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NCT01357265 Clinical Trial

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

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01357265
Other study ID # V71_27S
Secondary ID 2010-024400-98
Status Completed
Phase Phase 2
First received May 5, 2011
Last updated December 6, 2011
Start date May 2011
Est. completion date June 2011

Study information
Verified date December 2011
Source Novartis
Contact n/a
Is FDA regulated No
Health authority European Union: European Medicines Agency
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 125
Est. completion date June 2011
Est. primary completion date May 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

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) .

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

Sponsors (1)
Lead Sponsor Collaborator
Novartis Vaccines

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate the antibody response to each influenza vaccine antigen at 21 days post-immunization in adult and elderly 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. 22 days including follow-up period Yes
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