Safety and Immunogenicity of Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur, Formulation 2008-2009, When Administered to Non-Elderly Adult and Elderly Subjects

January 4, 2012 updated by: Novartis Vaccines

A Phase II, Open-Label, Uncontrolled, Single Center Study to Evaluate Safety and Immunogenicity of Flu Vaccine Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur, Formulation 2008-2009, When Administered to Non-Elderly Adult and Elderly Subjects

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

At enrolment, subjects were stratified into two age strata (18 to 60 years, over 60 years). Total duration of the study is three weeks. Vaccinations were to be administered on day 1. Blood samples were collected at day 1 (baseline, before the vaccination) and at day 22 (three weeks after the vaccination). Sera were tested by Hemagglutination Inhibition (HI) assay. Safety was assessed until 3 weeks after the vaccination.

Study Type

Interventional

Enrollment (Actual)

143

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Suffolk
      • Heath Road, Woolpit, Bury St. Edmunds, Suffolk, United Kingdom, IP309QU
        • The Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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:

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

Exclusion Criteria:

  • Any serious (in the judgment of the investigator) disease 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 ovalbumin, chicken protein, chicken feathers, influenza viral protein, neomycin, polymixin)

  • 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 parenteral or oral corticosteroid 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.
  • The subject has 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 woman of child-bearing 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, the subject has received:

    1. another vaccine
    2. any investigational agent
  • Any acute or chronic infection requiring systemic antibiotic treatment or antiviral therapy within the last 7 days.
  • The subject has experienced an acute exacerbation of a COPD within the past 14 days
  • The subject has experienced fever (i.e. axillary temperature ³ 38.0°C) within the last 3 days
  • Severely obese with Body Mass Index (BMI) > 35 kg/m2
  • Any condition, which, in the opinion of the investigator, might prevent the subject from participation or interfere with the evaluation of the study objectives.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Biological: Flu Vaccine Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur, Formulation 2008-2009
1 dose, 0.5 mL of Flu Vaccine Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur, Formulation 2008-2009

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
21 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of safety of the influenza vaccine
Time Frame: 21 days
21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Vaccines

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

September 5, 2008

First Submitted That Met QC Criteria

September 5, 2008

First Posted (Estimate)

September 8, 2008

Study Record Updates

Last Update Posted (Estimate)

January 5, 2012

Last Update Submitted That Met QC Criteria

January 4, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V78P6S
  • 2008-000939-17

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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