Safety and Immunogenicity of Surface Antigen, Inactivated, Influenza Vaccine Using the Strain Composition 2008/2009

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00748813
First received: September 8, 2008
Last updated: December 7, 2011
Last verified: December 2011
  Purpose

Annual trial for registration influenza vaccine with the strain composition for season 2008/2009


Condition Intervention Phase
Seasonal Influenza
Biological: Influenza Vaccine, Formulation 2008-2009
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 2008-2009, When Administered to Non-Elderly Adult and Elderly Sub

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Evaluation of antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) test on Day 0 and on Day 21 [ Time Frame: 21 days (-1/+5) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of safety [ Time Frame: 21 days (-1/+5) ] [ Designated as safety issue: Yes ]

Enrollment: 133
Study Start Date: June 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Biological: Influenza Vaccine, Formulation 2008-2009
1 dose of Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2008-2009

  Eligibility

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

Inclusion Criteria:

  • Subjects eligible for enrollment into this study are male and female adults who are:

    1. ≥ 18 years of age, mentally competent, willing and able to give informed consent prior to study entry
    2. able to comply with all study requirements
    3. in good health as determined by:
  • medical history
  • physical examination
  • clinical judgment of the investigator

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;
  • 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;
  • Women who are pregnant, or women able to bear children but not willing to practice acceptable contraception for the duration of the trial (21 days);
  • 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; 1 - They have experienced an acute exacerbation of a COPD within the past 14 days
  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: NCT00748813

Locations
Italy
Site 1
Chieti, Italy, 66100
Site 2
Lanciano, Italy, 66034
Site 3
Pianiga, Italy, 30034
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: NCT00748813     History of Changes
Other Study ID Numbers: V71P7S, 2008-001079-31
Study First Received: September 8, 2008
Last Updated: December 7, 2011
Health Authority: Italy: Ministero della Salute, EMEA

Keywords provided by Novartis:
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 23, 2014