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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

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.
ClinicalTrials.gov Identifier: NCT01357265
Recruitment Status : Completed
First Posted : May 20, 2011
Last Update Posted : December 7, 2011
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

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

Condition or disease Intervention/treatment Phase
Influenza Biological: Seasonal Influenza Vaccine Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : May 2011
Primary Completion Date : May 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arm Intervention/treatment
No comparator is administered, only one IM single dose of trivalent subunit inactivated influenza vaccine is administered during the vaccination visit
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) .

Primary Outcome Measures :
  1. 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 ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

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): NCT01357265

Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio
Via Dei Vestini, Cheiti, Italy, 66100
Dipartimento di Scienze della Salute Università di Genova
Via Pastore, Genova, Italy, 16132
Distretto Sanitario di Base di Fossacesia
Via Polidoro-Vasto, Lanciano, Italy
ASL Lanciano - Vasto,
Via S. Spaventa, Lanciano, Italy, 66034
Vaccine and Immunotherapy Research Center Department of Infectious and Tropical Diseases San Raffaele Scientific Institute
Via Stamira d'Ancona, Milano, Italy, 20127
Dipartimento di malattie infettive Ospedale San Gerardo
Via Pergolesi 33, Monza, Italy, 20052
Sponsors and Collaborators
Novartis Vaccines

Responsible Party: Novartis Vaccines
ClinicalTrials.gov Identifier: NCT01357265     History of Changes
Other Study ID Numbers: V71_27S
2010-024400-98 ( EudraCT Number )
First Posted: May 20, 2011    Key Record Dates
Last Update Posted: December 7, 2011
Last Verified: December 2011

Keywords provided by Novartis ( Novartis Vaccines ):
Seasonal Influenza

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs