Comparative Trial Evaluating Safety and Immunogenicity of an Adjuvanted and a Conventional Influenza Vaccine in Elderly Subjects (> 60 Years)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
|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|
- 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.
- Solicited Local and Systemic Reactions Within 6 Days Following Vaccination And Adverse Events Thought the Study.
|Study Start Date:||January 2006|
|Guangxi, China, 530021|
|Study Director:||Novartis Vaccines - Drug Information Services||Novartis Vaccines & Diagnostics|