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

This study has been completed.

First Received: April 3, 2006 Last Updated: September 13, 2006 History of Changes

Sponsors and Collaborators:	Novartis Novartis Vaccines Chiron s.r.l. Beijing Representative Office
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00310648

Purpose

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.

Condition	Intervention	Phase
Influenza	Biological: Influenza vaccine	Phase III

MedlinePlus related topics: Flu

Drug Information available for: Fluvirin Influenza Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Part 1:Phase I Open-Label, Single-Center to Evaluate the Safety of a Commercially Available 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 a Commercially Available Influenza Vaccine and a Conventional Commercially Available Influenza Vaccine When Administered to Elderly Subjects

Further study details as provided by Novartis:

Primary Outcome Measures:

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:

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

Estimated Enrollment:	600
Study Start Date:	January 2006

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both

Criteria

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00310648

Locations

China
Nanning
Guangxi, China, 530021

Sponsors and Collaborators

Novartis

Novartis Vaccines

Chiron s.r.l. Beijing Representative Office

Investigators

Study Director:

Novartis Vaccines - Drug Information Services

Novartis Vaccines & Diagnostics

More Information

No publications provided

Study ID Numbers:	M70P1, Part 1: 200511-I, Part 2: 200511-III
Study First Received:	April 3, 2006
Last Updated:	September 13, 2006
ClinicalTrials.gov Identifier:	NCT00310648 History of Changes
Health Authority:	China: State Food and Drug Administration

Keywords provided by Novartis:

Influenza, elderly, vaccine

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

Additional relevant MeSH terms:

Virus Diseases
RNA Virus Infections
Respiratory Tract Diseases

Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

ClinicalTrials.gov processed this record on May 07, 2009