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

Sponsor
Novartis Vaccines (Industry)
Overall Status
Completed
CT.gov ID
NCT00748813
Collaborator
(none)
133
Enrollment
3
Locations
1
Arm
30
Duration (Days)
44.3
Patients Per Site
45
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Biological: Influenza Vaccine, Formulation 2008-2009
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
133 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (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
Study Start Date :
Jun 1, 2008
Actual Primary Completion Date :
Jul 1, 2008
Actual Study Completion Date :
Jul 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Other: 1

Biological: Influenza Vaccine, Formulation 2008-2009
1 dose of Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2008-2009

Outcome Measures

Primary Outcome Measures

  1. Evaluation of antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) test on Day 0 and on Day 21 [21 days (-1/+5)]

Secondary Outcome Measures

  1. Evaluation of safety [21 days (-1/+5)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Site 1 Chieti Italy 66100
2 Site 2 Lanciano Italy 66034
3 Site 3 Pianiga Italy 30034

Sponsors and Collaborators

  • Novartis Vaccines

Investigators

  • Study Chair: Novartis Vaccines, Novartis Vaccines

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Novartis Vaccines
ClinicalTrials.gov Identifier:
NCT00748813
Other Study ID Numbers:
  • V71P7S
  • 2008-001079-31
First Posted:
Sep 9, 2008
Last Update Posted:
Dec 1, 2016
Last Verified:
Dec 1, 2011
Keywords provided by Novartis Vaccines
Influenza vaccine
Additional relevant MeSH terms:
Influenza, Human

Study Results

No Results Posted as of Dec 1, 2016