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Safety Study of Pandemic Candidate Influenza Vaccines in the Elderly Population

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00306995
First Posted: March 27, 2006
Last Update Posted: October 12, 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
Influenza pandemics are caused by viruses that possess an Hemagglutinin molecule to which most of the population lacks immunity. If such virus is pathogenic to human and demonstrates the ability to transmit from person to person, the result is a global outbreak of disease that affects a high percentage of individuals in a short period of time and is likely to cause substantially increased mortality and morbidity in all countries of the world. Recently, purely avian influenza viruses, including the H5N1, H9N2 and H7N7 subtypes, have been directly transmitted to humans, raising concern over the possibility of a new influenza pandemic among the world's immunologically naive populations. In order to face this kind of situation, a pandemic influenza vaccine has to be developed.

Condition Intervention Phase
Influenza Biological: SB218352_15 Biological: SB218352_8 Biological: SB218352_4 Biological: SB218352_2 Biological: SB218352_8AL Biological: SB218352_4AL Biological: SB218352_2AL Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase III, Open, Randomized, Multicenter, Comparative Vaccination Study to Evaluate the Immunogenicity and Reactogenicity of Various Formulations of a Monovalent Candidate Pandemic Influenza A Vaccine in Individuals Over 60 Years of Age

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Serum haemagglutination-inhibition (HI) antibody titers against the influenza A virus strain subtype H9N2 (anti-H9N2) [ Time Frame: At Day 10 post Dose 1 ]
    Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs).

  • Serum HI antibody titers against the influenza A virus strain subtype H9N2 (anti-H9N2) [ Time Frame: At Day 21 post Dose 1 ]
    Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs).

  • Serum HI antibody titers against the influenza A virus strain subtype H9N2 (anti-H9N2) [ Time Frame: At Day 21 post Dose 2 ]
    Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs).

  • Number of seroconverted subjects against influenza A subtype H9N2 [ Time Frame: At Day 10 post Dose 1 ]
    Seroconversion rate was defined as the percentage of vaccinees who had a pre-vaccination HI titer lower than (<) 1:10 and a post-vaccination titre higher than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four-fold increase in post-vaccination titer

  • Number of seroconverted subjects against influenza A subtype H9N2 [ Time Frame: At Day 21 post Dose 1 ]
    Seroconversion rate was defined as the percentage of vaccinees who had a pre-vaccination HI titer < 1:10 and a post-vaccination titre ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four-fold increase in post-vaccination titer

  • Number of seroconverted subjects against influenza A subtype H9N2 [ Time Frame: At Day 21 post Dose 2 ]
    Seroconversion rate was defined as the percentage of vaccinees who had a pre-vaccination HI titer < 1:10 and a post-vaccination titre ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four-fold increase in postvaccination titer

  • Seroconversion factor for influenza A subtype H9N2 [ Time Frame: At Day 10 post Dose 1 ]
    Seroconversion factor was defined as the fold increase in serum HI GMTs on day 10 compared to day 0.

  • Seroconversion factor for influenza A subtype H9N2 [ Time Frame: At Day 21 post Dose 1 ]
    Seroconversion factor was defined as the fold increase in serum HI GMTs on day 21 compared to day 0.

  • Seroconversion factor for influenza A subtype H9N2 [ Time Frame: At Day 21 post Dose 2 ]
    Seroconversion factor defined as the fold increase in serum HI GMTs on day 42 (day 21 post Dose 2) compared to day 0.

  • Number of seroprotected subjects against H9N2 [ Time Frame: At Day 10 post Dose 1 ]
    Seroprotection rate was defined as the percentage of vaccinees with a serum HI titer ≥40 after vaccination (for each vaccine strain) that usually was accepted as indicating protection.

  • Number of seroprotected subjects against H9N2 [ Time Frame: At Day 21 post Dose 1 ]
    Seroprotection rate was defined as the percentage of vaccinees with a serum HI titer ≥40 after vaccination (for each vaccine strain) that usually was accepted as indicating protection.

  • Number of seroprotected subjects against H9N2 [ Time Frame: At Day 21 post Dose 2 ]
    Seroprotection rate was defined as the percentage of vaccinees with a serum HI titer ≥40 after vaccination (for each vaccine strain) that usually was accepted as indicating protection.

  • Number of subjects with seroprotection power against H9N2 [ Time Frame: At Day 10 post Dose 1 ]
    Seroprotection power was defined as the proportion of subjects who were unprotected prior to the vaccination (HI titer < 1:40 on day 0) and had a protective post-vaccination titer of ≥ 1:40.

  • Number of subjects with seroprotection power against H9N2 [ Time Frame: At Day 21 post Dose 1 ]
    Seroprotection power was defined as the proportion of subjects who were unprotected prior to the vaccination (HI titer < 1:40 on day 0) and had a protective post-vaccination titer of ≥ 1:40.

  • Number of subjects with seroprotection power against H9N2 [ Time Frame: At Day 21 post Dose 2 ]
    Seroprotection power was defined as the proportion of subjects who were unprotected prior to the vaccination (HI titer < 1:40 on day 0) and had a protective post-vaccination titer of ≥ 1:40.


Secondary Outcome Measures:
  • Number of subjects with solicited local symptoms [ Time Frame: During the 4-days (Day 0-3) after each vaccination ]
    Assessed solicited local symptoms were pain, redness, swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = pain which prevents normal everyday activities. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm).

  • Number of subjects with solicited general symptoms [ Time Frame: During the 4 Days (Day 0-3) post Dose 1 ]
    Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axilar temperature higher than (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to the study vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 fever = fever higher than (>) 39°C. Related symptom = symptom assessed by the investigator as being casually related to the study vaccination.

  • Number of subjects with solicited general symptoms [ Time Frame: During the 4-Days (Day 0-3) post Dose 2 ]
    Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axilar temperature higher than (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to the study vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 fever = fever higher than (>) 39°C. Related symptom = symptom assessed by the investigator as being casually related to the study vaccination.

  • Number of subjects with solicited general symptoms [ Time Frame: During the 4-Days (Day 0-3) across vaccination doses ]
    Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axilar temperature higher than (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to the study vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 fever = fever higher than (>) 39°C. Related symptom = symptom assessed by the investigator as being casually related to the study vaccination.

  • Number of subjects with unsolicited adverse events (AEs) [ Time Frame: During the 30-days (Day 0-30) post vaccination ]
    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 dur-ing the clinical study and any solicited symptom with onset out-side 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.

  • Number of subjects with serious adverse events (SAEs) [ Time Frame: From Day 0 to Day 51 ]
    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.

  • Frequency of antigen-specific cluster of differentiation 4 (CD4) T-cells [ Time Frame: At Days 0, 10, 21 and 42 post vaccination ]
    Among expressed immune markers were interferon-gamma (IFN-γ) and cluster of differentiation 40 - ligand (CD40-L).

  • Frequency of antigen-specific CD4 T-cells [ Time Frame: At Days 0, 10, 21 and 42 post-vaccination ]
    Among expressed immune markers were interleukin-2 (IL-2), interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α).

  • Cytokine-positive CD4 T-cells frequency [ Time Frame: At Days 10, 21 and 42 post-vaccination ]
    Among expressed immune markers were interleukin-2 (IL-2), interferon-gamma (IFN-γ), tumour necrosis factor-alpha (TNF-α) and cluster of differentiation 40 - ligand (CD40-L).

  • Frequency of antigen-specific cluster of differentiation 8 (CD8) T-cells [ Time Frame: At Days 0, 10, 21 and 42 post-vaccination ]
    Among expressed immune markers were interferon-gamma (IFN-γ) and cluster of differentiation 40 - ligand (CD40-L).

  • Frequency of antigen-specific CD8 T-cells [ Time Frame: At Days 0, 10, 21 and 42 post-vaccination ]
    Among expressed immune markers were interleukin-2 (IL-2) and tumour necrosis factor-alpha (TNF-α).

  • Cytokine-positive CD8 T-cells frequency [ Time Frame: At Days 0, 10 and 21 ]
    Among expressed immune markers were interleukin-2 (IL-2), interferon-gamma (IFN-γ), tumour necrosis factor-alpha (TNF-α) and cluster of differentiation 40 - ligand (CD40-L).


Enrollment: 385
Actual Study Start Date: May 11, 2005
Study Completion Date: July 4, 2006
Primary Completion Date: July 4, 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SB218352_15 Group
Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21.
Biological: SB218352_15
Non-adjuvanted pandemic influenza A formulation 1 vaccine
Experimental: SB218352_8 Group
Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21.
Biological: SB218352_8
Non-adjuvanted pandemic influenza A formulation 2 vaccine
Experimental: SB218352_4 Group
Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21.
Biological: SB218352_4
Non-adjuvanted pandemic influenza A formulation 3 vaccine
Experimental: SB218352_2 Group
Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21.
Biological: SB218352_2
Non-adjuvanted pandemic influenza A formulation 4 vaccine
Experimental: SB218352_8AL Group
Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21.
Biological: SB218352_8AL
Pandemic influenza A formulation 2 aluminium-adjuvanted vaccine
Experimental: SB218352_4AL Group
Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21.
Biological: SB218352_4AL
Pandemic influenza A formulation 3 aluminium-adjuvanted vaccine
Experimental: SB218352_2AL Group
Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21.
Biological: SB218352_2AL
Pandemic influenza A formulation 4 aluminium-adjuvanted vaccine

  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:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol
  • A male or female aged over 60 years at the time of vaccination.
  • Written informed consent obtained from the subject.

Exclusion criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
  • Participation in an earlier study with a candidate pandemic H9N2 vaccine.
  • Acute disease at the time of enrolment.
  • Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Drug and/or alcohol dependency.
  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): NCT00306995


Locations
Germany
GSK Investigational Site
Finsterwalde, Brandenburg, Germany, 03238
GSK Investigational Site
Ketzin, Brandenburg, Germany, 14669
GSK Investigational Site
Tostedt, Niedersachsen, Germany, 21255
GSK Investigational Site
Dresden, Sachsen, Germany, 01219
GSK Investigational Site
Dresden, Sachsen, Germany, 01307
GSK Investigational Site
Geringswalde, Sachsen, Germany, 09326
GSK Investigational Site
Schmiedeberg, Sachsen, Germany, 01762
GSK Investigational Site
Bad Bramstedt, Schleswig-Holstein, Germany, 24576
GSK Investigational Site
Bad Segeberg, Schleswig-Holstein, Germany, 23795
GSK Investigational Site
Elmshorn, Schleswig-Holstein, Germany, 25335
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 102499
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 102499
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: 102499
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 102499
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: 102499
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00306995     History of Changes
Other Study ID Numbers: 102499
First Submitted: February 16, 2006
First Posted: March 27, 2006
Last Update Posted: October 12, 2017
Last Verified: September 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.
URL: http://

Keywords provided by GlaxoSmithKline:
prophylaxis of 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