NCT01701752

Influenza A Vaccine (FP-01.1) Formulated With and Without Adjuvant, in the Presence or Absence of a Single Administration of a Trivalent Inactivated Influenza Virus Vaccine in Older Adults

A Randomised, Double Blind, Double Observer Study to Assess Repeated Administration of a Single Dose of an Influenza A Vaccine (FP-01.1) Formulated With and Without Adjuvant, in the Presence or Absence of a Single Dose of a Trivalent Inactivated Influenza Virus Vaccine in Subjects 65 to 74 Years of Age.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Immune Targeting Systems Ltd · Industry
• Sex: All
• Age: 65 Years – 74 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the safety and immunogenicity of FP-01.1 and FP-01.1 reformulated with an adjuvant (FP-01.1-Adjuvant) in relatively healthy subjects 65 to 74 years of age, subjects that are more representative of the target population. Both formulations will be administered alone or concomitantly with the Trivalent Inactivated Influenza Virus (TIV) vaccine.

Conditions

• Influenza A

Interventions

Type	Name	Description
BIOLOGICAL	FP-01.1 + Placebo
BIOLOGICAL	FP-01.1 + TIV
BIOLOGICAL	FP-01.1-Adjuvant + Placebo
BIOLOGICAL	FP-01.1-Adjuvant + TIV
BIOLOGICAL	Adjuvant + TIV
BIOLOGICAL	Placebo + TIV
BIOLOGICAL	FP-01.1
BIOLOGICAL	FP-01.1-Adjuvant
OTHER	Placebo

Timeline

• Start date: 2012-09-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2012-10-05
• Last updated: 2013-07-29