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Safety and Immunogenicity of One Dose of an Inactivated Trivalent Sub-unit Influenza Vaccine Administered to Non-elderly Adult and Elderly Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01357265
First received: May 5, 2011
Last updated: December 6, 2011
Last verified: December 2011

May 5, 2011
December 6, 2011
May 2011
May 2011   (final data collection date for primary outcome measure)
To evaluate the antibody response to each influenza vaccine antigen at 21 days post-immunization in adult and elderly [ Time Frame: 22 days including follow-up period ] [ Designated as safety issue: Yes ]
To evaluate the antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) and/or HI at 21 days post-immunization in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines.
Same as current
Complete list of historical versions of study NCT01357265 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety and Immunogenicity of One Dose of an Inactivated Trivalent Sub-unit Influenza Vaccine Administered to Non-elderly Adult and Elderly Subjects
A Phase II Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Surface, Antigen, Inactivated, Influenza Vaccine, Formulation 2011/2012, When Administered to Adult and Elderly Subjects

This study will evaluate safety and immunogenicity of a sub-unit Influenza vaccine when administered to adult and elderly subjects.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Influenza
Biological: Seasonal Influenza Vaccine
This phase II is performed as a multicenter study in adult and elderly subjects. Enrolled subjects received one single IM dose of trivalent subunit inactivated flu vaccine during the vaccination visit, according to the study protocol (follow-up period: until day 22) .
1
No comparator is administered, only one IM single dose of trivalent subunit inactivated influenza vaccine is administered during the vaccination visit
Intervention: Biological: Seasonal 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
125
June 2011
May 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

Healthy, adult and elderly volunteers over 18 years

Exclusion Criteria:

Individuals with any serious chronic or acute disease or known or suspected impairment of the immune system.

Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01357265
V71_27S, 2010-024400-98
Not Provided
Novartis ( Novartis Vaccines )
Novartis Vaccines
Not Provided
Not Provided
Novartis
December 2011

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