Study of GSK Biologicals' Influenza Vaccine Arepanrix™ in Japanese Adults 65 Years of Age or Older

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01114620
First received: April 29, 2010
Last updated: March 21, 2013
Last verified: March 2013
  Purpose

The purpose of this study is to comply with the post marketing condition to the exceptional approval of Arepanrix™ in Japan and to assess the immunogenicity and safety of GSK Biologicals' H1N1 influenza vaccine healthy Japanese adults 65 years of age or older.


Condition Intervention Phase
H1N1 Subtype Influenza A
Biological: (GSK2340274A) Arepanrix™
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety Study of GSK Biologicals' Influenza Vaccine Arepanrix™ (GSK2340274A) in Adults 65 Years of Age or Older

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Humoral immune response in terms of hemagglutination inhibition (HI) antibodies against the vaccine virus [ Time Frame: 21 days after the vaccine dose (Day 21) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Humoral immune response in terms of HI antibodies against the vaccine virus [ Time Frame: at Day 0, Day 21 and Day 182 ] [ Designated as safety issue: No ]
  • Humoral immune response in terms of neutralizing antibodies against the vaccine virus [ Time Frame: at Day 0, Day 21 and Day 182 ] [ Designated as safety issue: No ]
  • Solicited local and general symptoms [ Time Frame: during a 7-day follow-up period after vaccination ] [ Designated as safety issue: No ]
  • Unsolicited adverse events and medically attended adverse events [ Time Frame: within 21 days after vaccination (Day 0 - Day 20) and 42 days after vaccination (Day 0 - Day 41) ] [ Designated as safety issue: No ]
  • Occurrence of potential immune-mediated disease and serious adverse events [ Time Frame: during the entire study period (Day 0 until study conclusion on Day 182) ] [ Designated as safety issue: No ]
  • Clinical hematology and biochemistry laboratory abnormalities and urinalysis abnormalities [ Time Frame: at Day 0 and Day 7 ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: May 2010
Study Completion Date: December 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study group
Subjects receive one dose of the study vaccine GSK2340274A registered in Japan under the tradename Arepanrix™
Biological: (GSK2340274A) Arepanrix™
Intramuscular administration, one dose

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Japanese male and female adults 65 years of age or older at time of vaccination.
  • Subjects who the investigator believes can and will comply with the requirements of the protocol.
  • Written informed consent obtained from the subject.
  • Good general health as assessed by medical history and physical examination.
  • Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or other multiple-user device.
  • Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause.
  • Female subjects of childbearing potential may be enrolled in the study, if the subject:

    • has practiced adequate contraception for 30 days prior to vaccination, and
    • has a negative pregnancy test on the day of vaccination, and
    • has agreed to continue adequate contraception and for 2 months after study vaccination.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the dose of study vaccine, or planned use during the study period.
  • History of previous administration of a pandemic H1N1 vaccine.
  • Presence of significant acute or chronic, uncontrolled medical or psychiatric illness.
  • Presence or evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
  • Presence of an axillary temperature >= 37.5 °C, or acute symptoms greater than "mild" severity on the scheduled date of vaccination.
  • Diagnosed with cancer, or treatment for cancer within three years.

    • Persons with a history of cancer who are disease-free without treatment for three years or more are eligible.
    • Persons with a history of histologically-confirmed basal cell carcinoma of the skin successfully treated with local excision only are accepted and may enrol, but other histologic types of skin cancer are exclusionary.
    • Women who are disease-free three years or more after treatment for breast cancer and receiving long-term prophylactic tamoxifen are excepted and may enroll.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
  • Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune modifying drugs within 6 months of study enrolment or planned administration during the study period. For corticosteroids, this will mean a dose equivalent to 10 mg/day of prednisone or equivalent when administered for > 2 weeks. Topical, intra-articularly injected, or inhaled glucocorticoids, topical calcineurin inhibitors or imiquimod are allowed.
  • Receipt of any immunoglobulins and/or any blood products within three months of study enrolment or planned administration of any of these products during the study period.
  • Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin outside of 24 hours prior to vaccination are eligible. Persons receiving prophylactic antiplatelet medications, e.g., low-dose aspirin, and without a clinically-apparent bleeding tendency, are eligible.
  • An acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 months of receipt of seasonal influenza vaccination.
  • Administration of any vaccines within 30 days before vaccination or planned administration before blood sampling at Day 21 and within 30 days prior to blood sampling at Day 182.
  • Any known or suspected allergy to any constituent of influenza vaccines or component used in the manufacturing process of the study vaccine; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
  • Excessive underweight [Body Mass Index (BMI) < 18.5] or excessive obesity (BMI >= 30).
  • Any conditions which, in the opinion of the investigator, prevents the subjects from participating in the study.
  • Clinically or virologically confirmed influenza infection within 12 months preceding the study start.
  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: NCT01114620

Locations
Japan
GSK Investigational Site
Fukuoka, Japan, 813-8588
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01114620     History of Changes
Other Study ID Numbers: 114270
Study First Received: April 29, 2010
Last Updated: March 21, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:
elderly
post-marketing
H1N1
Clinical trial
pandemic 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 August 20, 2014