Clinical trial NCT01114620: Study of GSK Biologicals' Influenza Vaccine Arepanrix™ in Japanese Adults 65 Years of Age or Older
Official title: Immunogenicity and Safety Study of GSK Biologicals' Influenza Vaccine Arepanrix™ (GSK2340274A) in Adults 65 Years of Age or Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Keywords: elderly
post-marketing
H1N1
Clinical trial
pandemic influenza
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-05-03
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Number of Seroconverted Subjects for Hemagglutination Inhibition (HI) Antibodies
timeFrame: At Day 21
measure: Number of Seroprotected Subjects for HI Antibodies
timeFrame: At Day 21
measure: Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease
timeFrame: At Day 21
Secondary outcomes:
measure: Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
timeFrame: At Days 0 and 21
measure: Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
timeFrame: At Days 0 and 182
measure: Titers for Serum HI Antibodies Against Flu A/California/7/2009 Strain
timeFrame: At Days 0 and 21
measure: Titers for Serum HI Antibodies Against Flu A/California/7/2009 Strain
timeFrame: At Days 0 and 182
measure: Number of Seroconverted Subjects for HI Antibodies
timeFrame: At Day 182
measure: Number of Seroprotected Subjects for HI Antibodies
timeFrame: At Days 0 and 182
measure: GMFR for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease
timeFrame: At Day 182
measure: Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
timeFrame: At Days 0 and 21
measure: Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
timeFrame: At Days 0 and 182
measure: Titers for Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease
timeFrame: At Days 0 and 21
measure: Titers for Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease
timeFrame: At Days 0 and 182
measure: Number of Subjects With Vaccine Response Rate (VRR) for Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease
timeFrame: At Day 21
measure: Number of Subjects With VRR for Neutralizing Antibodies Against Flu A/Netherlands/602/2009 Strain of Influenza Disease
timeFrame: At Day 182
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms
timeFrame: During the 7-day (Days 0-6) post-vaccination period
measure: Number of Days With Solicited Local Symptoms
timeFrame: During the 7-day (Days 0-6) post-vaccination period
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
timeFrame: During the 7-day (Days 0-6) post-vaccination period
measure: Number of Days With Solicited General Symptoms
timeFrame: During the 7-day (Days 0-6) post-vaccination period
measure: Number of Subjects With Medically Attended AEs (MAEs)
timeFrame: During the 21-day (Days 0-20) post-vaccination period
measure: Number of Subjects With MAEs
timeFrame: During the 42-day (Days 0-41) post-vaccination period
measure: Number of Subjects With Potential Immune-mediated Diseases (pIMDs)
timeFrame: During the entire study period (from Day 0 up to Day 182)
measure: Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels
timeFrame: At Day 0 and Day 7
measure: Number of Subjects With Abnormal Urine Sampling Parameters
timeFrame: At Day 0 and Day 7
measure: Number of Subjects With Unsolicited Adverse Events (AEs)
timeFrame: During the 21-day (Days 0-20) post-vaccination period
measure: Number of Subjects With Unsolicited AEs
timeFrame: During the 42-day (Days 0-41) post-vaccination period
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: During the entire study period (from Day 0 up to Day 182)
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Ikematsu H, Tenjinbaru K, Li P, Madan A, Vaughn D. Evaluation of immune response following one dose of an AS03A-adjuvanted H1N1 2009 pandemic influenza vaccine in Japanese adults 65 years of age or older. Hum Vaccin Immunother. 2012 Aug;8(8):1119-25. doi: 10.4161/hv.21081. Epub 2012 Aug 1.