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Immunogenicity and Safety of Vaccine GSK2340272A (H1N1) and GSK Biologicals Fluarix™ Vaccine When Co-administered in Elderly

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00968890
First received: August 27, 2009
Last updated: February 17, 2011
Last verified: February 2011
  Purpose

The purpose of the present study is to assess the immunogenicity, safety and reactogenicity of a two-dose schedule with vaccine GSK2340272A when co-administered with GSK Biologicals' Fluarix™ vaccine either at the time of first or second vaccination in elderly subjects aged 61 years and older.


Condition Intervention Phase
Influenza Infection
Biological: Pandemrix (Influenza vaccine GSK2340272A)
Biological: Fluarix™
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Influenza GSK2340272A and Fluarix™ 2009-2010 Vaccines When Co-administered in Elderly Subjects Aged 61 Years and Older

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Seroconverted Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix [ Time Frame: 21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group) ] [ Designated as safety issue: No ]

    A seroconverted subject is a subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer < 10 and a postvaccination 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 Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.


  • Number of Seroprotected Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix [ Time Frame: 21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group) ] [ Designated as safety issue: No ]

    A seroprotected subject was a subject with reciprocal HI titers >= 40 against the vaccine homologous virus.

    The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.


  • Geometric Mean Fold Rise (GMFR) After the Second Dose of Pandemrix and After Vaccination With Fluarix [ Time Frame: 21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group) ] [ Designated as safety issue: No ]

    The GMFR is 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 Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.



Secondary Outcome Measures:
  • Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains [ Time Frame: Days 0, 21, 42, 182, 364 ] [ Designated as safety issue: No ]

    Titers are expressed as GMTs.

    The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.


  • Number of Seroconverted Subjects [ Time Frame: at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364 ] [ Designated as safety issue: No ]

    A seroconverted subject is a subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer < 10 and a postvaccination 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 Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.


  • Number of Seroprotected Subjects [ Time Frame: at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364 ] [ Designated as safety issue: No ]
    A seroprotected subject is a subject with reciprocal HI titers >= 40 against the vaccine homologous virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.

  • Geometric Mean Fold Rise (GMFR) [ Time Frame: at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364 ] [ Designated as safety issue: No ]
    The GMFR is 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 Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.

  • Number of Subjects With Titers Equal to or Above Titer 1:10 [ Time Frame: Days 0, 21, 42, 182, 364 ] [ Designated as safety issue: No ]

    The cut-off 1:10 was considered as seropositivity.

    The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.


  • Number of Subjects With Solicited Local and General Symptoms [ Time Frame: Within 7 days (Day 0-Day 6) after each vaccination ] [ Designated as safety issue: No ]
    Solicited local symptoms are pain, redness and swelling at the injection site. They are divided between solicited local symptoms occurring after administration of Pandemrix, Fluarix or Placebo. Solicited general symptoms are fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature (defined as axillary temperature >= 38.0 degrees Celsius).

  • Number of Subjects With Unsolicited Adverse Events (AEs) [ Time Frame: From Day 0 to Day 83 ] [ Designated as safety issue: No ]
    Unsolicited AE covers any AE 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

  • Number of Subjects With Adverse Events of Specific Interest [ Time Frame: From Day 0 to Day 364 ] [ Designated as safety issue: No ]
    Adverse events of specific interest include autoimmune diseases and other immune mediated inflammatory disorders.

  • Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: From Day 0 to Day 364 ] [ Designated as safety issue: No ]
    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.


Enrollment: 168
Study Start Date: September 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pandemrix+Fluarix and Pandemrix+Placebo
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
Biological: Pandemrix (Influenza vaccine GSK2340272A)
Intramuscular injection, 2 doses
Biological: Fluarix™
Intramuscular injection, 1 dose
Other Name: 2009-2010 Northern Hemisphere trivalent seasonal influenza vaccine
Biological: Placebo
Intramuscular injection, 1 dose
Experimental: Pandemrix+Placebo and Pandemrix+Fluarix
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
Biological: Pandemrix (Influenza vaccine GSK2340272A)
Intramuscular injection, 2 doses
Biological: Fluarix™
Intramuscular injection, 1 dose
Other Name: 2009-2010 Northern Hemisphere trivalent seasonal influenza vaccine
Biological: Placebo
Intramuscular injection, 1 dose

Detailed Description:

The study will be conducted in an open manner regarding the administration of vaccine GSK2340272A.

The study will be observer-blind regarding the administration of Fluarix™ and placebo vaccines.

  Eligibility

Ages Eligible for Study:   61 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female subjects 61 years of age or older at the time of the first vaccination
  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
  • Written informed consent obtained from the subject.
  • Satisfactory baseline medical assessment by history and physical examination.
  • Access to a consistent means of telephone contact.

Exclusion Criteria:

  • Previous administration of the 2009 Southern Hemisphere or 2009-2010 Northern Hemisphere seasonal influenza vaccine.
  • Previous administration of a pandemic influenza vaccine.
  • Administration of any vaccine within 30 days before first vaccination.
  • Planned administration of a vaccine not foreseen by the study protocol one month (minimum 30 days) after the second vaccination with vaccine GSK2340272A.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of the study vaccines or planned use during the study period. Potential subjects in the follow-up (i.e., no treatment) phase of a prior investigational study may be enrolled if the investigator's judgment is that it will have no effect on safety, reactogenicity, or immunogenicity endpoints in this study, and that it does not violate the protocol requirements of the prior trial.
  • Presence of 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 oral temperature >= 37.5°C, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
  • Diagnosed with cancer, or treatment for cancer, within 3 years.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
  • Chronic administration of immunosuppressants or other immune modifying drugs within six months prior to the first vaccination.
  • Receipt of any immunoglobulins and/or any blood products within 3 months preceding the first vaccination or planned administration of any of these products during the entire 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 anti-platelet 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.
  • Serious chronic disease as determined by medical history and physical examination.
  • Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormalities, as determined by physical examination or laboratory screening tests.
  • Any known or suspected allergy to any constituent of influenza vaccines.
  • History of chronic alcohol consumption and/or drug abuse.
  • Clinically or virologically confirmed influenza infection within 6 months preceding the study start.
  • Any conditions which, in the opinion of the investigator, prevents the subjects from participating in the study.
  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: NCT00968890

Locations
Sweden
GSK Investigational Site
Eskilstuna, Sweden, SE-631 88
GSK Investigational Site
Örebro, Sweden, SE-703 62
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00968890     History of Changes
Other Study ID Numbers: 113525
Study First Received: August 27, 2009
Results First Received: February 17, 2011
Last Updated: February 17, 2011
Health Authority: Sweden: Medical Products Agency

Keywords provided by GlaxoSmithKline:
GSK Bio's influenza vaccine GSK2340272A
Influenza infection

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

ClinicalTrials.gov processed this record on November 19, 2014