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

NCT ID: NCT00310648

Last Updated: 2006-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Brief Summary

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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

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Conditions

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Influenza

Keywords

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Influenza, elderly, vaccine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Interventions

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Influenza vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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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).
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Vaccines

INDUSTRY

Sponsor Role collaborator

Chiron s.r.l. Beijing Representative Office

UNKNOWN

Sponsor Role collaborator

Novartis

INDUSTRY

Sponsor Role lead

Principal Investigators

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Novartis Vaccines - Drug Information Services

Role: STUDY_DIRECTOR

Novartis Vaccines & Diagnostics

Locations

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Nanning

Guangxi, , China

Site Status

Countries

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China

References

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Li R, Fang H, Li Y, Liu Y, Pellegrini M, Podda A. Safety and immunogenicity of an MF59-adjuvanted subunit influenza vaccine in elderly Chinese subjects. Immun Ageing. 2008 Feb 20;5:2. doi: 10.1186/1742-4933-5-2.

Reference Type DERIVED
PMID: 18289372 (View on PubMed)

Other Identifiers

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Part 1: 200511-I

Identifier Type: -

Identifier Source: secondary_id

Part 2: 200511-III

Identifier Type: -

Identifier Source: secondary_id

M70P1

Identifier Type: -

Identifier Source: org_study_id