We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00310648
First Posted: April 4, 2006
Last Update Posted: September 14, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Novartis Vaccines
Chiron s.r.l. Beijing Representative Office
Information provided by:
Novartis
April 3, 2006
April 4, 2006
September 14, 2006
January 2006
Not Provided
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.
Not Provided
Complete list of historical versions of study NCT00310648 on ClinicalTrials.gov Archive Site
Solicited Local and Systemic Reactions Within 6 Days Following Vaccination And Adverse Events Thought the Study.
Not Provided
Not Provided
Not Provided
 
Comparative Trial Evaluating Safety and Immunogenicity of an Adjuvanted and a Conventional Influenza Vaccine in Elderly Subjects (> 60 Years)
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Influenza
Biological: Influenza vaccine
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
600
Not Provided
Not Provided

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).
Sexes Eligible for Study: All
60 Years and older   (Adult, Senior)
Not Provided
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT00310648
M70P1
Part 1: 200511-I
Part 2: 200511-III
Not Provided
Not Provided
Not Provided
Not Provided
Novartis
  • Novartis Vaccines
  • Chiron s.r.l. Beijing Representative Office
Study Director: Novartis Vaccines - Drug Information Services Novartis Vaccines & Diagnostics
Novartis
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP