Comparative Trial Evaluating Safety and Immunogenicity of an Adjuvanted and a Conventional Influenza Vaccine in Elderly Subjects (> 60 Years)
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|ClinicalTrials.gov Identifier: NCT00310648|
Recruitment Status : Completed
First Posted : April 4, 2006
Last Update Posted : September 14, 2006
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 or disease||Intervention/treatment||Phase|
|Influenza||Biological: Influenza vaccine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|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 Start Date :||January 2006|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00310648
|Guangxi, China, 530021|
|Study Director:||Novartis Vaccines - Drug Information Services||Novartis Vaccines & Diagnostics|