A Study for Evaluation of Immunogenicity and Reactogenicity of Fluarix™ / Influsplit SSW® 2008/2009 in Adults

GlaxoSmithKline (GSK) logo

GlaxoSmithKline (GSK)

Status and phase

Completed
Phase 3

Conditions

Influenza

Treatments

Biological: Fluarix™

Study type

Interventional

Funder types

Industry

Identifiers

NCT00706563
111631

Details and patient eligibility

About

This study is designed to test the immunogenicity and reactogenicity of the Fluarix™/Influsplit SSW® influenza vaccine containing the influenza strains recommended for the 2008-2009 season.

Enrollment

120 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
  • A male or female aged 18 years or above at the time of the vaccination.
  • Written informed consent obtained from the subject.
  • Healthy subjects or with well-controlled chronic diseases as established by medical history and clinical examination before entering into the study.
  • If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series

Exclusion criteria

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the vaccination or planned use during the study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study.
  • Administration of an influenza vaccine within 1 year preceding the study start.
  • Administration of an influenza vaccine other than the study vaccine during the entire study
  • Clinically or virologically confirmed influenza infection within 1 year preceding the study start
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Acute disease at the time of enrolment.
  • Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
  • Not stabilized or clinically serious chronic underlying disease.
  • Lactating female.
  • History of chronic alcohol consumption and/or drug abuse.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Any condition which, in the opinion of the investigator, prevents the subject from participation in the study

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 2 patient groups

Fluarix Adult Group
Experimental group
Description:
Subjects who are 18-40 years of age received one dose of Fluarix™.
Treatment:
Biological: Fluarix™
Fluarix Elderly Group
Experimental group
Description:
Subjects who are ≥ 60 years of age received one dose of Fluarix™.
Treatment:
Biological: Fluarix™

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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