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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01114620
First Posted: May 3, 2010
Last Update Posted: December 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  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
Influenza Biological: Arepanrix™ Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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:
  • Number of Seroconverted Subjects for Hemagglutination Inhibition (HI) Antibodies [ Time Frame: At Day 21 ]
    Seroconversion (SCR) was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post-vaccination reciprocal titer against the vaccine virus. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).

  • Number of Seroprotected Subjects for HI Antibodies [ Time Frame: At Day 21 ]
    Seroprotection (SPR) was defined as the proportion of subjects with H1N1 reciprocal HI titers equal to or above (≥) 40 against the tested vaccine virus. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).

  • Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease [ Time Frame: At Day 21 ]
    GMFR, also known as seroconversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).


Secondary Outcome Measures:
  • Number of Subjects With HI Antibody Concentrations Above the Cut-off Value [ Time Frame: At Days 0 and 21 ]
    Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).

  • Number of Subjects With HI Antibody Concentrations Above the Cut-off Value [ Time Frame: At Days 0 and 182 ]
    Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).

  • Titers for Serum HI Antibodies Against Flu A/California/7/2009 Strain [ Time Frame: At Days 0 and 21 ]
    Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).

  • Titers for Serum HI Antibodies Against Flu A/California/7/2009 Strain [ Time Frame: At Days 0 and 182 ]
    Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).

  • Number of Seroconverted Subjects for HI Antibodies [ Time Frame: At Day 182 ]
    SCR was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post-vaccination reciprocal titer against the vaccine virus. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).

  • Number of Seroprotected Subjects for HI Antibodies [ Time Frame: At Days 0 and 182 ]
    Seroprotection (SPR) was defined as the proportion of subjects with H1N1 reciprocal HI titers equal to or above (≥) 40 against the tested vaccine virus. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).

  • GMFR for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease [ Time Frame: At Day 182 ]
    GMFR, also known as seroconversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).

  • Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value [ Time Frame: At Days 0 and 21 ]
    Seropositivity cut-off values assessed were equal to or above (≥) 1:8 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/Netherlands/602/2009 (H1N1) (Flu A/Neth/602/09).

  • Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value [ Time Frame: At Days 0 and 182 ]
    Seropositivity cut-off values assessed were equal to or above (≥) 1:8 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/Netherlands/602/2009 (H1N1) (Flu A/Neth/602/09).

  • Titers for Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease [ Time Frame: At Days 0 and 21 ]
    Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:8. The flu strain assessed was Flu A/Netherlands/602/2009 (H1N1) (Flu A/Neth/602/09).

  • Titers for Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease [ Time Frame: At Days 0 and 182 ]
    Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:8. The flu strain assessed was Flu A/Netherlands/602/2009 (H1N1) (Flu A/Neth/602/09).

  • Number of Subjects With Vaccine Response Rate (VRR) for Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease [ Time Frame: At Day 21 ]
    VRR for microneutralization titers was defined as the proportion of vaccinees with at least a 4-fold increase in post-vaccination reciprocal titer relative to Day 0. The flu strain assessed was Flu A/Netherlands/602/2009 (H1N1) (Flu A/Neth/602/09).

  • Number of Subjects With VRR for Neutralizing Antibodies Against Flu A/Netherlands/602/2009 Strain of Influenza Disease [ Time Frame: At Day 182 ]
    VRR for microneutralization titers was defined as the proportion of vaccinees with at least a 4-fold increase in post-vaccination reciprocal titer relative to Day 0. The flu strain assessed was Flu A/Netherlands/602/2009 (H1N1) (Flu A/Neth/602/09).

  • Number of Subjects With Any and Grade 3 Solicited Local Symptoms [ Time Frame: During the 7-day (Days 0-6) post-vaccination period ]
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

  • Number of Days With Solicited Local Symptoms [ Time Frame: During the 7-day (Days 0-6) post-vaccination period ]
    The number of days with any solicited local symptoms reported during the solicited post-vaccination period.

  • Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: During the 7-day (Days 0-6) post-vaccination period ]
    Assessed solicited general symptoms were Fatigue, Headache, Joint pain at other location, Muscle aches, Shivering, Sweating and Fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0°C to ≤ 40.0°C. Related = symptom assessed by the investigator as causally related to the study vaccination.

  • Number of Days With Solicited General Symptoms [ Time Frame: During the 7-day (Days 0-6) post-vaccination period ]
    The number of days with any solicited general symptoms reported during the solicited post-vaccination period.

  • Number of Subjects With Medically Attended AEs (MAEs) [ Time Frame: During the 21-day (Days 0-20) post-vaccination period ]
    MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.

  • Number of Subjects With MAEs [ Time Frame: During the 42-day (Days 0-41) post-vaccination period ]
    MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.

  • Number of Subjects With Potential Immune-mediated Diseases (pIMDs) [ Time Frame: During the entire study period (from Day 0 up to Day 182) ]
    pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.

  • Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels [ Time Frame: At Day 0 and Day 7 ]

    Among hematological and biochemical parameters assessed were alanine aminotransferase (ALAT), albumin, alkaline phosphatase (AP), aspartate aminotransferase (ASAT), basophils, total bilirubin, bilirubin conjugated/direct, cholesterol, chloride, creatine, creatine kinase (CK), eosinophils, gamma-glutamyl transpeptidase (GGT), hematocrit, hemoglobin, potassium, lactate dyhydrogenase (LDH), lymphocytes, monocytes, sodium, neutrophils, platelets, protein, red blood cells, urate/uric acid, blood urea nitrogen (BUN) and white blood cells.

    Unknown = value unknown for the specified time point and laboratory parameter; Below = value below the laboratory reference range defined for the specified time point and laboratory parameter; Within = value within the laboratory reference range defined for the specified time point and laboratory parameter; Above = value above the laboratory reference range defined for the specified time point and laboratory parameter.


  • Number of Subjects With Abnormal Urine Sampling Parameters [ Time Frame: At Day 0 and Day 7 ]
    Among assessed urine sampling parameters were glucose, protein, red blood cells and urobilinogen.

  • Number of Subjects With Unsolicited Adverse Events (AEs) [ Time Frame: During the 21-day (Days 0-20) post-vaccination period ]
    An unsolicited AE covers 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 and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

  • Number of Subjects With Unsolicited AEs [ Time Frame: During the 42-day (Days 0-41) post-vaccination period ]
    An unsolicited AE covers 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 and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

  • Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: During the entire study period (from Day 0 up to Day 182) ]
    SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.


Enrollment: 50
Actual Study Start Date: May 1, 2010
Study Completion Date: December 9, 2010
Primary Completion Date: November 5, 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arepanrix Group
Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
Biological: Arepanrix™
Intramuscular administration, one dose

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01114620


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

Additional Information:
Study Data/Documents: Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 114270
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 114270
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 114270
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 114270
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 114270
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 114270
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 114270
For additional information about this study please refer to the GSK Clinical Study Register

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
First Submitted: April 29, 2010
First Posted: May 3, 2010
Results First Submitted: May 8, 2017
Results First Posted: December 14, 2017
Last Update Posted: December 14, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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
Vaccines
Immunologic Factors
Physiological Effects of Drugs