Safety and Immunogenicity of Influenza Vaccine (Surface Antigen, Inactivated) [Ph.Eur], Formulation 2009-2010, When Administered to Non-Elderly Adult and Elderly Subjects

This study has been completed.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00956449
First received: August 8, 2009
Last updated: August 10, 2009
Last verified: August 2009
  Purpose

The purpose of this study is to evaluate the antibody response to each of the three influenza vaccine strains included in the licensed seasonal flu vaccine, as measured by hemagglutination inhibition (HI) at 21 days post immunization in non−elderly and elderly subjects in compliance with the requirements of the current European Union (EU) recommendations for the evaluation of the immunogenicity for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96).


Condition Intervention Phase
Influenza
Seasonal Influenza
Biological: Seasonal Influenza Vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase II, Single Center, Uncontrolled, Open-Label Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated Influenza Vaccine [Ph.Eur], 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:
  • Immunogenicity and tolerability of the Flu vaccines is being measured [ Time Frame: 2 - 21 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate safety of a single IM (intramuscular) dose of the subunit vaccine of Influenza Vaccine Surface Antigen, Inactivated of Influenza Vaccine [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]

Enrollment: 126
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: 1 Biological: Seasonal Influenza Vaccine
1 dose of Influenza Vaccine Surface Antigen, Inactivated

  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:

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

      1. medical history,
      2. physical examination,
      3. clinical judgment of the investigator.

Exclusion Criteria:

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

    • 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
    • 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 eggs, 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:

      1. 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;
      2. Receipt of immunostimulants,
      3. Receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 3 months and for the full length of the study,
      4. 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). Females who are pregnant or nursing (breastfeeding) mothers or 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.
    • 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 or 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: NCT00956449

Locations
United Kingdom
The Health Centre
Suffolk, United Kingdom, IP309QU
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: NCT00956449     History of Changes
Other Study ID Numbers: V78_07S, 2009-011004-33
Study First Received: August 8, 2009
Last Updated: August 10, 2009
Health Authority: United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Keywords provided by Novartis:
flu
influenza
seasonal influenza
influenza vaccine antigen
immunogenicity
safety
tolerability
antibody response
intra muscular
elderly
non-elderly

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 01, 2014