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Evaluate Safety & Immunogenicity of GSK Bio's Influenza Vaccine GSK576389A After Repeated Vaccination in Elderly Adults
This study has been completed.
First Received: October 1, 2007   Last Updated: October 23, 2008   History of Changes
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00538213
  Purpose

Since influenza vaccines are administered every year because of the frequent change in their antigenic composition, the safety and immunogenicity profile of GSK Biologicals' influenza vaccine GSK576389A will be re-evaluated after repeated vaccine administration. In this study, the subjects previously enrolled in study 104887 will receive a dose with the 2007-2008 season's formulations of Fluarix or GSK576389A. Only subjects who were previously enrolled in study 104887 are eligible for participation in this study.


Condition Intervention Phase
Influenza
Biological: GSK Bio's Influenza Vaccine GSK576389A
Biological: Fluarix™
Phase II

Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title: Reactogenicity and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK576389A in Elderly Adults (≥66 Years) Previously Vaccinated With the Same Candidate Vaccine. Fluarix™ Will be Used as Reference.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence, intensity, duration and relationship to vaccination of solicited local and general signs and symptoms in each group. [ Time Frame: During a 7-day follow-up period after vaccination ] [ Designated as safety issue: Yes ]
  • Occurrence, intensity, duration and relationship to vaccination of unsolicited adverse events (AEs) in each group. [ Time Frame: During a 21-day follow-up period after vaccination ] [ Designated as safety issue: Yes ]
  • Occurrence, intensity, duration & relationship to vaccination of medically significant conditions prompting emergency room visits, hospitalizations or physician visits & that are not routine visits for physical examination or vaccination in each group [ Time Frame: During a 21-day follow-up period after vaccination ] [ Designated as safety issue: Yes ]
  • Occurrence and relationship to vaccination of serious adverse events in each group. [ Time Frame: During the entire study period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Serum Haemagglutinin Inhibition (HI) antibody titer, against each of the three vaccine strains, in each group. [ Time Frame: At Days 0 and 21 ] [ Designated as safety issue: No ]
  • Geometric mean titers (GMTs) of HI antibody titers, in each group. [ Time Frame: At Days 0 and 21 ] [ Designated as safety issue: No ]
  • Seroconversion rates in each group. [ Time Frame: At Day 21 ] [ Designated as safety issue: No ]
  • Seroconversion factors in each group. [ Time Frame: At Day 21 ] [ Designated as safety issue: No ]
  • Seroprotection rates in each group. [ Time Frame: At Days 0 and 21 ] [ Designated as safety issue: No ]
  • Frequency of cytokine-positive CD4/CD8 cells per 10E6 in tests producing at least two different cytokines in each group. [ Designated as safety issue: No ]
  • Frequency of cytokine-positive CD4/CD8 cells per 10E6 in tests producing at least CD40L and another signal molecule in each group. [ Designated as safety issue: No ]
  • Frequency of cytokine-positive CD4/CD8 cells per 10E6 in tests producing at least IL-2 and another signal molecule in each group. [ Designated as safety issue: No ]
  • Frequency of cytokine-positive CD4/CD8 cells per 10E6 in tests producing at least IFN-γ and another signal molecule in each group. [ Designated as safety issue: No ]
  • Frequency of cytokine-positive CD4/CD8 cells per 10E6 in tests producing at least TNFα and another signal molecule in each group. [ Designated as safety issue: No ]
  • For each test, geometric mean (GM) of specific influenza CD4/CD8 T lymphocytes, in each group. [ Time Frame: At Days 0 and 21 ] [ Designated as safety issue: No ]

Enrollment: 133
Study Start Date: October 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group B: Active Comparator
Young adults (19-42 years)
Biological: Fluarix™
Single dose, Intramuscular injection
Group A: Experimental
Elderly adults (≥66 years)
Biological: GSK Bio's Influenza Vaccine GSK576389A
Single dose, Intramuscular injection
Group C: Active Comparator
Elderly adults (≥66 years)
Biological: Fluarix™
Single dose, Intramuscular injection

Detailed Description:

This study is a year 2 revaccination study. First year revaccination was done in study 104887 (NCT00386698).

Primary study was study 104886 (NCT00318149). This study involves 2 age groups (based on primary study):

Subjects enrolled in the >=65 yrs age group in the primary study. Subjects enrolled in the 18-40 yrs age group in the primary study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who were previously vaccinated with GlaxoSmithKline Biologicals Fluarix™ or FluAS25 vaccines in the 104887 study (NCT00386698).
  • 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 between 19 and 42 years or 66 years and older at the time of the vaccination.
  • Written informed consent obtained from the subject.
  • Free of an acute aggravation of the health status as established by clinical evaluation 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 vaccines within 30 days prior to vaccination, or planned use during the study period.
  • Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 21 days after vaccination.
  • Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
  • Vaccination against influenza since January 2007 with the Northern Hemisphere 2007/2008 influenza vaccine or 2006/2007 influenza vaccine.
  • History of confirmed influenza infection since the date of previous vaccination.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine. (For corticosteroids, this will mean prednisone, or equivalent, >=0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
  • History of hypersensitivity to a previous dose of influenza vaccine.
  • History of allergy or reactions likely to be exacerbated by any component of the vaccine(s)
  • Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation (medical history and medical history directed physical examination) or pre-existing laboratory screening tests.
  • Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Axillary temperature <37.5°C / Oral temperature of <37.5°C).
  • Administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the study vaccine or planned administration during the study.
  • Any medical conditions in which intramuscular injections are contraindicated.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00538213

Locations
Belgium
GSK Investigational Site
Gent, Belgium, 9000
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GSK ( Study Director )
Study ID Numbers: 110263
Study First Received: October 1, 2007
Last Updated: October 23, 2008
ClinicalTrials.gov Identifier: NCT00538213     History of Changes
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by GlaxoSmithKline:
Influenza vaccine GSK576389A
Fluarix
Influenza infection

Study placed in the following topic categories:
Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

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

ClinicalTrials.gov processed this record on September 11, 2009