NCT03330899

Safety and Immunogencity of H7N9 Influenza Antigen With 2 Adjuvant Formulations in Healthy Adults in Brazil

A Phase I Randomized, Double-blind, Placebo-controlled, Dose Finding Clinical Trial to Evaluate the Safety and Immunogencity of H7N9 Influenza Antigen Adjuvanted With 2 Different Adjuvant Formulations in Healthy Adult Volunteers in Brazil

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 432 (actual)
• Sponsor: Butantan Institute · Other Government
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

Summary

The overall aim of this study is to evaluate the safety, immunogenicity and dose sparing effects of H7N9 influenza antigen formulated with 2 different adjuvants .

Detailed description

Following the emergence of avian influenza A/H7N9 influenza virus in humans in China in March 2013, the WHO Essential Regulatory Laboratories prepared candidate vaccine viruses and reagents for further development and several manufacturers have developed various inactivated influenza vaccines with and without adjuvant against A/H7N9 and tested these candidates in trials in healthy adults. The overall aim of this study is to evaluate the safety, immunogenicity and dose sparing effects of H7N9 influenza antigen produced by Butantan Institute in combination with 2 different adjuvants.

Conditions

• Influenza
• H7N9 Influenza

Interventions

Type	Name	Description
BIOLOGICAL	H7N9 antigen + adjuvant IB160	H7N9 monovalent (fragmented and inactivated)
BIOLOGICAL	H7N9 antigen + adjuvant SE	H7N9 monovalent (fragmented and inactivated)
BIOLOGICAL	H7N9 antigen without adjuvant	H7N9 monovalent (fragmented and inactivated)
BIOLOGICAL	Placebo (PBS)	Placebo (Phosphate Buffered Saline -PBS)

Timeline

• Start date: 2018-09-24
• Primary completion: 2020-01-30
• Completion: 2020-08-25
• First posted: 2017-11-06
• Last updated: 2020-09-30

Locations

3 sites across 1 country: Brazil