Back to resultsComparative Trial Evaluating Safety and Immunogenicity of an Adjuvanted and a Conventional Influenza Vaccine in Elderly Subjects (> 60 Years)
Primary Purpose
Influenza
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Influenza vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Influenza, elderly, vaccine
Eligibility 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).
Sites / Locations
- Nanning
Outcomes
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.
Full Information
NCT ID
NCT00310648
First Posted
April 3, 2006
Last Updated
September 13, 2006
Sponsor
Novartis
Collaborators
Novartis Vaccines, Chiron s.r.l. Beijing Representative Office
1. Study Identification
Unique Protocol Identification Number
NCT00310648
Brief Title
Comparative Trial Evaluating Safety and Immunogenicity of an Adjuvanted and a Conventional Influenza Vaccine in Elderly Subjects (> 60 Years)
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
Collaborators
Novartis Vaccines, Chiron s.r.l. Beijing Representative Office
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza, elderly, vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
600 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Influenza vaccine
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Solicited Local and Systemic Reactions Within 6 Days Following Vaccination And Adverse Events Thought the Study.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Vaccines - Drug Information Services
Organizational Affiliation
Novartis Vaccines & Diagnostics
Official's Role
Study Director
Facility Information:
Facility Name
Nanning
City
Guangxi
ZIP/Postal Code
530021
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
18289372
Citation
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.
Results Reference
derived
Learn more about this trial
Comparative Trial Evaluating Safety and Immunogenicity of an Adjuvanted and a Conventional Influenza Vaccine in Elderly Subjects (> 60 Years)
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