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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01152814
First received: June 28, 2010
Last updated: January 23, 2012
Last verified: January 2012
  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 flu 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 2010-2011, When Administered to Elderly Subjects

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Antibody response to each influenza vaccine antigen [ Time Frame: 22 days, including the 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:
  • Safety of a single IM injection of trivalent subunit inactivated flu vaccine [ 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: 64
Study Start Date: June 2010
Study Completion Date: July 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
No comparator is administered, only one IM single dose of trivalent subunit inactivated influenza vaccine is administered during the vaccination visit
Biological: Seasonal flu vaccine
This phase II is performed as a multicenters study site 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: till day 22)

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01152814

Locations
Italy
Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio, Via dei Vestini
Chieti, Italy, 66100
Dipartimento di Medicina Clinica e Sperimentale - Sezione di Igiene e Medicina Preventiva, Via Fossato di Mortara, 64/b
Ferrara, Italy, 44100
Dipartimento di Scienze della Salute Università di Genova Via Pastore, 1
Genova, Italy, 16132
Centro Satellite. ASL Lanciano - Vasto, sede legale Via S. Spaventa, 37
Lanciano, Italy, 66034
Centro Satellite. Distretto Sanitario di Base di Fossacesia in Via Polidoro-Vasto
Lanciano, Italy
Vaccine and Immunotherapy Research Center Department of Infectious and Tropical Diseases San Raffaele Scientific Institute Via Stamira d'Ancona, 20
Milano, Italy, 20127
Sponsors and Collaborators
Novartis Vaccines
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01152814     History of Changes
Other Study ID Numbers: V70_25S, 2010-018603-29
Study First Received: June 28, 2010
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
Respiratory Tract Diseases
Respiratory Tract Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 29, 2014