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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

NCT01701752 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2013-07-29

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Immune Targeting Systems Ltd

    lead INDUSTRY

Principal Investigators

  • Geert Leroux-Roels, Professor · Centre for Vaccinology, Ghent University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2013-04-30
Completion
2013-04-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01701752 on ClinicalTrials.gov