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

Phase 3

Completed

• Conditions: Influenza

• Registration Number: NCT00310648
• Lead Sponsor: Novartis

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-04-03
• Study First Submitted QC: 2006-04-03
• Study First Posted: 2006-04-04
• Status Verified: 2006-09
• Last Update Submitted: 2006-09-13
• Last Update Posted: 2006-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

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

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Requirements For Drug Registration & Guide Principles For ClinicaL Trial Techniques of Vaccine e.g Seroprotection, GMR's and Seroconversion rate at day 21 following vaccination.

Secondary Outcome Measures

Name	Time	Method
Solicited Local and Systemic Reactions Within 6 Days Following Vaccination And Adverse Events Thought the Study.

Trial Locations

Locations (1)

Nanning; 🇨🇳 Guangxi, China