Status:
COMPLETED
Safety and Immunogenicity of One Dose of Seasonal Trivalent Influenza Virus Vaccine (TIVf, Purified Surface Antigen, Inactivated, Egg Derived) in Adults, Aged 18 Years and Above
Lead Sponsor:
Novartis Vaccines
Conditions:
Human Influenza
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The present study is designed to confirm the safety and immunogenicity of trivalent, surface antigen, inactivated influenza vaccine in 2 age cohorts: 18 to ≤60 years and ≥61 years and the antibody res...
Eligibility Criteria
Inclusion
- Male or female volunteer aged 18 years or older, mentally competent, who gave written informed consent prior to study entry;
- Able to comply with all the study requirements; and
- In good health as determined by the outcome of medical history, physical examination, and clinical judgment of the investigator
Exclusion
- Any behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may have interfered with the subject's ability to participate in the study;
- any serious chronic or acute disease (in the judgment of the investigator) including, but not limited to
- medically significant cancer (except for benign or localized skin cancer, cancer in remission for ≥10 years, or localized prostate cancer that has been clinically stable for \>2 years without treatment)
- medically significant advanced congestive heart failure (ie, New York Heart Association (NYHA) class III and IV)
- chronic obstructive pulmonary disease (ie, Global initiative for chronic Obstructive Lung Disease (GOLD) stage III and IV)
- autoimmune disease (including rheumatoid arthritis and excepting Hashimoto's thyroiditis that had been clinically stable for ≥5 years)
- diabetes mellitus type I
- poorly controlled diabetes mellitus type II
- advanced arteriosclerotic disease
- history of underlying medical condition such as major congenital abnormalities requiring surgery, chronic treatment, or associated with developmental delay (Down's syndrome), acute or progressive hepatic disease
- acute or progressive renal disease
- severe neurological (especially Guillain-Barré syndrome) or psychiatric disorder
- severe asthma
- history of any anaphylactic reaction and/or serious allergic reaction to any component of the study vaccine;
- a known or suspected (or had a high risk of developing) impairment/alteration of immune function (excluding those 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 within the past 6 months,
- receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivates within the past 3 months and for the full length of the study, or
- suspected or known human immunodeficiency virus (HIV) infection or HIV-related disease
- Had known or suspected drug or alcohol abuse within the past 2 years;
- Had bleeding diathesis or conditions associated with prolonged bleeding time that, in the investigator's opinion, would interfere with the safety of the subject;
- was not able to comprehend and to follow all required study procedures for the whole period of the study;
- Had a history or any illness that, in the opinion of the investigator, would pose additional risk to the subjects because of participation in the study;
- Had the following within the past 6 months:
- had any laboratory-confirmed seasonal or pandemic influenza disease
- received any seasonal or pandemic influenza vaccine
- Had received any other vaccine within 4 weeks prior to enrollment in this study or who were planning to receive any vaccine during the study;
- Had acute or chronic infections requiring antiviral therapy within the last 7 days;
- Had experienced fever (ie, body temperature \[preferably oral\] ≥38.0°C) within the last 3 days of intended study vaccination;
- Had been participating in any clinical trial with another investigational product 4 weeks prior to first study visit or intends to participate in another clinical study at any time during the conduct of this study;
- was part of study personnel or has close family members conducting this study;
- Had a body mass index (BMI) \>35 kg/m2 (BMI is calculated by dividing the subject's weight in kilograms by the subject's height in meters multiplied by the subject's height in meters);
- was pregnant (confirmed by positive urine pregnancy test) or nursing (breast feeding) or was a female of childbearing potential who refused to use an acceptable method of birth control for the whole duration of the study.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT01885117
Start Date
August 1 2013
End Date
September 1 2013
Last Update
March 12 2014
Active Locations (1)
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1
University Medical Center Hamburg-Eppendorf
Hamburg, Germany, 20359