Comparative Trial Evaluating Safety and Immunogenicity of an Adjuvanted and a Conventional Influenza Vaccine in Elderly Subjects (> 60 Years)

Novartis

Status and phase

Completed

Phase 3

Conditions

Influenza

Treatments

Biological: Influenza vaccine

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT00310648

Part 2: 200511-III

Part 1: 200511-I

M70P1

Details and patient eligibility

About

Clinical Trial in Two parts:

Part 1: Phase I, Open-Label, Single-Center Study to Evaluate the Safety of an adjuvanted Influenza Vaccine When Administered to Elderly Subjects.

Part 2: A Phase III, Randomized, Controlled, Observer-blind, Single-Center Study to Evaluate the Immunogenicity and Safety of an adjuvanted and a conventional Influenza Vaccine When Administered to Elderly Subjects.

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects 60 years of age or older, mentally competent, willing and able to give the written informed consent prior to study entry

Exclusion criteria

Any serious disease such as: cancer, autoimmune disease, advanced arteriosclerotic disease or complicated diabetes mellitus, chronic obstructive pulmonary disease (COPD) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure.
Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine.
History of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine.
Known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age).