Influenza Clinical Trial
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
Verified date | September 2006 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 600 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | |
Gender | Both |
Age group | 60 Years and older |
Eligibility |
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). |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
China | Nanning | Guangxi |
Lead Sponsor | Collaborator |
---|---|
Novartis | Chiron s.r.l. Beijing Representative Office, Novartis Vaccines |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Solicited Local and Systemic Reactions Within 6 Days Following Vaccination And Adverse Events Thought the Study. |
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