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Immunogenicity of a Surface Antigen, Inactivated Influenza Vaccine Formulation 2007-2008

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00518453
First Posted: August 20, 2007
Last Update Posted: December 1, 2016
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.
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
August 17, 2007
August 20, 2007
December 1, 2016
July 2007
August 2007   (Final data collection date for primary outcome measure)
evaluate the antibody response to each influenza vaccine antigen [ Time Frame: 21 days post-immunization ]
evaluate the antibody response to each influenza vaccine antigen at 21 days post-immunization
Complete list of historical versions of study NCT00518453 on ClinicalTrials.gov Archive Site
Safety and tolerability of the study vaccine in the study population [ Time Frame: Throughout the study ]
Safety of a single intramuscolar injection
Not Provided
Not Provided
 
Immunogenicity of a Surface Antigen, Inactivated Influenza Vaccine Formulation 2007-2008
A Phase II, Open-Label, Uncontrolled, Single Center Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated Influenza Vaccine Ph.Eur, Formulation 2007-2008, When Administered to Non-Elderly Adult and Elderly Subjects
Due to antigenic changes of influenza viruses, the virus strains used in influenza vaccines are adjusted every year according to WHO and CPMP recommendations. Immunogenicity and tolerability of the newly composed vaccines are subject for evaluation in a yearly clinical trial in non-elderly adults and elderly subjects (CPMP/BWP/214/96).
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Influenza
Biological: Surface antigen inactivated influenza vaccine
1 dose of Fluvirin 2007/2008 Northern Hemisphere vaccine composition
Experimental: Arm 1: Fluvirin
Intervention: Biological: Surface antigen inactivated influenza vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
129
August 2007
August 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy Subjects eligible for enrollment into this study are male and female adult volunteers

Exclusion Criteria:

  • Any serious disease
Sexes Eligible for Study: All
18 Years to 84 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT00518453
V78P5S
2007-002063-27
No
Not Provided
Not Provided
Novartis ( Novartis Vaccines )
Novartis Vaccines
Not Provided
Study Chair: Novartis Vaccines Novartis Vaccines
Novartis
November 2011

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