Safety and Immunogenicity of Surface Antigen, Inactivated, Influenza Vaccine Using the Strain Composition 2009/2010 Recommended in Northern Hemisphere in Non-elderly Adult and in Elderly Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00918268
First received: June 9, 2009
Last updated: April 20, 2012
Last verified: April 2012
  Purpose

Annual trial for registration influenza vaccine with the strain composition for season 2009/2010.


Condition Intervention Phase
Influenza Disease
Biological: Influenza vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy 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 Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2009-2010, When Administered to Non-elderly Adult and Elderly Subjects

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Evaluation of the antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) at 21 days post-immunization in non-elderly adult and elderly subjects [ Time Frame: 21(-1/+5) days ] [ Designated as safety issue: Yes ]
  • Evaluation of safety of a single intramuscular injection of influenza vaccine in non elderly adult and elderly subjects [ Time Frame: 21(-1/+5) days ] [ Designated as safety issue: Yes ]

Enrollment: 130
Study Start Date: June 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Influenza vaccine Biological: Influenza vaccine
One 0.5mL dose of Inactivated, Influenza Vaccine using the strain composition 2009/2010

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 years of age or older, mentally competent, willing and able to give written informed consent prior to study entry;
  • able to comply with all the study requirements;
  • in general good health as determined by: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:

  • They have any serious chronic or acute disease (in the judgment of the investigator) including but not limited to:

    1. Cancer, except for localized skin cancer;
    2. Advanced congestive heart failure
    3. Chronic obstructive pulmonary disease (COPD);
    4. Autoimmune disease (including rheumatoid arthritis);
    5. Acute or progressive hepatic disease;
    6. Acute or progressive renal disease;
    7. Severe neurological or psychiatric disorder
    8. Severe asthma
  • They have history of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine (e.g., to ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate);
  • They have a known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age) resulting, for example, from:- receipt of immunosuppressive therapy (any parenteral or oral corticosteroid or cancer chemotherapy/radiotherapy) within the past 60 days and for the full length of the study;receipt of immunostimulants,receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months and for the full length of the study and suspected or known HIV infection or HIV-related disease;
  • They have a known or suspected history of drug or alcohol abuse;
  • They have a bleeding diathesis or condition associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject;
  • Female who are pregnant or nursing (breastfeeding) mothers or females of childbearing age do not plan to use acceptable birth control measures, for the duration of the study. Adequate contraception is defined as hormonal (e.g., oral, injection, transdermal patch, implant, cervical ring), barrier (e.g., condom or diaphragm), intrauterine device (IUD), or monogamous relationship with vasectomized partner who has been vasectomized for 6 months or more prior to the subject's study entry;
  • Within the past 12 months, they have:- received more than one injection of influenza vaccine
  • Within the past 6 months, they have:-had laboratory confirmed influenza disease,- received influenza vaccine;
  • Within the past 4 weeks they have received:-another vaccine;-any investigational agent;
  • They have any acute or chronic infection requiring systemic antibiotic treatment or antiviral therapy within the last 7 days;
  • They have experienced fever (i.e., axillary temperature≥ 38°C) within the last 3 days;
  • They are taking part in another clinical study;
  • They have any condition which, in the opinion of the investigator,might interfere with the evaluation of the study objectives;
  • They are severely obese with Body Mass Index (BMI) > 35;
  • Site personnel involved in the evaluation of safety and their immediate relatives are excluded from participation.
  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: NCT00918268

Locations
Italy
Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio, Via dei Vestini
Chieti, Italy, 66100
Ufficio Igiene e Sanità Pubblica di Lanciano, ASL Lanciano - Vasto, sede legale Via S. Spaventa, 37 ----- Satellite sites: (a) Distretto Sanitario di Base, Via Don Minzoni, Lanciano (CH) and (b) Distretto Sanitario di Base, Via Polidoro, Fossacesia (CH))
Lanciano, Italy, 66034
Pianiga Distretto n. 2 - Area Sud - Azienda ULSS 13 Mirano-Via Nazionale 48
Pianiga, Italy, 30030
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines Novartis Vaccines
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00918268     History of Changes
Other Study ID Numbers: V71_10S, 2009−010598−19
Study First Received: June 9, 2009
Last Updated: April 20, 2012
Health Authority: Italy: Ethics Committee delegated by AIFA

Keywords provided by Novartis:
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 August 20, 2014