institute Trivalent Seasonal Influenza Vaccine in comparison with the Sanofi Trivalent Seasonal Influenza Vaccine.

Detailed description

To detemine whether immunogenicity elicited by a single-dose Butantan Institute Trivalent Seasonal Influenza Vaccine is not inferior to that elicited by a single dose of Sanofi Trivalent Seasonal Influenza Vaccine in adult and elderly populations measured by HI GMT for the three vaccine components 21 days post-immunization. To describe the safety profile of Butantan Institute Trivalent Seasonal Influenza Vaccine and Sanofi Trivalent Seasonal Influenza Vaccine after a single dose in adult and elderly populations.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Butantan Institute Trivalent Seasonal Influenza Vaccine	Butantan Institute and Pasteur-Mérieux (present, Sanofi Pasteur) established a technology transfer in 1999 for the production of a trivalent influenza vaccine of inactivated split-virion using embryonated eggs. The technology transfer followed a progressive approach from importing the finished product, to packaging and quality control test for release (1999), and, finally, to the first batch of influenza vaccine entirely produced by Butantan (2011). In 2013, the Butantan vaccine was registered by the Brazilian National Agency of Sanitary Surveillance (ANVISA).
BIOLOGICAL	Sanofi Trivalent Seasonal Influenza Vaccine	VAXIGRIP® was launched in 1968 and since then has been licensed in more than 100 countries and prequalified by WHO in 2011. Several clinical studies by Sanofi Pasteur have examined the safety and immunogenicity of Vaxigrip® in older children (8-10 years), adults (18-59 years), elderly (\> 60 years),11,12 children (six months to three years) 13 and pregnant women.

Timeline

• Start date: 2019-04-22
• Primary completion: 2020-01-15
• Completion: 2020-03-30
• First posted: 2018-12-17
• Last updated: 2024-02-15

Locations

4 sites across 1 country: Brazil