Study to Evaluate Safety and Immunogenicity of Sub-unit Adjuvanted Influenza Vaccine Administered to Elderly Subjects - Full Text View

Purpose

This study will evaluate the safety and immunogenicity of a sub-unit, adjuvanted Influenza Vaccine Administered to Elderly Subjects.

Condition	Intervention	Phase
Seasonal Influenza	Biological: Seasonal Influenza Vaccine	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: 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, Adjuvanted With MF59C.1 Influenza Vaccine, Formulation 2011-2012, When Administered to Elderly Subjects

Resource links provided by NLM:

MedlinePlus related topics: Flu

Drug Information available for: Influenza Vaccines

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

To evaluate the antibody response to each influenza vaccine antigen at 21 days post-immunization in elderly subjects [ 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.

Secondary Outcome Measures:

To evaluate the safety of a single IM injection of trivalent subunit inactivated influenza vaccine in elderly subjects. [ Time Frame: 22 days, including the follow up period ] [ Designated as safety issue: Yes ]
- Safety will be assessed in accordance with available safety data on influenza vaccines:
- Local and systemic reactions will be assessed for 3 days post the day of vaccination
- AEs Days 1 to 4. All AEs necessitating a physician's visit or consultation and/or leading to premature study discontinuation and all SAEs until Day 22 of until resolution.

Enrollment:	63
Study Start Date:	May 2011
Study Completion Date:	June 2011
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Sub unit, Inactivated, MF59C.1 Adjuvanted Influenza Vaccine 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 elderly subjects. Enrolled subjects received one single IM dose of trivalent subunit inactivated adjuvanted flu vaccine during the vaccination visit, according to the study protocol (follow-up period: until day 22) .

Eligibility

Criteria

Inclusion Criteria:

Males and females volunteers of 65 years of age or older, mentally competent, willing and able to give written informed consent prior to study entry.
Individuals able to complain with all the study requirements.
Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
Written informed consent must be obtained for all the subjects before enrollment into the study after the nature of the study has been explained.

Exclusion Criteria:

Individuals with any serious chronic or acute disease.
Individuals with history of any anaphylactic reaction and/or serious allergic reaction following a vaccination.
Individuals with known or suspected impairment/alteration of immune function.
Individuals with known or suspected history of drug or alcohol abuse.
Individuals with a bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject.
Individuals within the past 6 months, they have: had any seasonal and pandemic laboratory confirmed influenza disease; received any seasonal and pandemic influenza vaccine.
Individuals with any acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the last 7 days.
Individuals that have experienced fever (i.e., axillary temperature ≥38°C) within the last 3 days of intended study vaccination.
Individuals participating in any clinical trial with another investigational product 4 weeks prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study.
Individuals who received any other vaccines within 4 weeks prior to enrollment in this study or who are planning to receive any vaccine within 4 weeks from the study vaccines.
Individuals who are part of study personnel or close family members conducting this study.
BMI > 35 kg/m2.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01344057

Locations

Italy
Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio
Via dei Vestini, Chieti, Italy, 66100
Department of "Scienze della Salute" University of Genova Via Pastore 1
Genova, Italy, 16132
Vaccine and Immunotherapy Research Center Department of Infectious and Tropical Diseases San Raffaele Scientific Institute Via Stamira d'Ancona 20
Milano, Italy, 20127
Department of "malattie infettive" Ospedale San Gerardo, via Pergolesi 33
Monza, Italy, 20052

Sponsors and Collaborators

Novartis Vaccines

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:	NCT01344057 History of Changes
Other Study ID Numbers:	V70_32S, 2010-021841-38
Study First Received:	April 21, 2011
Last Updated:	January 23, 2012
Health Authority:	European Union: European Medicines Agency

Keywords provided by Novartis:

Seasonal Influenza, vaccine

Additional relevant MeSH terms:

Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections

Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013