drugset / Trial / 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

NCT01701752 ↗

Phase 1 Completed 120 enrolled Immune Targeting Systems Ltd
RandomizedParallel-groupTriple-blindPrevention

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Comparator FP-01.1 Peptide — —
Comparator FP-01.1-Adjuvant Vaccine — —
Comparator Trivalent Inactivated Influenza Virus Vaccine — —

Indications