Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
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 response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) or Hemagglutination Inhibition (HI) at approximately 21 days post immunization.
The vaccine composition will be based on the World Health Organization (WHO) recommended influenza strains for the 2013/2014 Northern Hemisphere vaccine.
The results of this study are intended to support the use of this vaccine in future influenza seasons if the recommended vaccine composition remains the same, in compliance with the requirements of the current European Union (EU) recommendations for clinical trials related to yearly licensing of influenza vaccines.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
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
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:
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 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.
Primary purpose
Allocation
Interventional model
Masking
125 participants in 2 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal