A Study for Evaluation of Immunogenicity and Reactogenicity of FluarixTM / Influsplit SSW® 2009/2010 in Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00920374
First received: June 12, 2009
Last updated: March 14, 2013
Last verified: March 2013
  Purpose

This study is designed to test the immunogenicity and reactogenicity of the FluarixTM/Influsplit SSW® influenza vaccine containing the influenza strains recommended for the 2009-2010 season.


Condition Intervention Phase
Seasonal Influenza
Biological: Fluarix™/Influsplit SSW®
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: 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 FluarixTM / Influsplit SSW® 2009/2010 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: Day 0 and Day 21 ] [ Designated as safety issue: No ]
    Titers given as geometric mean titer (GMT) were presented for all three vaccine influenza virus strains

  • Number of Subjects With HI Antibody Titer Above the Cut-off Value [ Time Frame: Day 0 and Day 21 ] [ Designated as safety issue: No ]
    The cut-off value assessed was ≥ 1:10 and was presented for all three vaccine influenza virus strains

  • Number of Seroprotected Subjects [ Time Frame: Day 0 and Day 21 ] [ Designated as safety issue: No ]
    A seroprotected subject is a subject with a serum HI antibody titer ≥ 1:40

  • Number of Seroconverted Subjects [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
    A seroconverted subject is a subject with a pre-vaccination serum HI titer < 1:10 and a post-vaccination serum HI titer ≥ 1:40, or a pre-vaccination serum HI titer ≥ 1:10 and a fold increase (Day 21/Day 0) ≥ 4

  • Seroconversion Factor [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
    Seroconversion factor, defined as the fold increase in serum HI GMT post-vaccination compared to pre-vaccination (Day 0), is presented for all three vaccine influenza virus strains

  • Seroprotection Power [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
    Seroprotection power is defined as the number of subject who had a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40


Secondary Outcome Measures:
  • Number of Subjects Reporting Solicited Local Symptoms [ Time Frame: During the 4-day (Day 0-3) post-vaccination period ] [ Designated as safety issue: No ]
    Solicited local symptoms assessed include ecchymosis, induration, pain, redness, and swelling.

  • Number of Subjects Reporting Solicited General Symptoms [ Time Frame: During the 4-day (Day 0-3) post-vaccination period ] [ Designated as safety issue: No ]
    Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, shivering, sweating, and fever

  • 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 ]
    An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

  • Number of Subjects Reporting Serious Adverse Events (SAE) [ Time Frame: During the entire study period ] [ Designated as safety issue: No ]
    An SAE is any untoward medical occurrence that: results in death, is lifethreatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.


Enrollment: 118
Study Start Date: June 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluarix Adult Group
Subjects who are 18-60 years of age received one dose of Fluarix™
Biological: Fluarix™/Influsplit SSW®
single intramuscular dose on Day 0
Experimental: Fluarix Elderly Group
Subjects who are > 60 years of age received one dose of Fluarix™
Biological: Fluarix™/Influsplit SSW®
single intramuscular dose on Day 0

  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 other than the study vaccine(s) within 30 days preceding the vaccination or planned use during the study period.
  • Chronic administration 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 6 months 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 6 months 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00920374

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00920374     History of Changes
Other Study ID Numbers: 113018
Study First Received: June 12, 2009
Results First Received: April 22, 2010
Last Updated: March 14, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by GlaxoSmithKline:
Influenza

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 23, 2014