Safety and Immunogenicity of Trivalent Split 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:
NCT00735410
First received: August 13, 2008
Last updated: November 4, 2011
Last verified: November 2011
  Purpose

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


Condition Intervention Phase
Seasonal Influenza, Vaccine
Biological: Seasonal 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 Preservative Free, Inactivated Split Influenza Vaccine, Using the Strain Composition 2008/2009 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: No ]

Secondary Outcome Measures:
  • Evaluation of safety of the influenza vaccine [ Time Frame: 21 days (-1/+7) ] [ Designated as safety issue: Yes ]

Enrollment: 134
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
Experimental: 1 Biological: Seasonal Influenza Vaccine
1 dose of Split influenza vaccine

  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, mentally competent, willing and able to give informed consent prior to study entry
  • available for all the visits scheduled in the study and able to comply with all study requirements
  • in good health as determined by: medical history physical examination clinical judgment of the investigator

Exclusion Criteria:

  • They Have any serious (in the judgment of the investigator) disease, 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

  • They have a 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).
  • 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.

  • Known or suspected history of drug or alcohol abuse.
  • 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;
  • Women who are pregnant or woman of childbearing potential unwilling to practice acceptable contraception for the duration of the study (21 days).
  • Influenza vaccination or laboratory confirmed influenza within the last 6 months and more than one influenza vaccination within the past 12 months
  • Within the past 4 weeks they have received:

another vaccine any investigational agent;

  • 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
  • Simultaneous participation in another clinical study.
  • Any condition, which, in the opinion of the investigator, might prevent the subject from participation or interfere with the evaluation of the study objectives.
  • Severely obese with Body Mass Index (BMI) > 35
  • 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: NCT00735410

Locations
Germany
Site 1, 2 and 3
Hessen, Germany, 35033
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: NCT00735410     History of Changes
Other Study ID Numbers: V44P12S, 2008-000887-18
Study First Received: August 13, 2008
Last Updated: November 4, 2011
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Novartis:
Influenza vaccine
Seasonal
Split

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 19, 2014