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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00706563
First received: June 25, 2008
Last updated: October 8, 2009
Last verified: October 2009
  Purpose

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.


Condition Intervention Phase
Seasonal Influenza
Biological: Fluarix™
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase III Study for Evaluation of Immunogenicity and Reactogenicity of Fluarix™ / Influsplit SSW® 2008/2009 in People Aged 18 Years or Above

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Hemagglutination Inhibition (HI) Antibody Titer [ Time Frame: At Day 0 and 21 ] [ Designated as safety issue: No ]
  • Number of Subjects With HI Antibody Titer Above the Cut-off Value [ Time Frame: At Day 0 and 21 ] [ Designated as safety issue: No ]
  • Number of Seroprotected Subjects [ Time Frame: At Day 0 and 21 ] [ Designated as safety issue: No ]
  • Number of Serconverted Subjects [ Time Frame: At Day 21 ] [ Designated as safety issue: No ]
  • Serconversion Factor [ Time Frame: At Day 21 ] [ Designated as safety issue: No ]
  • Seroprotection Power [ Time Frame: At Day 21 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Subjects Reporting Solicited Symptoms [ Time Frame: During the 4-day (Day 0-3) post-vaccination period ] [ Designated as safety issue: No ]
  • Number of Subjects Reporting Unsolicited Adverse Events (AE) [ Time Frame: During the 21-day (Day 0-20) post-vaccination period ] [ Designated as safety issue: No ]
  • Number of Subjects Reporting Serious Adverse Events (SAE) [ Time Frame: During the 21-day (Day 0-20) post-vaccination period ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: July 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluarix Adult Group
Subjects who are 18-40 years of age received one dose of Fluarix™.
Biological: Fluarix™
Single intramuscular dose on Day 0
Other Name: Influsplit
Experimental: Fluarix Elderly Group
Subjects who are ≥ 60 years of age received one dose of Fluarix™.
Biological: Fluarix™
Single intramuscular dose on Day 0
Other Name: Influsplit

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT00706563

Locations
Germany
GSK Investigational Site
Dresden, Sachsen, Germany, 01099
GSK Investigational Site
Dresden, Sachsen, Germany, 01097
GSK Investigational Site
Dresden, Sachsen, Germany, 01129
GSK Investigational Site
Dresden, Sachsen, Germany, 01277
GSK Investigational Site
Freital, Sachsen, Germany, 01705
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00706563     History of Changes
Other Study ID Numbers: 111631
Study First Received: June 25, 2008
Results First Received: July 16, 2009
Last Updated: October 8, 2009
Health Authority: Germany: Paul-Ehrlich-Institut

ClinicalTrials.gov processed this record on November 20, 2014