Safety and Immunogenicity, Inactivated Split Influenza Vaccine, Using the Strain Composition 2009/2010

This study has been completed.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00945841
First received: July 22, 2009
Last updated: July 23, 2009
Last verified: July 2009
  Purpose

This study is an annual trial for registration of inactivated split influenza vaccine with strain composition for season 2009/2010.


Condition Intervention Phase
Seasonal Influenza
Biological: inactivated split influenza vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase III, Multicenter, Uncontrolled, Open-label Study to Evaluate Safety and Immunogenicity of a Preservative Free, Inactivated Split Influenza Vaccine, Using the Strain Composition 2009/2010 When Administered to Adult and Elderly Subjects

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 haemagglutination inhibition (HI) test on Day 0 and on Day 21 [ Time Frame: 21 days (-1/+7) ] [ Designated as safety issue: Yes ]
  • Evaluation of safety of inactivated split influenza vaccine [ Time Frame: 21 days (-1/+7) ] [ Designated as safety issue: Yes ]

Enrollment: 126
Study Start Date: June 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Biological: inactivated split influenza vaccine
1 dose of inactivated split 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:

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. 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:

Subjects are not to be enrolled into the study if at least one of the following criteria is fulfilled:

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

    • Cancer, except for localized skin cancer;
    • Advanced congestive heart failure;
    • Chronic obstructive pulmonary disease (COPD);
    • Autoimmune disease (including rheumatoid arthritis);
    • Acute or progressive hepatic disease;
    • Acute or progressive renal disease;
    • Severe neurological or psychiatric disorder;
    • Severe Asthma.
  2. 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 neomycin or polymyxin).
  3. 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 parental or oral cortical steroid 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 derivatives within the past 3 months and for the full length of the study.
    • Suspected or known HIV infection or HIV-related disease.
  4. Known or suspected history of drug or alcohol abuse.
  5. They have a bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject;
  6. Women who are pregnant or woman of childbearing potential unwilling to practice acceptable contraception for the duration of the study (21 days). Female who pregnant of nursing (breastfeeding) mothers of females of childbearing age who do not plan to use acceptable birth control measures, for the duration of the study. Adequate contraception is defined as hormonal (oral, injection, transdermal patch, implant, cervical ring), barrier (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.
  7. Influenza vaccination or laboratory confirmed influenza within the last 6 months and more than one influenza vaccination within the past 12 months.
  8. Within the past 4 weeks they have received:

    • Another vaccine;
    • Any investigational agent.
  9. Any acute or chronic infection requiring systemic antibiotic treatment or antiviral therapy within the last 7 days.
  10. They have experienced fever (i.e., axillary temperature ≥ 38°C) within the last 3 days.
  11. Simultaneous participation in another clinical study.
  12. Any condition, which, in the opinion of the investigator, might prevent the subject from participation or interfere with the evaluation of the study objectives.
  13. Severely obese with Body Mass Index (BMI) > 35.
  14. Site personnel involved in 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: NCT00945841

Locations
Germany
Site 2
Giessen, Germany, 35392
Site 1
Herborn, Germany, 35745
Site 3
Marburg, Germany, 35033
Sponsors and Collaborators
Novartis
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines Novartis Vaccines
  More Information

No publications provided

Responsible Party: Novartis, Novartis Vaccines
ClinicalTrials.gov Identifier: NCT00945841     History of Changes
Other Study ID Numbers: V44_13S, 2009-010565-23
Study First Received: July 22, 2009
Last Updated: July 23, 2009
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Novartis:
influenza vaccine
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 October 16, 2014