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Phase 2 N=437 Randomized Prevention

Evaluate Safety & Immunogenicity of a Pandemic Influenza Vaccine (GSK1562902A) in Adults Over 60 Years of Age

Influenza

Enrolled (actual)
437
Serious AEs
11.7%
Results posted
May 2013
Primary outcome: Primary: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease. — 11.3; 9.7; 10.2; 8.8 Titer

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Pandemic influenza vaccine (GSK1562902A) (adjuvanted or not) (Biological); Fluarix (Biological)
Age
Adult, Older Adult · 60+ yrs
Sex
All
Sponsor
GlaxoSmithKline
Primary completion
Sep 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.
17.6; 12.3; 18.4; 9.8; 7.0; 5.6
PRIMARY
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease.
3.3; 1.6; 5.4; 1.8; 1.3; 1.1
PRIMARY
Number of Seroprotected Subjects Against 2 Strains of Influenza Disease
32; 6; 25; 2; 4; 1
PRIMARY
Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.
218.2; 260.9; 97.8; 134.5
PRIMARY
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease.
8; 2; 9; 2; 4; 1
PRIMARY
Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease.
18; 22; 6; 16
PRIMARY
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.
17.6; 12.3; 18.4; 9.8; 7.0; 5.6
PRIMARY
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.
17.6; 12.3; 18.4; 9.8; 7.0; 5.6
PRIMARY
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.
17.6; 12.3; 18.4; 9.8; 7.0; 5.6
PRIMARY
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease.
8; 2; 9; 2; 4; 1
PRIMARY
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease.
8; 2; 9; 2; 4; 1
PRIMARY
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease.
8; 2; 9; 2; 4; 1
PRIMARY
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease.
3.3; 1.6; 5.4; 1.8; 1.3; 1.1
PRIMARY
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
1.5; 1.3; 1.9; 1.4; 1.4; 1.1
PRIMARY
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
1.5; 1.3; 1.9; 1.4; 1.4; 1.1
PRIMARY
Number of Seroprotected Subjects Against 2 Strains of Influenza Disease
32; 6; 25; 2; 4; 1
PRIMARY
Number of Seroprotected Subjects Against 2 Strains of Influenza Disease
32; 6; 25; 2; 4; 1
PRIMARY
Number of Seroprotected Subjects Against 2 Strains of Influenza Disease
32; 6; 25; 2; 4; 1
PRIMARY
Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease.
18; 22; 6; 16
PRIMARY
Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease.
18; 22; 6; 16
PRIMARY
Number of Seroconverted Subjects for Neutralizing Antibody Response Against 2 Strains of Influenza Disease.
18; 22; 6; 16
PRIMARY
Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.
218.2; 260.9; 97.8; 134.5
PRIMARY
Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.
218.2; 260.9; 97.8; 134.5
PRIMARY
Neutralizing Antibody Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Two Strains of Influenza Disease.
218.2; 260.9; 97.8; 134.5
SECONDARY
Number of Subjects With Adverse Events of Specific Interest (AESIs)
SECONDARY
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
1; 0; 5; 1; 10; 0
SECONDARY
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters.
148; 55; 141; 47; 13; 5
SECONDARY
Number of Subjects With Serious Adverse Events (SAEs)
1; 1; 1; 1; 5; 3
SECONDARY
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
36; 16; 28; 8; 5; 2
SECONDARY
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters.
148; 55; 141; 47; 13; 5
SECONDARY
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells.
393.71; 494.27; 495.77; 545.37; 388.69; 461.29
SECONDARY
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells.
393.71; 494.27; 495.77; 545.37; 388.69; 461.29
SECONDARY
Number of Subjects With Abnormalities in Assessed Biochemical and Hematological Laboratory Parameters.
148; 55; 141; 47; 13; 5
SECONDARY
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells.
393.71; 494.27; 495.77; 545.37; 388.69; 461.29
SECONDARY
Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4/CD8 T-cells
1247.34; 760.03; 1515.07; 850.48; 1188.86; 729.72
SECONDARY
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
13; 5; 13; 1; 1; 0

Summary

The present study is designed to evaluate the immunogenicity and safety of a single or double dose of the pandemic influenza candidate vaccine (GSK1562902A), administered following a two-administration schedule (21 days apart) in adults over 60 years of age. The persistence of influenza antibodies will also be evaluated 24 months after vaccination.

Eligibility Criteria

Inclusion Criteria

  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
  • A male or female aged 61 years or above at the time of the first vaccination.
  • Written informed consent obtained from the subject.
  • Healthy subjects or subjects with well controlled underlying disease.

Exclusion Criteria

  • Administration of the licensed MF59-containing vaccines, e.g. Fluad™ or Addigrip™ or virosome-based influenza vaccines such as Inflexal V™, InfectoVac Flu™ or Invivac™ during the 2006-2007 influenza season.
  • Administration of licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study.
  • Planned administration of a vaccine not foreseen by the study protocol up to 30 days after the second vaccination with H5N1 vaccine.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first administration of the study vaccine.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
  • History of chronic alcohol consumption and/or drug abuse.
  • History of hypersensitivity to vaccines.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine (including egg and thiomersal allergy).
  • Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
  • Acute disease at the time of enrolment.
  • Serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the first vaccination or during the study.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to the first vaccination, or planned use during the study period.
  • Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00397215). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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