A Phase Ib, Multi-Center, Randomized, Observer-Blind, Proof of Concept, Dose- and Formulation-Ranging Study to Evaluate Safety, Tolerability, and Immunogenicity of One Dose of Trivalent Inactivated Influenza Vaccine in Different Presentations (Intramuscular and Intradermal Delivery), Dosages (Regular or Higher A/H3N2 Content) and Doses of Adjuvant Administered to Healthy Elderly Aged ≥ 65 Years

Seqirus1 site in 1 country450 target enrollmentOctober 2008

ConditionsInfluenza

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Influenza
Sponsor: Seqirus
Enrollment: 450
Locations: 1
Primary Endpoint: Assessment of all adverse events from time of vaccination through study end will be collected to for safety assessment.
Status: Completed
Last Updated: 9 years ago

The study will evaluate the safety, tolerability and immunogenicity of different doses and types of Influenza Vaccine in healthy elderly subjects.

Registry

clinicaltrials.gov

Start Date

October 2008

End Date

April 2009

Last Updated

9 years ago

Study Type

Interventional

Study Design

Factorial

Sex

All

Sponsor

Seqirus

Responsible Party

Sponsor

•Subjects 65 years or older generally in good health as determined by medical history, physical assessment and clinical judgment of the investigator.

•Subjects who have received influenza vaccine within the past 6 month and who have received adjuvanted vaccine in the past two years.
•Subjects with hypersensitivity to vaccine components. Subjects who are on or were recently on immunosuppressive therapy.