NCT02126761

Safety and Immunogenicity of Different Formulations of an Adjuvanted, Trivalent Subunit Influenza Vaccine in Elderly Subjects 65 Years of Age and Above

A Phase 1, Randomized, Observer Blind, Antigen and Adjuvant Dosage-Finding Study to Evaluate the Safety and Immunogenicity of an Adjuvanted, Trivalent Subunit Influenza Vaccine in Elderly Subjects ≥65 Years of Age

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 196 (actual)
• Sponsor: Seqirus · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

In this study, the safety and immunogenicity of the current formulation of aTIV will be compared to aTIV-modified formulations in which the dosage of the MF59 adjuvant will be doubled or tripled and/or the dosage of the 3 influenza virus strains will be doubled, in independently-living elderly subjects ≥ 65 years of age.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Adjuvanted, trivalent subunit influenza vaccine	Group 1 and group 5 are active comparators; group 5 includes placebo comparator as a second injection in contralateral deltoid
BIOLOGICAL	Adjuvant level modified adjuvanted, trivalent subunit influenza vaccine	Group 2 and group 6 are experimental; group 2 has double dosage of MF59 in a single injection; group 6 has triple dosage of MF59 and includes placebo comparator in contralateral deltoid
BIOLOGICAL	Antigen level modified adjuvanted, trivalent subunit influenza vaccine	Group 3 is experimental with double the usual antigen dosage
BIOLOGICAL	Antigen and adjuvant level modified adjuvanted, trivalent subunit influenza vaccine	Group 4 and 7 are experimental; group 4 has one injection with double the antigen and adjuvant; group 7 has two injections with double the antigen and adjuvant

Timeline

• Start date: 2014-06-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2014-04-30
• Last updated: 2016-07-29

Locations

1 site across 1 country: Germany